FDA Orange Book · Purple Book · EU Union Register
Drug patent and exclusivity expiry
Which listed patents and regulatory exclusivities end soon: US small-molecule drugs, US biologics and EU orphan medicines, from the regulators' own registers.
Sources: FDA Orange Book and Purple Book (public domain); European Commission, Union Register of medicinal products (CC BY 4.0).
Synced 12 Oct 2026
64US drugs whose last listed protection ends within 24 months
691US drugs with unexpired listed patents
0US biologics under exclusivity
204EU orphan market exclusivities running (42 end within 24 months)
For 64 US drugs, the last patent or exclusivity listed in the FDA Orange Book ends within the next 24 months. 0 US biologics are still under reference-product or orphan exclusivity, and 204 EU orphan medicines hold orphan market exclusivity, 42 of which end within 24 months. These are the protections the regulators list. Patent litigation, settlements and other patents not listed with the FDA often change when a generic or biosimilar actually reaches the market, so these dates are not launch dates.
01
US drugs: last listed patent or exclusivity ends within 24 months
64 drugs| Substance | Last listed patent | Last exclusivity | Last listed protection ends |
|---|---|---|---|
| Loxapine Adasuve · NDA 022549 |
23 Oct 2026 US 8387612 |
None listed | 23 Oct 2026 |
| Ropivacaine Naropin · NDA 020533 |
28 Nov 2026 US 7857802 |
None listed | 28 Nov 2026 |
| Pasireotide Diaspartate Signifor · NDA 200677 |
14 Dec 2026 US 7473761, drug substance |
None listed | 14 Dec 2026 |
| Brilliant Blue G Tissueblue · NDA 209569 |
None listed | 20 Dec 2026 ODE-282: Orphan drug exclusivity: indicated to selectively stain the internal limiting membrane (ILM) |
20 Dec 2026 |
| Telavancin Vibativ · NDA 022110 |
1 Jan 2027 US 7531623, drug substance |
None listed | 1 Jan 2027 |
| Methylene Blue Provayblue · NDA 204630 |
None listed | 8 Jan 2027 M-303: Other exclusivity: information added to the clinical studies section to fulfill a post-marketing requirement |
8 Jan 2027 |
| Olodaterol Striverdi Respimat · NDA 203108 |
19 Jan 2027 US 7727984, drug substance |
None listed | 19 Jan 2027 |
| Regadenoson Lexiscan · NDA 022161 |
2 Feb 2027 US 8106183, drug substance · 2 listed |
None listed | 2 Feb 2027 |
| Balsalazide Colazal · NDA 020610 |
24 Feb 2027 US 7625884, incl. paediatric extension · 2 listed |
None listed | 24 Feb 2027 |
| Epoprostenol Veletri · NDA 022260 |
15 Mar 2027 US 8318802 · 2 listed |
None listed | 15 Mar 2027 |
| Oxcarbazepine Trileptal, Oxtellar Xr · NDA 021285 |
13 Apr 2027 US 10220042 · 11 listed |
None listed | 13 Apr 2027 |
| Florbetapir F 18 Amyvid · NDA 202008 |
30 Apr 2027 US 8506929, drug substance · 2 listed |
None listed | 30 Apr 2027 |
| Pregabalin Lyrica, Lyrica Cr · NDA 021446 |
2 May 2027 US 10022447, incl. paediatric extension · 3 listed |
None listed | 2 May 2027 |
| Peramivir Rapivab · NDA 206426 |
7 May 2027 US 8778997 · 2 listed |
None listed | 7 May 2027 |
| Darunavir Prezista · NDA 202895 |
26 Jun 2027 US 7700645, drug substance, incl. paediatric extension |
None listed | 26 Jun 2027 |
| Desvenlafaxine Desvenlafaxine, Pristiq · NDA 204150 |
5 Jul 2027 US 8269040, drug substance |
None listed | 5 Jul 2027 |
| Eribulin Halaven · NDA 201532 |
8 Jul 2027 US RE46965, incl. paediatric extension |
None listed | 8 Jul 2027 |
| Nifurtimox Lampit · NDA 213464 |
None listed | 6 Aug 2027 ODE-319: Orphan drug exclusivity: indicated in pediatric patients (birth to less than 18 years of age and weighing at … |
6 Aug 2027 |
| Pantoprazole Protonix, Protonix Iv, Pantoprazole Sodium, Pantoprazole Sodium In 0.9% Sodium Chloride · NDA 022020 |
7 Dec 2026 US 7544370, incl. paediatric extension |
12 Aug 2027 NPP: New patient population |
12 Aug 2027 |
| Uridine Triacetate Vistogard, Xuriden · NDA 208159 |
17 Aug 2027 US 7776838 |
None listed | 17 Aug 2027 |
| Rasagiline Azilect · NDA 021641 |
27 Aug 2027 US 7815942, drug substance · 2 listed |
None listed | 27 Aug 2027 |
| Chlorhexidine Gluconate Exidine, Chlorhexidine Gluconate, Readyprep Chg, Peridex, Chg Scrub, Cida-stat · NDA 019127 |
2 Oct 2027 US 7935093 |
None listed | 2 Oct 2027 |
| Levocetirizine Dihydrochloride Xyzal Allergy 24hr · NDA 209090 |
16 Oct 2027 US 8633194 |
None listed | 16 Oct 2027 |
| Lubiprostone Amitiza · NDA 021908 |
25 Oct 2027 US 8026393 · 3 listed |
None listed | 25 Oct 2027 |
| Belinostat Beleodaq · NDA 206256 |
27 Oct 2027 US 8835501 |
None listed | 27 Oct 2027 |
| Mannitol Mannitol 10% In Plastic Container, Mannitol 15% In Plastic Container, Mannitol 20% In Plastic Container, Mannitol 25%, Mannitol 5% In Plastic Container, Osmitrol 10% In Water · NDA 020006 |
None listed | 30 Oct 2027 ODE-327: Orphan drug exclusivity: add-on maintenance therapy to improve pulmonary function in adult patients 18 years … |
30 Oct 2027 |
| Fesoterodine Toviaz · NDA 022030 |
7 Dec 2027 US 8088398, incl. paediatric extension · 3 listed |
None listed | 7 Dec 2027 |
| Valganciclovir Valcyte · NDA 022257 |
11 Dec 2027 US 9642911 · 2 listed |
None listed | 11 Dec 2027 |
| Umeclidinium Incruse Ellipta · NDA 205382 |
18 Dec 2027 US 7488827, drug substance |
None listed | 18 Dec 2027 |
| Alcaftadine Lastacaft · NDA 022134 |
23 Dec 2027 US 8664215 · 2 listed |
None listed | 23 Dec 2027 |
| Nicardipine Cardene, Nicardipine Hydrochloride, Cardene In 0.83% Sodium Chloride In Plastic Container, Cardene In 0.86% Sodium Chloride In Plastic Container, Cardene In 4.8% Dextrose In Plastic Container, Nicardipine Hydrochloride In 0.9% Sodium Chloride · NDA 019734 |
26 Dec 2027 US 9364564 · 6 listed |
None listed | 26 Dec 2027 |
| Bosentan Tracleer · NDA 209279 |
28 Dec 2027 US 7959945 |
None listed | 28 Dec 2027 |
| Risedronate Atelvia, Actonel · NDA 022560 |
9 Jan 2028 US 7645460 · 2 listed |
None listed | 9 Jan 2028 |
| Carglumic Acid Carbaglu · NDA 022562 |
None listed | 22 Jan 2028 ODE-345: Orphan drug exclusivity: in pediatric and adult patients as adjunctive therapy to standard of care for the tr… |
22 Jan 2028 |
| Istradefylline Nourianz · NDA 022075 |
28 Jan 2028 US 7727993 · 2 listed |
None listed | 28 Jan 2028 |
| Ciclesonide Alvesco, Omnaris · NDA 021658 |
1 Feb 2028 US 8371292 |
None listed | 1 Feb 2028 |
| Apomorphine Apokyn, Onapgo · NDA 021264 |
None listed | 3 Feb 2028 NP: New product |
3 Feb 2028 |
| Ferric Carboxymaltose Injectafer · NDA 203565 |
15 Feb 2028 US 7754702 · 6 listed |
None listed | 15 Feb 2028 |
| Lenalidomide Revlimid · NDA 021880 |
8 Mar 2028 US 8741929 · 2 listed |
None listed | 8 Mar 2028 |
| Vorinostat Zolinza · NDA 021991 |
18 Mar 2028 US 8450372 · 2 listed |
None listed | 18 Mar 2028 |
