PEMAZYRE Drug Patent Profile
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Which patents cover Pemazyre, and when can generic versions of Pemazyre launch?
Pemazyre is a drug marketed by Incyte Corp and is included in one NDA. There are four patents protecting this drug.
This drug has one hundred and thirty-four patent family members in thirty-eight countries.
The generic ingredient in PEMAZYRE is pemigatinib. One supplier is listed for this compound. Additional details are available on the pemigatinib profile page.
DrugPatentWatch® Generic Entry Outlook for Pemazyre
Pemazyre was eligible for patent challenges on April 17, 2024.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 30, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for PEMAZYRE
| International Patents: | 134 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 36 |
| Clinical Trials: | 7 |
| Patent Applications: | 76 |
| Drug Prices: | Drug price information for PEMAZYRE |
| What excipients (inactive ingredients) are in PEMAZYRE? | PEMAZYRE excipients list |
| DailyMed Link: | PEMAZYRE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PEMAZYRE
Generic Entry Date for PEMAZYRE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for PEMAZYRE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Phase 2 |
| Incyte Biosciences International Sàrl | Phase 2 |
| Tianjin Medical University Cancer Institute and Hospital | Phase 2 |
Pharmacology for PEMAZYRE
Anatomical Therapeutic Chemical (ATC) Classes for PEMAZYRE
US Patents and Regulatory Information for PEMAZYRE
PEMAZYRE is protected by nine US patents and four FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of PEMAZYRE is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting PEMAZYRE
Substituted tricyclic compounds as FGFR inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING ONCE DAILY A TABLET CONTAINING ABOUT 0.5 MG TO ABOUT 10 MG OF PEMIGATINIB
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING PEMIGATINIB QD FOR 14 DAYS THEN NOT ADMINISTERING PEMIGATINIB FOR 7 DAYS IN A 21-DAY CYCLE
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING PEMIGATINIB IN A DAILY DOSE OF ABOUT 5 MG TO ABOUT 20 MG
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING PEMIGATINIB WHILE AVOIDING THE CONCOMITANT USE OF STRONG AND MODERATE CYP3A INHIBITORS
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING PEMIGATINIB WHILE AVOIDING THE CONCOMITANT USE OF STRONG AND MODERATE CYP3A INDUCERS
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF RELAPSED OR REFRACTORY MYELOID/LYMPHOID NEOPLASMS WITH FGFR1 REARRANGEMENT BY ADMINISTERING PEMIGATINIB WHILE AVOIDING THE CONCOMITANT USE OF STRONG AND MODERATE CYP3A INDUCERS
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF RELAPSED OR REFRACTORY MYELOID/LYMPHOID NEOPLASMS WITH FGFR1 REARRANGEMENT BY ADMINISTERING PEMIGATINIB WHILE AVOIDING THE CONCOMITANT USE OF STRONG AND MODERATE CYP3A INHIBITORS
Substituted tricyclic compounds as FGFR inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting PEMAZYRE
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
INDICATED FOR THE TREATMENT OF ADULTS WITH PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF ADULTS WITH RELAPSED OR REFRACTORY MYELOID/LYMPHOID NEOPLASMS (MLNS) WITH FIBROBLAST GROWTH FACTOR RECEPTOR 1 (FGFR1) REARRANGEMENT
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF ADULTS WITH RELAPSED OR REFRACTORY MYELOID/LYMPHOID NEOPLASMS (MLNS) WITH FIBROBLAST GROWTH FACTOR RECEPTOR 1 (FGFR1) REARRANGEMENT
Exclusivity Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Incyte Corp | PEMAZYRE | pemigatinib | TABLET;ORAL | 213736-003 | Apr 17, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Incyte Corp | PEMAZYRE | pemigatinib | TABLET;ORAL | 213736-001 | Apr 17, 2020 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Incyte Corp | PEMAZYRE | pemigatinib | TABLET;ORAL | 213736-002 | Apr 17, 2020 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Incyte Corp | PEMAZYRE | pemigatinib | TABLET;ORAL | 213736-002 | Apr 17, 2020 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Incyte Corp | PEMAZYRE | pemigatinib | TABLET;ORAL | 213736-003 | Apr 17, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Incyte Corp | PEMAZYRE | pemigatinib | TABLET;ORAL | 213736-003 | Apr 17, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Incyte Corp | PEMAZYRE | pemigatinib | TABLET;ORAL | 213736-001 | Apr 17, 2020 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for PEMAZYRE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Incyte Biosciences Distribution B.V. | Pemazyre | pemigatinib | EMEA/H/C/005266 Pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. |
