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Last Updated: September 25, 2022

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 two patents protecting this drug.

This drug has ninety-nine patent family members in thirty-seven 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 will be eligible for patent challenges on April 17, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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

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Summary for PEMAZYRE
International Patents:99
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 27
Clinical Trials: 3
Patent Applications: 61
Drug Prices: Drug price information for PEMAZYRE
What excipients (inactive ingredients) are in PEMAZYRE?PEMAZYRE excipients list
DailyMed Link:PEMAZYRE at DailyMed
Drug patent expirations by year for PEMAZYRE
Drug Prices for PEMAZYRE

See drug prices for PEMAZYRE

DrugPatentWatch® Estimated Generic Entry Opportunity 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

SponsorPhase
The First Affiliated Hospital of Xiamen UniversityPhase 2
Academic and Community Cancer Research UnitedPhase 1
National Cancer Institute (NCI)Phase 1

See all PEMAZYRE clinical trials

US Patents and Regulatory Information for PEMAZYRE

PEMAZYRE is protected by two US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PEMAZYRE is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Substituted tricyclic compounds as FGFR inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting PEMAZYRE

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

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 213736-001 Apr 17, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Incyte Corp PEMAZYRE pemigatinib TABLET;ORAL 213736-002 Apr 17, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Incyte Corp PEMAZYRE pemigatinib TABLET;ORAL 213736-001 Apr 17, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Patent: 7823
Estimated Expiration: See Plans and Pricing

Australia

Patent: 13287176
Estimated Expiration: See Plans and Pricing

Patent: 19200066
Estimated Expiration: See Plans and Pricing

Patent: 20270520
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2014030812
Estimated Expiration: See Plans and Pricing

Canada

Patent: 76689
Estimated Expiration: See Plans and Pricing

Patent: 49881
Estimated Expiration: See Plans and Pricing

Chile

Patent: 14003355
Estimated Expiration: See Plans and Pricing

Patent: 17001984
Estimated Expiration: See Plans and Pricing

China

Patent: 4507943
Estimated Expiration: See Plans and Pricing

Patent: 7383009
Estimated Expiration: See Plans and Pricing

Patent: 7652289
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 40375
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 140577
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0170430
Estimated Expiration: See Plans and Pricing

Patent: 0190007
Estimated Expiration: See Plans and Pricing

Patent: 0201966
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 18744
Estimated Expiration: See Plans and Pricing

Patent: 21299
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 61595
Estimated Expiration: See Plans and Pricing

Patent: 76170
Estimated Expiration: See Plans and Pricing

Patent: 95367
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 15001225
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 6592
Estimated Expiration: See Plans and Pricing

Patent: 1590005
Estimated Expiration: See Plans and Pricing

Patent: 2091923
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 61595
Estimated Expiration: See Plans and Pricing

Patent: 76170
Estimated Expiration: See Plans and Pricing

Patent: 95367
Estimated Expiration: See Plans and Pricing

Patent: 22273
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 12326
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 31916
Estimated Expiration: See Plans and Pricing

Patent: 42374
Estimated Expiration: See Plans and Pricing

Patent: 52195
Estimated Expiration: See Plans and Pricing

Patent: 100035
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6078
Estimated Expiration: See Plans and Pricing

Patent: 6976
Estimated Expiration: See Plans and Pricing

Patent: 6433
Estimated Expiration: See Plans and Pricing

Patent: 2622
Estimated Expiration: See Plans and Pricing

Patent: 9834
Estimated Expiration: See Plans and Pricing

Japan

Patent: 01321
Estimated Expiration: See Plans and Pricing

Patent: 36665
Estimated Expiration: See Plans and Pricing

Patent: 45863
Estimated Expiration: See Plans and Pricing

Patent: 11946
Estimated Expiration: See Plans and Pricing

Patent: 15521600
Estimated Expiration: See Plans and Pricing

Patent: 17222709
Estimated Expiration: See Plans and Pricing

Patent: 18135377
Estimated Expiration: See Plans and Pricing

Patent: 19178156
Estimated Expiration: See Plans and Pricing

Patent: 20143142
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 2021519
Estimated Expiration: See Plans and Pricing

Patent: 61595
Estimated Expiration: See Plans and Pricing

Patent: 76170
Estimated Expiration: See Plans and Pricing

Patent: 95367
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 1375
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 9293
Estimated Expiration: See Plans and Pricing

Patent: 14015192
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 651
Estimated Expiration: See Plans and Pricing

Patent: 300
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 1131
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 2747
Estimated Expiration: See Plans and Pricing

Patent: 0134
Estimated Expiration: See Plans and Pricing

Patent: 3274
Estimated Expiration: See Plans and Pricing

Norway

Patent: 21034
Estimated Expiration: See Plans and Pricing

Peru

Patent: 150684
Estimated Expiration: See Plans and Pricing

Patent: 190736
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 014502772
Estimated Expiration: See Plans and Pricing

Patent: 016502133
Estimated Expiration: See Plans and Pricing

Patent: 019502809
Estimated Expiration: See Plans and Pricing

Poland

Patent: 61595
Estimated Expiration: See Plans and Pricing

Patent: 76170
Estimated Expiration: See Plans and Pricing

Patent: 95367
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 61595
Estimated Expiration: See Plans and Pricing

Patent: 76170
Estimated Expiration: See Plans and Pricing

Patent: 95367
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 908
Estimated Expiration: See Plans and Pricing

Patent: 514
Estimated Expiration: See Plans and Pricing

Patent: 089
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201610416T
Estimated Expiration: See Plans and Pricing

Patent: 201408238W
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 61595
Estimated Expiration: See Plans and Pricing

Patent: 76170
Estimated Expiration: See Plans and Pricing

Patent: 95367
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2140426
Estimated Expiration: See Plans and Pricing

Patent: 150036044
Estimated Expiration: See Plans and Pricing

Patent: 200093696
Estimated Expiration: See Plans and Pricing

Spain

Patent: 18003
Estimated Expiration: See Plans and Pricing

Patent: 04744
Estimated Expiration: See Plans and Pricing

Patent: 32497
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 06953
Estimated Expiration: See Plans and Pricing

Patent: 1402574
Estimated Expiration: See Plans and Pricing

Patent: 2124382
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 7347
Estimated Expiration: See Plans and Pricing

Patent: 5503
Estimated Expiration: See Plans and Pricing

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
Israel 289834 המרת תרכובות טריסייקליות כמעכבות fgfr (Substituted tricyclic compounds as fgfr inhibitors) See Plans and Pricing
Lithuania 3176170 See Plans and Pricing
Portugal 3495367 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PEMAZYRE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2861595 C202130046 Spain See Plans and Pricing PRODUCT NAME: PEMIGATINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1535; DATE OF AUTHORISATION: 20210326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU//1/21/1535; DATE OF FIRST AUTHORISATION IN EEA: 20210326
2861595 CA 2021 00033 Denmark See Plans and Pricing PRODUCT NAME: PEMIGATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1535 20210329
2861595 C02861595/01 Switzerland See Plans and Pricing PRODUCT NAME: PEMIGATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68143 13.07.2021
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Dow
Mallinckrodt
Boehringer Ingelheim
Harvard Business School
Johnson and Johnson

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.