| Azilsartan Kamedoxomil Edarbi · NDA 200796 |
26 Mar 2028 US 9066936 |
None listed | 26 Mar 2028 |
| Edoxaban Savaysa · NDA 206316 |
28 Mar 2028 US 9149532 · 2 listed |
18 Oct 2026 M-14: Other exclusivity: additional clinical trial information added to pediatric use subsection |
28 Mar 2028 |
| Clozapine Versacloz, Clozaril · NDA 203479 |
1 May 2028 US 8057811 |
None listed | 1 May 2028 |
| Calcipotriene Sorilux, Dovonex · NDA 022563 |
7 May 2028 US 8263580 |
None listed | 7 May 2028 |
| Albumin Human Optison · NDA 020899 |
None listed | 9 May 2028 NPP: New patient population |
9 May 2028 |
| Venlafaxine Effexor Xr, Venlafaxine Besylate, Venlafaxine Hydrochloride · NDA 020699 |
16 May 2028 US 7776358 |
None listed | 16 May 2028 |
| Pasireotide Pamoate Signifor Lar Kit · NDA 203255 |
23 May 2028 US 9351923 · 3 listed |
None listed | 23 May 2028 |
| Dalbavancin Dalvance · NDA 021883 |
23 May 2028 US 6900175 |
None listed | 23 May 2028 |
| Quazepam Doral · NDA 018708 |
3 Jun 2028 US 7608616 |
None listed | 3 Jun 2028 |
| Azelastine Astepro Allergy, Children's Astepro Allergy · NDA 213872 |
4 Jun 2028 US 8071073 |
None listed | 4 Jun 2028 |
| Sugammadex Bridion · NDA 022225 |
None listed | 12 Jun 2028 PED: Pediatric exclusivity |
12 Jun 2028 |
| Golodirsen Vyondys 53 · NDA 211970 |
28 Jun 2028 US RE47691 |
12 Dec 2026 ODE-280: Orphan drug exclusivity: indicated for the treatment of duchenne muscular dystrophy (dmd) in patients who hav… |
28 Jun 2028 |
| Everolimus Afinitor Disperz, Afinitor, Zortress · NDA 203985 |
1 Jul 2028 US 9006224 |
None listed | 1 Jul 2028 |
| Ospemifene Osphena · NDA 203505 |
9 Jul 2028 US 8642079 |
None listed | 9 Jul 2028 |
| Prucalopride Motegrity · NDA 210166 |
None listed | 10 Jul 2028 M-14: Other exclusivity: additional clinical trial information added to pediatric use subsection |
10 Jul 2028 |
| Fexinidazole Fexinidazole · NDA 214429 |
None listed | 16 Jul 2028 ODE-359: Orphan drug exclusivity: for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoe… |
16 Jul 2028 |
| Zoledronic Acid Reclast, Zoledronic Acid · NDA 021817 |
5 Aug 2028 US 7932241, incl. paediatric extension |
None listed | 5 Aug 2028 |
| Vandetanib Caprelsa · NDA 022405 |
8 Aug 2028 US 8067427 |
None listed | 8 Aug 2028 |
| Bupropion Aplenzin, Forfivo Xl, Wellbutrin Sr, Wellbutrin Xl · NDA 022108 |
23 Aug 2028 US 7674479 |
None listed | 23 Aug 2028 |
| Tacrolimus Astagraf Xl, Prograf, Protopic, Envarsus Xr · NDA 204096 |
30 Aug 2028 US 8664239 · 10 listed |
16 Jul 2028 ODE-360: Orphan drug exclusivity: for prophylaxis of organ rejection in adult and pediatric patients receiving allogen… |
30 Aug 2028 |
| Desoximetasone Topicort · NDA 018594 |
1 Sep 2028 US 8277780 |
None listed | 1 Sep 2028 |
| Sorafenib Nexavar · NDA 021923 |
10 Sep 2028 US 9737488 · 2 listed |
None listed | 10 Sep 2028 |
| Flutemetamol F 18 Vizamyl · NDA 203137 |
16 Sep 2028 US 8916131 |
None listed | 16 Sep 2028 |
| Iopamidol Isovue-200, Isovue-250, Isovue-300, Isovue-370, Isovue-m 200, Isovue-m 300 · NDA 018735 |
None listed | 10 Oct 2028 I-975: New indication: for oral administration to delineate the gastrointestinal tract on computed tomography of the… |
10 Oct 2028 |
Only single-substance products held under a new drug application (NDA) are counted, and discontinued products are left out. The Orange Book lists patents the application holder submits; the FDA does not assess their validity. Patent expiry dates include any patent term extension, and a "paediatric extension" adds six months.
02
US biologics under exclusivity
0 products| Biologic | Company | Reference product exclusivity | Orphan exclusivity |
|---|
Reference product exclusivity is the 12 years from first licensure during which the FDA cannot approve a biosimilar of that product. Dates as listed in the FDA Purple Book (September 2026 release).
03
EU orphan market exclusivity, soonest ending first
204 running| Medicine | Orphan condition | Company | Exclusivity ends |
|---|---|---|---|
| Onivyde pegylated liposomal Nanoliposomal irinotecan · EU/1/16/1130 |
Treatment of pancreatic cancer Designation EU/3/11/933, exclusivity from 18 Oct 2016 |
Les Laboratoires Servier | 18 Oct 2026 |
| Ninlaro Ixazomib · EU/1/16/1094 |
Treatment of multiple myeloma Designation EU/3/11/899, exclusivity from 23 Nov 2016 |
Takeda Pharma A/S | 23 Nov 2026 |
| SomaKit TOC Edotreotide · EU/1/16/1141 |
Diagnosis of gastro-entero-pancreatic neuroendocrine tumours Designation EU/3/15/1450, exclusivity from 12 Dec 2016 |
Novartis Europharm Limited | 12 Dec 2026 |
| Cerdelga Eliglustat · EU/1/14/974 |
Treatment of Gaucher Disease Designation EU/3/07/514, exclusivity from 21 Jan 2015 |
Sanofi B.V. | 21 Jan 2027 incl. 24 months paediatric extension |
| Holoclar Ex vivo expanded autologous human corneal epithelial cells containing stem cells · EU/1/14/987 |
Treatment of corneal lesions, with associated corneal (limbal) stem cell deficiency, due to ocular burns Designation EU/3/08/579, exclusivity from 19 Feb 2015 |
Holostem S.r.l. | 19 Feb 2027 incl. 24 months paediatric extension |
| Ledaga Chlormethine · EU/1/16/1171 |
Treatment of cutaneous T-cell lymphoma Designation EU/3/12/963, exclusivity from 7 Mar 2017 |
Helsinn Birex Pharmaceuticals Ltd | 7 Mar 2027 |
| Chenodeoxycholic acid Leadiant Chenodeoxycholic acid · EU/1/16/1110 |
Treatment of inborn errors of primary bile acid synthesis Designation EU/3/14/1406, exclusivity from 12 Apr 2017 |
Leadiant Biosciences Ireland Limited | 12 Apr 2027 |
| Qarziba Chimeric monoclonal antibody against GD2 · EU/1/17/1191 |
Treatment of neuroblastoma Designation EU/3/12/1062, exclusivity from 11 May 2017 |
Recordati Netherlands B.V. | 11 May 2027 |
| Besponsa Inotuzumab ozogamicin · EU/1/17/1200 |
Treatment of B-cell acute lymphoblastic leukaemia Designation EU/3/13/1127, exclusivity from 3 Jul 2017 |
Pfizer Europe MA EEIG | 3 Jul 2027 |
| OXERVATE Cenegermin · EU/1/17/1197 |
Treatment of neurotrophic keratitis Designation EU/3/15/1586, exclusivity from 10 Jul 2017 |
Dompé farmaceutici S.p.A. | 10 Jul 2027 |
| Strensiq Asfotase alfa · EU/1/15/1015 |
Treatment of hypophosphatasia Designation EU/3/08/594, exclusivity from 1 Sep 2015 |
Alexion Europe SAS | 1 Sep 2027 incl. 24 months paediatric extension |
| Kanuma Sebelipase alfa · EU/1/15/1033 |
Treatment of lysosomal acid lipase deficiency Designation EU/3/10/827, exclusivity from 1 Sep 2015 |
Alexion Europe SAS | 1 Sep 2027 incl. 24 months paediatric extension |
| Rydapt Midostaurin · EU/1/17/1218 |
Treatment of acute myeloid leukaemia Designation EU/3/04/214, exclusivity from 20 Sep 2017 |
Novartis Europharm Limited | 20 Sep 2027 |
| Rydapt Midostaurin · EU/1/17/1218 |