Authorised | no | no | yes | 2021-03-26 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for PEMAZYRE
When does loss-of-exclusivity occur for PEMAZYRE?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 1424
Estimated Expiration: ⤷ Try a Trial
Patent: 7823
Estimated Expiration: ⤷ Try a Trial
Patent: 2006
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 13287176
Estimated Expiration: ⤷ Try a Trial
Patent: 19200066
Estimated Expiration: ⤷ Try a Trial
Patent: 20270520
Estimated Expiration: ⤷ Try a Trial
Patent: 22291504
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2014030812
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 76689
Estimated Expiration: ⤷ Try a Trial
Patent: 49881
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 14003355
Estimated Expiration: ⤷ Try a Trial
Patent: 17001984
Estimated Expiration: ⤷ Try a Trial
China
Patent: 4507943
Estimated Expiration: ⤷ Try a Trial
Patent: 7383009
Estimated Expiration: ⤷ Try a Trial
Patent: 7652289
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 40375
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 140577
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0170430
Estimated Expiration: ⤷ Try a Trial
Patent: 0190007
Estimated Expiration: ⤷ Try a Trial
Patent: 0201966
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 18744
Estimated Expiration: ⤷ Try a Trial
Patent: 21299
Estimated Expiration: ⤷ Try a Trial
Patent: 23631
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 61595
Estimated Expiration: ⤷ Try a Trial
Patent: 76170
Estimated Expiration: ⤷ Try a Trial
Patent: 95367
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 15001225
Estimated Expiration: ⤷ Try a Trial
Patent: 22091792
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 6592
Estimated Expiration: ⤷ Try a Trial
Patent: 1590005
Estimated Expiration: ⤷ Try a Trial
Patent: 2091923
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 61595
Estimated Expiration: ⤷ Try a Trial
Patent: 76170
Estimated Expiration: ⤷ Try a Trial
Patent: 95367
Estimated Expiration: ⤷ Try a Trial
Patent: 22273
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 12326
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 31916
Estimated Expiration: ⤷ Try a Trial
Patent: 42374
Estimated Expiration: ⤷ Try a Trial
Patent: 52195
Estimated Expiration: ⤷ Try a Trial
Patent: 100035
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 6078
Estimated Expiration: ⤷ Try a Trial
Patent: 6976
Estimated Expiration: ⤷ Try a Trial
Patent: 6433
Estimated Expiration: ⤷ Try a Trial
Patent: 2622
Estimated Expiration: ⤷ Try a Trial
Patent: 9834
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 01321
Estimated Expiration: ⤷ Try a Trial
Patent: 36665
Estimated Expiration: ⤷ Try a Trial
Patent: 45863
Estimated Expiration: ⤷ Try a Trial
Patent: 11946
Estimated Expiration: ⤷ Try a Trial
Patent: 00170
Estimated Expiration: ⤷ Try a Trial
Patent: 92096
Estimated Expiration: ⤷ Try a Trial
Patent: 15521600
Estimated Expiration: ⤷ Try a Trial
Patent: 17222709
Estimated Expiration: ⤷ Try a Trial
Patent: 18135377
Estimated Expiration: ⤷ Try a Trial
Patent: 19178156
Estimated Expiration: ⤷ Try a Trial
Patent: 20143142
Estimated Expiration: ⤷ Try a Trial
Patent: 23027344
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 861595
Estimated Expiration: ⤷ Try a Trial
Patent: 2021519
Estimated Expiration: ⤷ Try a Trial
Patent: 61595
Estimated Expiration: ⤷ Try a Trial
Patent: 76170
Estimated Expiration: ⤷ Try a Trial
Patent: 95367
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 1375
Estimated Expiration: ⤷ Try a Trial
Patent: 8363
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 9293
Estimated Expiration: ⤷ Try a Trial
Patent: 14015192
Estimated Expiration: ⤷ Try a Trial
Patent: 22000517
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 651
Estimated Expiration: ⤷ Try a Trial
Patent: 300
