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Last Updated: January 27, 2023

Pemigatinib - Generic Drug Details


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What are the generic sources for pemigatinib and what is the scope of freedom to operate?

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

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

One supplier is listed for this compound.

Summary for pemigatinib
International Patents:119
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 28
Clinical Trials: 31
Patent Applications: 194
What excipients (inactive ingredients) are in pemigatinib?pemigatinib excipients list
DailyMed Link:pemigatinib at DailyMed
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 213736-003 Apr 17, 2020 RX Yes Yes 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
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
>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

Supplementary Protection Certificates for pemigatinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2861595 2021C/536 Belgium See Plans and Pricing PRODUCT NAME: PEMIGATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1535 20210329
2861595 301131 Netherlands See Plans and Pricing PRODUCT NAME: PEMIGATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1535 20210329
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 2190036-0 Sweden See Plans and Pricing 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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