Treatment of mastocytosis Designation EU/3/10/765, exclusivity from 20 Sep 2017 |
Novartis Europharm Limited | 20 Sep 2027 |
| Xermelo Telotristat ethyl · EU/1/17/1224 |
Treatment of carcinoid syndrome Designation EU/3/09/661, exclusivity from 20 Sep 2017 |
Serb | 20 Sep 2027 |
| Cresemba Isavuconazole · EU/1/15/1036 |
Treatment of mucormycosis Designation EU/3/14/1276, exclusivity from 19 Oct 2015 |
Basilea Pharmaceutica Deutschland GmbH | 19 Oct 2027 incl. 24 months paediatric extension |
| Cresemba Isavuconazole · EU/1/15/1036 |
Treatment of invasive aspergillosis Designation EU/3/14/1284, exclusivity from 19 Oct 2015 |
Basilea Pharmaceutica Deutschland GmbH | 19 Oct 2027 incl. 24 months paediatric extension |
| BLINCYTO Blinatumomab · EU/1/15/1047 |
Treatment of acute lymphoblastic leukaemia Designation EU/3/09/650, exclusivity from 25 Nov 2015 |
Amgen Europe B.V. | 25 Nov 2027 incl. 24 months paediatric extension |
| Ravicti Glycerol phenylbutyrate · EU/1/15/1062 |
Treatment of carbamoyl-phosphate synthase-1 deficiency Designation EU/3/10/733, exclusivity from 1 Dec 2015 |
Immedica Pharma AB | 1 Dec 2027 incl. 24 months paediatric extension |
| Ravicti Glycerol phenylbutyrate · EU/1/15/1062 |
Treatment of ornithine carbamoyltransferase deficiency Designation EU/3/10/734, exclusivity from 1 Dec 2015 |
Immedica Pharma AB | 1 Dec 2027 incl. 24 months paediatric extension |
| Ravicti Glycerol phenylbutyrate · EU/1/15/1062 |
Treatment of citrullinaemia type 1 Designation EU/3/10/735, exclusivity from 1 Dec 2015 |
Immedica Pharma AB | 1 Dec 2027 incl. 24 months paediatric extension |
| Ravicti Glycerol phenylbutyrate · EU/1/15/1062 |
Treatment of argininosuccinic aciduria Designation EU/3/10/736, exclusivity from 1 Dec 2015 |
Immedica Pharma AB | 1 Dec 2027 incl. 24 months paediatric extension |
| Ravicti Glycerol phenylbutyrate · EU/1/15/1062 |
Treatment of hyperargininaemia Designation EU/3/10/737, exclusivity from 1 Dec 2015 |
Immedica Pharma AB | 1 Dec 2027 incl. 24 months paediatric extension |
| Ravicti Glycerol phenylbutyrate · EU/1/15/1062 |
Treatment of ornithine translocase deficiency (hyperornithinaemia-hyperammonaemia homocitrullinuria (HHH) syndrome) Designation EU/3/10/738, exclusivity from 1 Dec 2015 |
Immedica Pharma AB | 1 Dec 2027 incl. 24 months paediatric extension |
| Jorveza Budesonide · EU/1/17/1254 |
Treatment of eosinophilic oesophagitis Designation EU/3/13/1181, exclusivity from 10 Jan 2018 |
Dr Falk Pharma GmbH | 10 Jan 2028 |
| Coagadex Human coagulation factor x · EU/1/16/1087 |
Treatment of hereditary factor X deficiency Designation EU/3/07/471, exclusivity from 18 Mar 2016 |
Kedrion S.p.A. | 18 Mar 2028 incl. 24 months paediatric extension |
| Wakix Pitolisant · EU/1/15/1068 |
Treatment of narcolepsy Designation EU/3/07/459, exclusivity from 4 Apr 2016 |
Bioprojet Pharma | 4 Apr 2028 incl. 24 months paediatric extension |
| Mylotarg Gemtuzumab ozogamicin · EU/1/18/1277 |
Treatment of acute myeloid leukaemia Designation EU/3/00/005, exclusivity from 23 Apr 2018 |
Pfizer Europe MA EEIG | 23 Apr 2028 |
| ALPROLIX Eftrenonacog alfa · EU/1/16/1098 |
Treatment of haemophilia B (congenital factor IX deficiency) Designation EU/3/07/453, exclusivity from 13 May 2016 |
Swedish Orphan Biovitrum AB (publ) | 13 May 2028 incl. 24 months paediatric extension |
| IDELVION Albutrepenonacog alfa · EU/1/16/1095 |
Treatment of haemophilia B Designation EU/3/09/723, exclusivity from 13 May 2016 |
CSL Behring GmbH | 13 May 2028 incl. 24 months paediatric extension |
| AMGLIDIA Glibenclamide · EU/1/18/1279 |
Treatment of neonatal diabetes Designation EU/3/15/1589, exclusivity from 28 May 2018 |
AMMTeK | 28 May 2028 |
| Strimvelis Autologous CD34+ cells transfected with retroviral vector containing adenosine … · EU/1/16/1097 |
Treatment of severe combined immunodeficiency (SCID) due to adenosine deaminase (ADA) deficiency Designation EU/3/05/313, exclusivity from 30 May 2016 |
Fondazione Telethon Ets | 30 May 2028 incl. 24 months paediatric extension |
| Tegsedi Inotersen · EU/1/18/1296 |
Treatment of ATTR amyloidosis Designation EU/3/14/1250, exclusivity from 10 Jul 2018 |
Akcea Therapeutics Ireland Limited | 10 Jul 2028 |
| Myalepta Metreleptin · EU/1/18/1276 |
Treatment of Familial Partial Lipodystrophy Designation EU/3/12/1022, exclusivity from 1 Aug 2018 |
Chiesi Farmaceutici S.p.A. | 1 Aug 2028 |
| Myalepta Metreleptin · EU/1/18/1276 |
Treatment of Barraquer-Simons syndrome Designation EU/3/12/1023, exclusivity from 1 Aug 2018 |
Chiesi Farmaceutici S.p.A. | 1 Aug 2028 |
| Myalepta Metreleptin · EU/1/18/1276 |
Treatment of Lawrence syndrome Designation EU/3/12/1024, exclusivity from 1 Aug 2018 |
Chiesi Farmaceutici S.p.A. | 1 Aug 2028 |
| Myalepta Metreleptin · EU/1/18/1276 |
Treatment of Berardinelli-Seip syndrome Designation EU/3/12/1025, exclusivity from 1 Aug 2018 |
Chiesi Farmaceutici S.p.A. | 1 Aug 2028 |
| Kymriah Tisagenlecleucel · EU/1/18/1297 |
Treatment of B-lymphoblastic leukaemia/lymphoma Designation EU/3/14/1266, exclusivity from 27 Aug 2018 |
Novartis Europharm Limited | 27 Aug 2028 |
| Kymriah Tisagenlecleucel · EU/1/18/1297 |
Treatment of diffuse large B-cell lymphoma Designation EU/3/16/1745, exclusivity from 27 Aug 2018 |
Novartis Europharm Limited | 27 Aug 2028 |
| Yescarta Axicabtagene ciloleucel · EU/1/18/1299 |
Treatment of diffuse large B cell lymphoma Designation EU/3/14/1393, exclusivity from 27 Aug 2018 |
Kite Pharma EU B.V. | 27 Aug 2028 |
| Yescarta Axicabtagene ciloleucel · EU/1/18/1299 |
Treatment of primary mediastinal large B-cell lymphoma Designation EU/3/15/1553, exclusivity from 27 Aug 2018 |
Kite Pharma EU B.V. | 27 Aug 2028 |
| Onpattro Patisiran · EU/1/18/1320 |
Treatment of transthyretin-mediated amyloidosis Designation EU/3/11/857, exclusivity from 29 Aug 2018 |
Alnylam Netherlands B.V. | 29 Aug 2028 |
| Symkevi | Treatment of cystic fibrosis Designation EU/3/17/1828, exclusivity from 6 Nov 2018 |
Vertex Pharmaceuticals (Ireland) Limited | 6 Nov 2028 |
| Poteligeo Mogamulizumab · EU/1/18/1335 |
Treatment of cutaneous T-cell lymphoma Designation EU/3/16/1756, exclusivity from 26 Nov 2018 |
Kyowa Kirin Holdings B.V. | 26 Nov 2028 |
| Namuscla Mexiletine · EU/1/18/1325 |
Treatment of myotonic disorders Designation EU/3/14/1353, exclusivity from 20 Dec 2018 |
Lupin Europe GmbH | 20 Dec 2028 |
| Cystadrops Mercaptamine · EU/1/15/1049 |
Treatment of cystinosis Designation EU/3/08/578, exclusivity from 23 Jan 2017 |
Recordati Rare Diseases | 23 Jan 2029 incl. 24 months paediatric extension |
| Palynziq Pegvaliase · EU/1/19/1362 |
Treatment of hyperphenylalaninaemia Designation EU/3/09/708, exclusivity from 8 May 2019 |
