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Last Updated: February 29, 2024

Pemigatinib - Generic Drug Details


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What are the generic drug sources for pemigatinib and what is the scope of patent protection?

Pemigatinib is the generic ingredient in one branded drug marketed by Incyte Corp and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pemigatinib has one hundred and thirty-two patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for pemigatinib
International Patents:132
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 36
Clinical Trials: 32
Patent Applications: 184
What excipients (inactive ingredients) are in pemigatinib?pemigatinib excipients list
DailyMed Link:pemigatinib at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for pemigatinib
Generic Entry Date for pemigatinib*:
Constraining patent/regulatory exclusivity:
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 pemigatinib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestPhase 2
Tianjin Medical University Cancer Institute and HospitalPhase 2
Zhejiang Cancer HospitalPhase 2

See all pemigatinib clinical trials

US Patents and Regulatory Information for pemigatinib

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 213736-002 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 213736-002 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
>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 pemigatinib

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 pemigatinib

Country Patent Number Title Estimated Expiration
Malaysia 188363 SUBSTITUTED TRICYCLIC COMPOUNDS AS FGFR INHIBITORS ⤷  Try a Trial
Chile 2017001984 Compuestos tricíclicos sustituidos como inhibidores del receptor del factor de crecimiento de fibroblastos (fgfr).(solicitud divisional 3355-2014) ⤷  Try a Trial
Cyprus 1121299 ⤷  Try a Trial
Denmark 3176170 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for pemigatinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 C202130046 Spain ⤷  Try a Trial 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 2021C/536 Belgium ⤷  Try a Trial PRODUCT NAME: PEMIGATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1535 20210329
2861595 LUC00222 Luxembourg ⤷  Try a Trial PRODUCT NAME: PEMIGATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND 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.