Estimated Expiration: ⤷ Try a Trial
Netherlands
Patent: 1131
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 2747
Estimated Expiration: ⤷ Try a Trial
Patent: 0134
Estimated Expiration: ⤷ Try a Trial
Patent: 3274
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 21034
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 150684
Estimated Expiration: ⤷ Try a Trial
Patent: 190736
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 014502772
Estimated Expiration: ⤷ Try a Trial
Patent: 016502133
Estimated Expiration: ⤷ Try a Trial
Patent: 019502809
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 61595
Estimated Expiration: ⤷ Try a Trial
Patent: 76170
Estimated Expiration: ⤷ Try a Trial
Patent: 95367
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 61595
Estimated Expiration: ⤷ Try a Trial
Patent: 76170
Estimated Expiration: ⤷ Try a Trial
Patent: 95367
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 908
Estimated Expiration: ⤷ Try a Trial
Patent: 514
Estimated Expiration: ⤷ Try a Trial
Patent: 089
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201610416T
Estimated Expiration: ⤷ Try a Trial
Patent: 201408238W
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 61595
Estimated Expiration: ⤷ Try a Trial
Patent: 76170
Estimated Expiration: ⤷ Try a Trial
Patent: 95367
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2140426
Estimated Expiration: ⤷ Try a Trial
Patent: 2406771
Estimated Expiration: ⤷ Try a Trial
Patent: 2556118
Estimated Expiration: ⤷ Try a Trial
Patent: 150036044
Estimated Expiration: ⤷ Try a Trial
Patent: 200093696
Estimated Expiration: ⤷ Try a Trial
Patent: 220080213
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 18003
Estimated Expiration: ⤷ Try a Trial
Patent: 04744
Estimated Expiration: ⤷ Try a Trial
Patent: 32497
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 06953
Estimated Expiration: ⤷ Try a Trial
Patent: 69529
Estimated Expiration: ⤷ Try a Trial
Patent: 01156
Estimated Expiration: ⤷ Try a Trial
Patent: 1402574
Estimated Expiration: ⤷ Try a Trial
Patent: 2124382
Estimated Expiration: ⤷ Try a Trial
Patent: 2241898
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 7347
Estimated Expiration: ⤷ Try a Trial
Patent: 5503
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering PEMAZYRE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2832497 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2014007951 | ⤷ Try a Trial | |
| Philippines | 12014502772 | SUBSTITUTED TRICYCLIC COMPOUNDS AS FGFR INHIBITORS | ⤷ Try a Trial |
| Morocco | 52494 | FORMES SOLIDES D'UN INHIBITEUR DE FGFR ET LEURS PROCÉDÉS DE PRÉPARATION | ⤷ Try a Trial |
| South Korea | 20200093696 | FGFR 억제제로서 치환된 트리사이클릭 화합물 (FGFR SUBSTITUTED TRICYCLIC COMPOUNDS AS FGFR INHIBITORS) | ⤷ Try a Trial |
| Taiwan | 201402574 | Substituted tricyclic compounds as FGFR inhibitors | ⤷ Try a Trial |
| Costa Rica | 20140577 | COMPUESTOS TRICICLICOS SUSTITUIDOS COMO INHIBIDORES DEL RECEPTOR DEL FACTOR DE CRECIMIENTO DE FIBROBLASTOS (FGFR) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PEMAZYRE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2861595 | CR 2021 00033 | Denmark | ⤷ Try a Trial | PRODUCT NAME: PEMIGATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1535 20210329 |
| 2861595 | C02861595/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: PEMIGATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68143 13.07.2021 |
| 2861595 | C20210023 00404 | Estonia | ⤷ Try a Trial | PRODUCT NAME: PEMIGATINIIB;REG NO/DATE: EU/1/21/1535 29.03.2021 |
| 2861595 | 301131 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: PEMIGATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1535 20210329 |
| 2861595 | CA 2021 00033 | Denmark | ⤷ Try a Trial | PRODUCT NAME: PEMIGATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1535 20210329 |
| 2861595 | SPC/GB21/052 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: PEMIGATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/21/1535(FOR NI) 20210329; UK FURTHER MA ON IPSUM 20210329 |
| 2861595 | 2190036-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: PEMIGATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1535 20210329 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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