BioMarin International Limited | 8 May 2029 |
| Waylivra Volanesorsen · EU/1/19/1360 |
Treatment of familial chylomicronemia syndrome Designation EU/3/14/1249, exclusivity from 8 May 2019 |
Akcea Therapeutics Ireland Limited | 8 May 2029 |
| Spinraza Nusinersen · EU/1/17/1188 |
Treatment of 5q spinal muscular atrophy Designation EU/3/12/976, exclusivity from 1 Jun 2017 |
Biogen Netherlands B.V. | 1 Jun 2029 incl. 24 months paediatric extension |
| Brineura Cerliponase alfa · EU/1/17/1192 |
Treatment of neuronal ceroid lipofuscinosis type 2 Designation EU/3/13/1118, exclusivity from 1 Jun 2017 |
BioMarin International Limited | 1 Jun 2029 incl. 24 months paediatric extension |
| Soliris Eculizumab · EU/1/07/393 |
Treatment of myasthenia gravis Designation EU/3/14/1304, exclusivity from 17 Aug 2017 |
Alexion Europe SAS | 17 Aug 2029 incl. 24 months paediatric extension |
| Soliris Eculizumab · EU/1/07/393 |
Treatment of neuromyelitis optica spectrum disorders Designation EU/3/13/1185, exclusivity from 28 Aug 2019 |
Alexion Europe SAS | 28 Aug 2029 |
| Epidyolex Cannabidiol · EU/1/19/1389 |
Treatment of Dravet syndrome Designation EU/3/14/1339, exclusivity from 23 Sep 2019 |
Jazz Pharmaceuticals Ireland Limited | 23 Sep 2029 |
| Epidyolex Cannabidiol · EU/1/19/1389 |
Treatment of Lennox-Gastaut syndrome Designation EU/3/17/1855, exclusivity from 23 Sep 2019 |
Jazz Pharmaceuticals Ireland Limited | 23 Sep 2029 |
| Lutathera Lutetium 177lu oxodotreotide · EU/1/17/1226 |
Treatment of gastro-entero-pancreatic neuroendocrine tumours Designation EU/3/07/523, exclusivity from 28 Sep 2017 |
Novartis Europharm Limited | 28 Sep 2029 incl. 24 months paediatric extension |
| Xospata Gilteritinib · EU/1/19/1399 |
Treatment of acute myeloid leukaemia Designation EU/3/17/1961, exclusivity from 28 Oct 2019 |
Astellas Pharma Europe B.V. | 28 Oct 2029 |
| Zejula Niraparib · EU/1/17/1235 |
Treatment of ovarian cancer Designation EU/3/10/760, exclusivity from 20 Nov 2017 |
GlaxoSmithKline Trading Services Limited | 20 Nov 2029 incl. 24 months paediatric extension |
| PREVYMIS Letermovir · EU/1/17/1245 |
Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity deemed at risk Designation EU/3/11/849, exclusivity from 10 Jan 2018 |
Merck Sharp & Dohme B.V. | 10 Jan 2030 incl. 24 months paediatric extension |
| Isturisa Osilodrostat · EU/1/19/1407 |
Treatment of Cushing's syndrome Designation EU/3/14/1345, exclusivity from 13 Jan 2020 |
Recordati Rare Diseases | 13 Jan 2030 |
| Polivy Polatuzumab vedotin · EU/1/19/1388 |
Treatment of diffuse large B-cell lymphoma Designation EU/3/18/2013, exclusivity from 20 Jan 2020 |
Roche Registration GmbH | 20 Jan 2030 |
| Vyndaqel Tafamidis · EU/1/11/717 |
Treatment of senile systemic amyloidosis Designation EU/3/12/1066, exclusivity from 19 Feb 2020 |
Pfizer Europe MA EEIG | 19 Feb 2030 |
| CRYSVITA Burosumab · EU/1/17/1262 |
Treatment of X-linked hypophosphataemia Designation EU/3/14/1351, exclusivity from 21 Feb 2018 |
Kyowa Kirin Holdings B.V. | 21 Feb 2030 incl. 24 months paediatric extension |
| Givlaari Givosiran · EU/1/20/1428 |
Treatment of acute hepatic porphyria Designation EU/3/16/1731, exclusivity from 4 Mar 2020 |
Alnylam Netherlands B.V. | 4 Mar 2030 |
| Lamzede Velmanase alfa · EU/1/17/1258 |
Treatment of α-Mannosidosis Designation EU/3/04/260, exclusivity from 27 Mar 2018 |
Chiesi Farmaceutici S.p.A. | 27 Mar 2030 incl. 24 months paediatric extension |
| Trepulmix Treprostinil · EU/1/19/1419 |
Treatment of chronic thromboembolic pulmonary hypertension Designation EU/3/13/1103, exclusivity from 7 Apr 2020 |
SciPharm Sàrl | 7 Apr 2030 |
| Zolgensma Onasemnogene abeparvovec · EU/1/20/1443 |
Treatment of spinal muscular atrophy Designation EU/3/15/1509, exclusivity from 18 May 2020 |
Novartis Europharm Limited | 18 May 2030 |
| Reblozyl Luspatercept · EU/1/20/1452 |
Treatment of beta-thalassaemia intermedia and major Designation EU/3/14/1300, exclusivity from 26 Jun 2020 |
Bristol-Myers Squibb Pharma EEIG | 26 Jun 2030 |
| Reblozyl Luspatercept · EU/1/20/1452 |
Treatment of myelodysplastic syndromes Designation EU/3/14/1331, exclusivity from 26 Jun 2020 |
Bristol-Myers Squibb Pharma EEIG | 26 Jun 2030 |
| Daurismo Glasdegib · EU/1/20/1451 |
Treatment of acute myeloid leukaemia Designation EU/3/17/1923, exclusivity from 29 Jun 2020 |
Pfizer Europe MA EEIG | 29 Jun 2030 |
| Verkazia Ciclosporin · EU/1/17/1219 |
Treatment of vernal keratoconjunctivitis Designation EU/3/06/360, exclusivity from 10 Jul 2018 |
Santen Oy | 10 Jul 2030 incl. 24 months paediatric extension |
| Dovprela (S)-2-nitro-6-(4-(trifluoromethoxy)benzyloxy)-6,7-dihydro-5H-imidazo[2,1-b][1,3… · EU/1/20/1437 |
Treatment of tuberculosis Designation EU/3/07/513, exclusivity from 4 Aug 2020 |
Mylan IRE Healthcare Ltd | 4 Aug 2030 |
| Kaftrio | Treatment of cystic fibrosis Designation EU/3/18/2116, exclusivity from 21 Aug 2020 |
Vertex Pharmaceuticals (Ireland) Limited | 21 Aug 2030 |
| Vyxeos liposomal Liposomal combination of cytarabine and daunorubicin · EU/1/18/1308 |
Treatment of acute myeloid leukaemia Designation EU/3/11/942, exclusivity from 27 Aug 2018 |
Jazz Pharmaceuticals Ireland Ltd | 27 Aug 2030 incl. 24 months paediatric extension |
| Mepsevii Vestronidase alfa · EU/1/18/1301 |
Treatment of mucopolysaccharidosis type VII (Sly syndrome) Designation EU/3/12/973, exclusivity from 27 Aug 2018 |
Ultragenyx Germany GmbH | 27 Aug 2030 incl. 24 months paediatric extension |
| Idefirix Imlifidase · EU/1/20/1471 |
Prevention of graft rejection following solid organ transplantation Designation EU/3/16/1826, exclusivity from 1 Sep 2020 |
Hansa Biopharma AB | 1 Sep 2030 |
| Cablivi Caplacizumab · EU/1/18/1305 |
Treatment of thrombotic thrombocytopenic purpura Designation EU/3/09/629, exclusivity from 4 Sep 2018 |
Ablynx N.V. | 4 Sep 2030 incl. 24 months paediatric extension |
| AYVAKYT Avapritinib · EU/1/20/1473 |
Treatment of gastrointestinal stromal tumours Designation EU/3/17/1889, exclusivity from 25 Sep 2020 |
Blueprint Medicines (Netherlands) B.V. | 25 Sep 2030 |
| ARIKAYCE liposomal Amikacin · EU/1/20/1469 |
Treatment of nontuberculous mycobacterial lung disease Designation EU/3/14/1259, exclusivity from 28 Oct 2020 |
Insmed Netherlands B.V. | 28 Oct 2030 |
| Oxlumo Lumasiran · EU/1/20/1496 |
Treatment of primary hyperoxaluria Designation EU/3/16/1637, exclusivity from 23 Nov 2020 |
Alnylam Netherlands B.V. | 23 Nov 2030 |
| TAKHZYRO Lanadelumab · EU/1/18/1340 |
Treatment of hereditary angioedema Designation EU/3/15/1551, exclusivity from 26 Nov 2018 |
Takeda Pharmaceuticals International AG Ireland Branch | 26 Nov 2030 incl. 24 months paediatric extension |
| Luxturna Voretigene neparvovec · EU/1/18/1331 |
Treatment of inherited retinal dystrophies (initially named treatment of Leber’s congenital amaurosis) Designation EU/3/12/981, exclusivity from 5 Dec 2018 |
Novartis Europharm Limited | 5 Dec 2030 incl. 24 months paediatric extension |
| Luxturna Voretigene neparvovec · EU/1/18/1331 |
Treatment of inherited retinal dystrophies (initially named treatment of retinitis pigmentosa) Designation EU/3/15/1518, exclusivity from 5 Dec 2018 |
Novartis Europharm Limited | 5 Dec 2030 incl. 24 months paediatric extension |
| Tecartus Brexucabtagene autoleucel · EU/1/20/1492 |
Treatment of mantle cell lymphoma Designation EU/3/19/2220, exclusivity from 15 Dec 2020 |
Kite Pharma EU B.V. | 15 Dec 2030 |
| Libmeldy Autologous CD34+ cells transfected with lentiviral vector containing the human … · EU/1/20/1493 |
Treatment of metachromatic leukodystrophy Designation EU/3/07/446, exclusivity from 18 Dec 2020 |
Orchard Therapeutics (Netherlands) B.V. | 18 Dec 2030 |
| Fintepla Fenfluramine · EU/1/20/1491 |
Treatment of Dravet syndrome Designation EU/3/13/1219, exclusivity from 21 Dec 2020 |
UCB Pharma | 21 Dec 2030 |
| ELZONRIS Tagraxofusp · EU/1/20/1504 |
Treatment of blastic plasmacytoid dendritic cell neoplasm Designation EU/3/15/1567, exclusivity from 13 Jan 2021 |
Stemline Therapeutics B.V. | 13 Jan 2031 |
| Inrebic Fedratinib · EU/1/20/1514 |
Treatment of primary myelofibrosis Designation EU/3/10/794, exclusivity from 9 Feb 2021 |
Bristol-Myers Squibb Pharma EEIG | 9 Feb 2031 |
| Inrebic Fedratinib · EU/1/20/1514 |
Treatment of post-essential thrombocythaemia myelofibrosis Designation EU/3/10/810, exclusivity from 9 Feb 2021 |
Bristol-Myers Squibb Pharma EEIG | 9 Feb 2031 |
| Inrebic Fedratinib · EU/1/20/1514 |
Treatment of post-polycythaemia vera myelofibrosis Designation EU/3/10/811, exclusivity from 9 Feb 2021 |
Bristol-Myers Squibb Pharma EEIG | 9 Feb 2031 |
| Pemazyre Pemigatinib · EU/1/21/1535 |
Treatment of biliary tract cancer Designation EU/3/18/2066, exclusivity from 29 Mar 2021 |
Incyte Biosciences Distribution B.V. | 29 Mar 2031 |
| Epidyolex Cannabidiol · EU/1/19/1389 |
Treatment of tuberous sclerosis Designation EU/3/17/1959, exclusivity from 20 Apr 2021 |
Jazz Pharmaceuticals Ireland Limited | 20 Apr 2031 |
| Trecondi Treosulfan · EU/1/18/1351 |
Conditioning treatment prior to haematopoietic progenitor cell transplantation Designation EU/3/04/186, exclusivity from 24 Jun 2019 |
medac Gesellschaft für klinische Spezialpräparate mbH | 24 Jun 2031 incl. 24 months paediatric extension |
| Enspryng Satralizumab · EU/1/21/1559 |
Treatment of neuromyelitis optica spectrum disorders Designation EU/3/16/1680, exclusivity from 29 Jun 2021 |
Roche Registration GmbH | 29 Jun 2031 |
| Imcivree Setmelanotide · EU/1/21/1564 |
Treatment of pro-opiomelanocortin deficiency Designation EU/3/16/1703, exclusivity from 19 Jul 2021 |
Rhythm Pharmaceuticals Netherlands B.V. | 19 Jul 2031 |
| Imcivree Setmelanotide · EU/1/21/1564 |
Treatment of leptin receptor deficiency Designation EU/3/18/2101, exclusivity from 19 Jul 2021 |
Rhythm Pharmaceuticals Netherlands B.V. | 19 Jul 2031 |
| Abecma Idecabtagene vicleucel · EU/1/21/1539 |
Treatment of multiple myeloma Designation EU/3/17/1863, exclusivity from 19 Aug 2021 |
Bristol-Myers Squibb Pharma EEIG | 19 Aug 2031 |
| Minjuvi Tafasitamab · EU/1/21/1570 |
Treatment of diffuse large B-cell lymphoma Designation EU/3/14/1424, exclusivity from 1 Sep 2021 |
Incyte Biosciences Distribution B.V. | 1 Sep 2031 |
| QINLOCK Ripretinib · EU/1/21/1569 |
Treatment of gastrointestinal stromal tumours Designation EU/3/17/1936, exclusivity from 24 Nov 2021 |
Deciphera Pharmaceuticals (Netherlands) B.V. | 24 Nov 2031 |
| ASPAVELI Pegcetacoplan · EU/1/21/1595 |
Treatment of paroxysmal nocturnal haemoglobinuria Designation EU/3/17/1873, exclusivity from 14 Dec 2021 |
Swedish Orphan Biovitrum AB (publ) | 14 Dec 2031 |
| Skytrofa Lonapegsomatropin · EU/1/21/1607 |
Treatment of growth hormone deficiency Designation EU/3/19/2213, exclusivity from 17 Jan 2022 |
Ascendis Pharma Endocrinology Division A/S | 17 Jan 2032 |
| Ngenla Somatrogon · EU/1/21/1617 |
Treatment of growth hormone deficiency Designation EU/3/12/1087, exclusivity from 15 Feb 2022 |
Pfizer Europe MA EEIG | 15 Feb 2032 |
| Oxbryta Voxelotor · EU/1/21/1622 |
Treatment of sickle cell disease Designation EU/3/16/1769, exclusivity from 15 Feb 2022 |
Pfizer Europe MA EEIG | 15 Feb 2032 |
| AYVAKYT Avapritinib · EU/1/20/1473 |
Treatment of mastocytosis Designation EU/3/18/2074, exclusivity from 25 Mar 2022 |
Blueprint Medicines (Netherlands) B.V. | 25 Mar 2032 |
| KIMMTRAK Tebentafusp · EU/1/22/1630 |
Treatment of uveal melanoma Designation EU/3/21/2397, exclusivity from 6 Apr 2022 |
Immunocore Ireland Limited | 6 Apr 2032 |
| Kymriah Tisagenlecleucel · EU/1/18/1297 |
Treatment of follicular lymphoma Designation EU/3/21/2464, exclusivity from 3 May 2022 |
Novartis Europharm Limited | 3 May 2032 |
| CARVYKTI Ciltacabtagene autoleucel · EU/1/22/1648 |
Treatment of multiple myeloma Designation EU/3/20/2252, exclusivity from 30 May 2022 |
Janssen-Cilag International NV | 30 May 2032 |
| Lunsumio Mosunetuzumab · EU/1/22/1649 |
Treatment of follicular lymphoma Designation EU/3/21/2517, exclusivity from 7 Jun 2022 |
Roche Registration GmbH | 7 Jun 2032 |
| Yescarta Axicabtagene ciloleucel · EU/1/18/1299 |
Treatment of follicular lymphoma Designation EU/3/15/1579, exclusivity from 23 Jun 2022 |
Kite Pharma EU B.V. | 23 Jun 2032 |
| Xenpozyme Olipudase alfa · EU/1/22/1659 |
Treatment of Niemann-Pick disease Designation EU/3/01/056, exclusivity from 27 Jun 2022 |
Sanofi B.V. | 27 Jun 2032 |
| Kinpeygo Budesonide · EU/1/22/1657 |
Treatment of primary IgA nephropathy Designation EU/3/16/1778, exclusivity from 18 Jul 2022 |
STADA Arzneimittel AG | 18 Jul 2032 |
| CRYSVITA Burosumab · EU/1/17/1262 |
Treatment of phosphaturic mesenchymal tumour Designation EU/3/18/2011, exclusivity from 28 Jul 2022 |
Kyowa Kirin Holdings B.V. | 28 Jul 2032 |
| Hepcludex Bulevirtide · EU/1/20/1446 |
Treatment of hepatitis delta virus infection Designation EU/3/15/1500, exclusivity from 5 Aug 2020 |
Gilead Sciences Ireland Unlimited Company | 5 Aug 2032 incl. 24 months paediatric extension |
| Vyvgart Efgartigimod alfa · EU/1/22/1674 |
Treatment of myasthenia gravis Designation EU/3/18/1992, exclusivity from 11 Aug 2022 |
Argenx | 11 Aug 2032 |
| Roctavian Valoctocogene roxaparvovec · EU/1/22/1668 |
Treatment of haemophilia A Designation EU/3/16/1622, exclusivity from 25 Aug 2022 |
BioMarin International Limited | 25 Aug 2032 |
| Scemblix Asciminib · EU/1/22/1670 |
Treatment of chronic myeloid leukaemia Designation EU/3/20/2261, exclusivity from 26 Aug 2022 |
Novartis Europharm Limited | 26 Aug 2032 |
| Imcivree Setmelanotide · EU/1/21/1564 |
Treatment of Bardet-Biedl syndrome Designation EU/3/19/2192, exclusivity from 5 Sep 2022 |
Rhythm Pharmaceuticals Netherlands B.V. | 5 Sep 2032 |
| Tecartus Brexucabtagene autoleucel · EU/1/20/1492 |
Treatment of acute lymphoblastic leukaemia Designation EU/3/20/2344, exclusivity from 5 Sep 2022 |
Kite Pharma EU B.V. | 5 Sep 2032 |
| Amvuttra Vutrisiran · EU/1/22/1681 |
Treatment of transthyretin-mediated amyloidosis Designation EU/3/18/2026, exclusivity from 16 Sep 2022 |
Alnylam Netherlands B.V. | 16 Sep 2032 |
| LIVTENCITY Maribavir · EU/1/22/1672 |
Prevention of cytomegalovirus (CMV) disease in patients with impaired cell mediated immunity deemed at risk Designation EU/3/07/519, exclusivity from 10 Nov 2022 |
Takeda Pharmaceuticals International AG Ireland Branch | 10 Nov 2032 |
| LIVTENCITY Maribavir · EU/1/22/1672 |
Treatment of cytomegalovirus disease in patients with impaired cell mediated immunity Designation EU/3/13/1133, exclusivity from 10 Nov 2022 |
Takeda Pharmaceuticals International AG Ireland Branch | 10 Nov 2032 |
| Pyrukynd Mitapivat · EU/1/22/1662 |
Treatment of pyruvate kinase deficiency Designation EU/3/20/2270, exclusivity from 10 Nov 2022 |
Agios Netherlands B.V. | 10 Nov 2032 |
| Enjaymo Sutimlimab · EU/1/22/1687 |
Treatment of autoimmune haemolytic anaemia Designation EU/3/16/1609, exclusivity from 23 Nov 2022 |
Recordati Rare Diseases | 23 Nov 2032 |
| Ebvallo Tabelecleucel · EU/1/22/1700 |
Treatment of post-transplant lymphoproliferative disorder Designation EU/3/16/1627, exclusivity from 16 Dec 2022 |
Pierre Fabre Medicament | 16 Dec 2032 |
| Fintepla Fenfluramine · EU/1/20/1491 |
Treatment of Lennox-Gastaut syndrome Designation EU/3/17/1836, exclusivity from 31 Jan 2023 |
UCB Pharma | 31 Jan 2033 |
| Hemgenix Etranacogene dezaparvovec · EU/1/22/1715 |
Treatment of haemophilia B Designation EU/3/18/1999, exclusivity from 23 Feb 2023 |
CSL Behring GmbH | 23 Feb 2033 |
| Tibsovo Ivosidenib · EU/1/23/1728 |
Treatment of acute myeloid leukaemia Designation EU/3/16/1802, exclusivity from 8 May 2023 |
Les Laboratoires Servier | 8 May 2033 |
| Tibsovo Ivosidenib · EU/1/23/1728 |
Treatment of biliary tract cancer Designation EU/3/18/1994, exclusivity from 8 May 2023 |
Les Laboratoires Servier | 8 May 2033 |
| Hyftor Sirolimus · EU/1/23/1723 |
Treatment of tuberous sclerosis Designation EU/3/17/1910, exclusivity from 26 May 2023 |
Plusultra Pharma GmbH | 26 May 2033 |
| Koselugo Selumetinib · EU/1/21/1552 |
Treatment of neurofibromatosis type 1 Designation EU/3/18/2050, exclusivity from 19 Jun 2021 |
AstraZeneca AB | 19 Jun 2033 incl. 24 months paediatric extension |
| Bylvay Odevixibat · EU/1/21/1566 |
Treatment of progressive familial intrahepatic cholestasis Designation EU/3/12/1028, exclusivity from 19 Jul 2021 |
Ipsen Pharma | 19 Jul 2033 incl. 24 months paediatric extension |
| ZTALMY Ganaxolone · EU/1/23/1743 |
Treatment of CDKL5 deficiency disorder Designation EU/3/19/2224, exclusivity from 28 Jul 2023 |
Immedica Pharma AB | 28 Jul 2033 |
| TALVEY Talquetamab · EU/1/23/1748 |
Treatment of multiple myeloma Designation EU/3/21/2486, exclusivity from 22 Aug 2023 |
Janssen-Cilag International N.V. | 22 Aug 2033 |
| Voxzogo Vosoritide · EU/1/21/1577 |
Treatment of achondroplasia Designation EU/3/12/1094, exclusivity from 1 Sep 2021 |
BioMarin International Limited | 1 Sep 2033 incl. 24 months paediatric extension |
| Yorvipath Palopegteriparatide · EU/1/23/1766 |
Treatment of hypoparathyroidism Designation EU/3/20/2350, exclusivity from 20 Nov 2023 |
Ascendis Pharma Bone Diseases A/S | 20 Nov 2033 |
| Artesunate Amivas Artesunate · EU/1/21/1582 |
Treatment of malaria Designation EU/3/20/2251, exclusivity from 24 Nov 2021 |
Amivas Ireland Limited | 24 Nov 2033 incl. 24 months paediatric extension |
| AGAMREE Vamorolone · EU/1/23/1776 |
Treatment of Duchenne muscular dystrophy Designation EU/3/14/1309, exclusivity from 15 Dec 2023 |
Santhera Pharmaceuticals (Deutschland) GmbH | 15 Dec 2033 |
| Loargys Pegzilarginase · EU/1/23/1774 |
Treatment of hyperargininaemia Designation EU/3/16/1701, exclusivity from 18 Dec 2023 |
Immedica Pharma AB | 18 Dec 2033 |
| Rezzayo Rezafungin · EU/1/23/1775 |
Treatment of invasive candidiasis Designation EU/3/20/2385, exclusivity from 22 Dec 2023 |
Mundipharma GmbH | 22 Dec 2033 |
| Rystiggo Rozanolixizumab · EU/1/23/1780 |
Treatment of myasthenia gravis Designation EU/3/20/2272, exclusivity from 8 Jan 2024 |
UCB Pharma | 8 Jan 2034 |
| Voraxaze Glucarpidase · EU/1/21/1586 |
Adjunctive treatment in patients at risk of methotrexate toxicity Designation EU/3/02/128, exclusivity from 13 Jan 2022 |
Serb | 13 Jan 2034 incl. 24 months paediatric extension |
| Omjjara Momelotinib · EU/1/23/1782 |
Treatment of post-polycythaemia vera myelofibrosis Designation EU/3/11/886, exclusivity from 26 Jan 2024 |
GlaxoSmithKline Trading Services Limited | 26 Jan 2034 |
| Omjjara Momelotinib · EU/1/23/1782 |
Treatment of post-essential thrombocythaemia myelofibrosis Designation EU/3/11/887, exclusivity from 26 Jan 2024 |
GlaxoSmithKline Trading Services Limited | 26 Jan 2034 |
| Omjjara Momelotinib · EU/1/23/1782 |
Treatment of primary myelofibrosis Designation EU/3/11/888, exclusivity from 26 Jan 2024 |
GlaxoSmithKline Trading Services Limited | 26 Jan 2034 |
| Skyclarys Omaveloxolone · EU/1/23/1786 |
Treatment of Friedreich's ataxia Designation EU/3/18/2037, exclusivity from 12 Feb 2024 |
Biogen Netherlands B.V. | 12 Feb 2034 |
| Casgevy Exagamglogene autotemcel · EU/1/23/1787 |
Treatment of beta-thalassaemia intermedia and major Designation EU/3/19/2210, exclusivity from 12 Feb 2024 |
Vertex Pharmaceuticals (Ireland) Limited | 12 Feb 2034 |
| Casgevy Exagamglogene autotemcel · EU/1/23/1787 |
Treatment of sickle cell disease Designation EU/3/19/2242, exclusivity from 12 Feb 2024 |
Vertex Pharmaceuticals (Ireland) Limited | 12 Feb 2034 |
| Filspari Sparsentan · EU/1/23/1788 |
Treatment of primary IgA nephropathy Designation EU/3/20/2345, exclusivity from 23 Apr 2024 |
Vifor France S.A. | 23 Apr 2034 |
| ZYNYZ Retifanlimab · EU/1/24/1800 |
Treatment of Merkel cell carcinoma Designation EU/3/22/2743, exclusivity from 24 Apr 2024 |
Incyte Biosciences Distribution B.V. | 24 Apr 2034 |
| Voydeya Danicopan · EU/1/24/1792 |
Treatment of paroxysmal nocturnal haemoglobinuria Designation EU/3/17/1946, exclusivity from 25 Apr 2024 |
Alexion Europe SAS | 25 Apr 2034 |
| FABHALTA Iptacopan · EU/1/24/1802 |
Treatment of paroxysmal nocturnal haemoglobinuria Designation EU/3/20/2281, exclusivity from 21 May 2024 |
Novartis Europharm Limited | 21 May 2034 |
| Qalsody Tofersen · EU/1/23/1783 |
Treatment of amyotrophic lateral sclerosis Designation EU/3/16/1732, exclusivity from 3 Jun 2024 |
Biogen Netherlands B.V. | 3 Jun 2034 |
| Filsuvez Birch bark extract · EU/1/22/1652 |
Treatment of epidermolysis bullosa Designation EU/3/10/845, exclusivity from 23 Jun 2022 |
Chiesi Farmaceutici S.p.A. | 23 Jun 2034 incl. 24 months paediatric extension |
| Zokinvy Lonafarnib · EU/1/22/1660 |
Treatment of Hutchinson-Gilford progeria syndrome Designation EU/3/18/2118, exclusivity from 19 Jul 2022 |
Integral Pharma Solutions EU Limited | 19 Jul 2034 incl. 24 months paediatric extension |
| Upstaza Eladocagene exuparvovec · EU/1/22/1653 |
Treatment of aromatic L-amino acid decarboxylase deficiency Designation EU/3/16/1786, exclusivity from 22 Jul 2022 |
PTC Therapeutics International Limited | 22 Jul 2034 incl. 24 months paediatric extension |
| AKANTIOR Polihexanide · EU/1/24/1840 |
Treatment of Acanthamoeba keratitis Designation EU/3/07/498, exclusivity from 23 Aug 2024 |
S.I.F.I. Società Industria Farmaceutica Italiana S.p.A. | 23 Aug 2034 |
| Winrevair Sotatercept · EU/1/24/1850 |
Treatment of pulmonary arterial hypertension Designation EU/3/20/2369, exclusivity from 27 Aug 2024 |
Merck Sharp & Dohme B.V. | 27 Aug 2034 |
| NULIBRY Fosdenopterin · EU/1/22/1684 |
Treatment of molybdenum cofactor deficiency type A Designation EU/3/10/777, exclusivity from 16 Sep 2022 |
Integral Pharma Solutions EU Limited | 16 Sep 2034 incl. 24 months paediatric extension |
| Iqirvo Elafibranor · EU/1/24/1855 |
Treatment of primary biliary cholangitis Designation EU/3/19/2182, exclusivity from 23 Sep 2024 |
Ipsen Pharma | 23 Sep 2034 |
| Vyloy Zolbetuximab · EU/1/24/1856 |
Treatment of gastric cancer Designation EU/3/10/803, exclusivity from 25 Sep 2024 |
Astellas Pharma Europe B.V. | 25 Sep 2034 |
| ELAHERE Mirvetuximab soravtansine · EU/1/24/1866 |
Treatment of ovarian cancer Designation EU/3/15/1458, exclusivity from 15 Nov 2024 |
AbbVie Deutschland GmbH & Co. KG | 15 Nov 2034 |
| Livmarli Maralixibat · EU/1/22/1704 |
Treatment of Alagille syndrome Designation EU/3/13/1214, exclusivity from 12 Dec 2022 |
Mirum Pharmaceuticals International B.V. | 12 Dec 2034 incl. 24 months paediatric extension |
| Emcitate Tiratricol · EU/1/24/1897 |
Treatment of Allan-Herndon-Dudley syndrome Designation EU/3/17/1945, exclusivity from 17 Feb 2025 |
Rare Thyroid Therapeutics International AB | 17 Feb 2035 |
| Lyvdelzi Seladelpar · EU/1/24/1898 |
Treatment of primary biliary cholangitis Designation EU/3/17/1930, exclusivity from 21 Feb 2025 |
Gilead Sciences Ireland UC | 21 Feb 2035 |
| Rytelo Imetelstat · EU/1/24/1894 |
Treatment of myelodysplastic syndromes Designation EU/3/20/2305, exclusivity from 11 Mar 2025 |
Geron Netherlands B.V. | 11 Mar 2035 |
| FABHALTA Iptacopan · EU/1/24/1802 |
Treatment of C3 glomerulopathy Designation EU/3/18/2104, exclusivity from 1 Apr 2025 |
Novartis Europharm Limited | 1 Apr 2035 |
| Vyjuvek Beremagene geperpavec · EU/1/25/1918 |
Treatment of epidermolysis bullosa Designation EU/3/18/2012, exclusivity from 24 Apr 2025 |
Krystal Biotech Netherlands B.V. | 24 Apr 2035 |
| DUVYZAT Givinostat · EU/1/25/1930 |
Treatment of Duchenne muscular dystrophy Designation EU/3/12/1009, exclusivity from 6 Jun 2025 |
Italfarmaco S.p.A. | 6 Jun 2035 |
| Vyvgart Efgartigimod alfa · EU/1/22/1674 |
Treatment of chronic inflammatory demyelinating polyneuropathy Designation EU/3/21/2555, exclusivity from 20 Jun 2025 |
Argenx | 20 Jun 2035 |
| Sephience Sepiapterin · EU/1/25/1939 |
Treatment of hyperphenylalaninemia Designation EU/3/21/2435, exclusivity from 25 Jun 2025 |
PTC Therapeutics International Limited | 25 Jun 2035 |
| Ziihera Zanidatamab · EU/1/25/1931 |
Treatment of biliary tract cancer Designation EU/3/21/2458, exclusivity from 30 Jun 2025 |
Jazz Pharmaceuticals Ireland Limited | 30 Jun 2035 |
| Alyftrek | Treatment of cystic fibrosis Designation EU/3/21/2527, exclusivity from 1 Jul 2025 |
Vertex Pharmaceuticals (Ireland) Limited | 1 Jul 2035 |
| Ezmekly Mirdametinib · EU/1/25/1950 |
Treatment of neurofibromatosis type 1 Designation EU/3/19/2184, exclusivity from 18 Jul 2025 |
Merck Europe B.V. | 18 Jul 2035 |
| Maapliv Amino acids · EU/1/25/1955 |
Treatment of maple syrup urine disease Designation EU/3/18/2076, exclusivity from 29 Jul 2025 |
Recordati Rare Diseases | 29 Jul 2035 |
| Ogsiveo Nirogacestat · EU/1/25/1932 |
Treatment of soft tissue sarcoma Designation EU/3/19/2214, exclusivity from 18 Aug 2025 |
Merck Europe B.V. | 18 Aug 2035 |
| Zemcelpro Haematopoietic stem cells and blood progenitors umbilical cord-derived expanded… · EU/1/25/1960 |
Treatment in haematopoietic stem cell transplantation Designation EU/3/20/2271, exclusivity from 26 Aug 2025 |
Cordex Biologics International Limited | 26 Aug 2035 |
| Ekterly Sebetralstat · EU/1/25/1975 |
Treatment of hereditary angioedema Designation EU/3/22/2625, exclusivity from 18 Sep 2025 |
Kalvista Pharmaceuticals (Ireland) Limited | 18 Sep 2035 |
| Tryngolza Olezarsen · EU/1/25/1969 |
Treatment of familial chylomicronemia syndrome Designation EU/3/24/2973, exclusivity from 18 Sep 2025 |
Swedish Orphan Biovitrum AB (publ) | 18 Sep 2035 |
| Voranigo Vorasidenib · EU/1/25/1912 |
Treatment of glioma Designation EU/3/22/2737, exclusivity from 19 Sep 2025 |
Les Laboratoires Servier | 19 Sep 2035 |
| ROMVIMZA Vimseltinib · EU/1/25/1968 |
Treatment of tenosynovial giant cell tumour, localised and diffuse type Designation EU/3/19/2227, exclusivity from 24 Sep 2025 |
Deciphera Pharmaceuticals (Netherlands) B.V. | 24 Sep 2035 |
| Finlee Dabrafenib · EU/1/23/1767 |
Treatment of glioma Designation EU/3/20/2372, exclusivity from 16 Nov 2023 |
Novartis Europharm Limited | 16 Nov 2035 incl. 24 months paediatric extension |
| Minjuvi Tafasitamab · EU/1/21/1570 |
Treatment of follicular lymphoma Designation EU/3/25/3027, exclusivity from 16 Dec 2025 |
Incyte Biosciences Distribution B.V. | 16 Dec 2035 |
| WAYRILZ Rilzabrutinib · EU/1/25/1974 |
Treatment of immune thrombocytopenia Designation EU/3/20/2278, exclusivity from 23 Dec 2025 |
Sanofi B.V. | 23 Dec 2035 |
| Spexotras Trametinib · EU/1/23/1781 |
Treatment of glioma Designation EU/3/20/2374, exclusivity from 8 Jan 2024 |
Novartis Europharm Limited | 8 Jan 2036 incl. 24 months paediatric extension |
| Waskyra Etuvetidigene autotemcel · EU/1/25/1996 |
Treatment of Wiskott-Aldrich syndrome Designation EU/3/12/998, exclusivity from 12 Jan 2026 |
Fondazione Telethon Ets | 12 Jan 2036 |
| ASPAVELI Pegcetacoplan · EU/1/21/1595 |
Treatment of C3 glomerulopathy with or without immune complexes Designation EU/3/22/2716, exclusivity from 16 Jan 2026 |
Swedish Orphan Biovitrum AB (publ) | 16 Jan 2036 |
| Aqneursa L acetylleucine · EU/1/25/1928 |
Treatment of Niemann-Pick disease Designation EU/3/17/1848, exclusivity from 20 Jan 2026 |
IntraBio Ireland Ltd | 20 Jan 2036 |
| ZYNYZ Retifanlimab · EU/1/24/1800 |
Treatment of anal cancer Designation EU/3/20/2343, exclusivity from 6 Mar 2026 |
Incyte Biosciences Distribution B.V. | 6 Mar 2036 |
| REZUROCK Belumosudil · EU/1/26/2015 |
Treatment of graft-versus-host disease Designation EU/3/19/2205, exclusivity from 25 Mar 2026 |
Sanofi Winthrop Industrie | 25 Mar 2036 |
| Ojemda Tovorafenib · EU/1/26/2025 |
Treatment of glioma Designation EU/3/21/2434, exclusivity from 21 Apr 2026 |
Ipsen Pharma | 21 Apr 2036 |
| Palsonify Paltusotine · EU/1/26/2021 |
Treatment of acromegaly Designation EU/3/25/3035, exclusivity from 27 Apr 2026 |
Crinetics Pharmaceuticals Europe GmbH | 27 Apr 2036 |
| Xolremdi Mavorixafor · EU/1/26/2017 |
Treatment of WHIM syndrome Designation EU/3/19/2183, exclusivity from 28 Apr 2026 |
Norgine B.V. | 28 Apr 2036 |
| Imcivree Setmelanotide · EU/1/21/1564 |
Treatment of acquired hypothalamic obesity Designation EU/3/23/2833, exclusivity from 5 May 2026 |
Rhythm Pharmaceuticals Netherlands B.V. | 5 May 2036 |
| Pyrukynd Mitapivat · EU/1/22/1662 |
Treatment of thalassaemia intermedia and major (initially named treatment of beta-thalassaemia intermedia and major) Designation EU/3/23/2827, exclusivity from 22 May 2026 |
Agios Netherlands B.V. | 22 May 2036 |
| Pyrukynd Mitapivat · EU/1/22/1662 |
Treatment of thalassaemia intermedia and major (initially named treatment of beta-thalassaemia intermedia and major) Designation EU/3/23/2889, exclusivity from 22 May 2026 |
Agios Netherlands B.V. | 22 May 2036 |
| Joenja Leniolisib · EU/1/26/2034 |
Treatment of activated phosphoinositide 3-kinase delta syndrome Designation EU/3/20/2339, exclusivity from 22 May 2026 |
Pharming Technologies B.V. | 22 May 2036 |
| IMDYLLTRA Tarlatamab · EU/1/26/2033 |
Treatment of pulmonary neuroendocrine carcinoma (initially named treatment of small cell lung cancer) Designation EU/3/23/2876, exclusivity from 1 Jun 2026 |
Amgen Europe B.V. | 1 Jun 2036 |
| ALTUVOCT Efanesoctocog alfa · EU/1/24/1824 |
Treatment of haemophilia A Designation EU/3/19/2176, exclusivity from 18 Jun 2024 |
Swedish Orphan Biovitrum AB (publ) | 18 Jun 2036 incl. 24 months paediatric extension |
| Redemplo Plozasiran · EU/1/26/2041 |
Treatment of familial chylomicronaemia syndrome Designation EU/3/21/2459, exclusivity from 22 Jun 2026 |
Arrowhead Pharmaceuticals Ireland Limited | 22 Jun 2036 |
| Livmarli Maralixibat · EU/1/22/1704 |
Treatment of progressive familial intrahepatic cholestasis Designation EU/3/13/1216, exclusivity from 1 Jul 2024 |
Mirum Pharmaceuticals International B.V. | 1 Jul 2036 incl. 24 months paediatric extension |
| Vijoice Alpelisib · EU/1/26/2042 |
Treatment of PIK3CA related overgrowth spectrum Designation EU/3/21/2420, exclusivity from 16 Jul 2026 |
Novartis Europharm Limited | 16 Jul 2036 |
| ADZYNMA Radamts13 · EU/1/24/1837 |
Treatment of thrombotic thrombocytopenic purpura Designation EU/3/08/588, exclusivity from 2 Aug 2024 |
Takeda Manufacturing Austria AG | 2 Aug 2036 incl. 24 months paediatric extension |
| KYGEVVI Thymidine and deoxycytidine · EU/1/25/2013 |
Treatment of mitochondrial DNA depletion syndrome, myopathic form Designation EU/3/17/1870, exclusivity from 27 Mar 2026 |
UCB Pharma | 27 Mar 2038 incl. 24 months paediatric extension |
| Daybu Trofinetide · EU/1/26/2045 |
Treatment of Rett syndrome Designation EU/3/15/1534, exclusivity from 21 Aug 2026 |
Acadia Pharmaceuticals (Netherlands) B.V. | 21 Aug 2038 incl. 24 months paediatric extension |
| Nezglyal Leriglitazone · EU/1/26/2060 |
Treatment of adrenoleukodystrophy Designation EU/3/16/1770, exclusivity from 22 Sep 2026 |
Minoryx Therapeutics S.L. | 22 Sep 2038 incl. 24 months paediatric extension |
EU orphan market exclusivity runs 10 years from authorisation for the orphan condition, extended by 2 years when paediatric study requirements are met. The end date is calculated exactly as the European Commission's Union Register displays it; each medicine links to its register page.
Important. Patent and exclusivity information is reproduced from the FDA Orange Book and Purple Book and the European Commission's Union Register as of the date above. Listed patents and expiry dates are as submitted to, or published by, the regulator and may not reflect litigation, invalidation, terminal disclaimers, lapsed renewal fees, settlements or later extensions. Supplementary protection certificates in EU countries are not covered. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
How this page is built
Every date is copied from the regulators' registers. The only calculation is the EU orphan end date, done exactly as the Commission's own register page does it (start date plus 10 years, plus any paediatric extension).
- FDA Orange Book data files ↗ patent numbers, patent expiry dates (including extensions and paediatric exclusivity), drug substance and product flags, exclusivity codes and dates for every NDA product
- FDA Orange Book exclusivity code definitions ↗ the meaning of each exclusivity code shown
- FDA Purple Book data download ↗ reference product and orphan exclusivity expiry dates for licensed biologics
- European Commission, Union Register of medicinal products ↗ orphan designations linked to authorised medicines and their orphan market exclusivity (CC BY 4.0)
A job downloads the Orange Book data files monthly, the Purple Book monthly file, and the Union Register orphan links weekly. For each substance it keeps unexpired listed patents and exclusivities and shows the latest. No AI drafting and no editorial pass. See our editorial standards. The the regulators data on this page was last retrieved on 12 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.
Please verify before you rely on this.
This page is general information for life-science and pharmaceutical professionals. It is
not medical advice, and it has not been reviewed by a clinician — our editorial
team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most
recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC)
and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not
automatically interchangeable, and approvals, brand names and indications differ between the US, the
EU/Ireland (EMA/HPRA) and other regions.
Spotted an error? Tell us — we correct promptly and log it.