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Last Updated: June 21, 2021

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PEMAZYRE Drug 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 seventy-nine patent family members in thirty-four 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:79
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 16
Clinical Trials: 1
Patent Applications: 18
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
Oregon Health and Science UniversityPhase 1
OHSU Knight Cancer InstitutePhase 1
Incyte CorporationPhase 1

See all PEMAZYRE clinical trials

US Patents and Regulatory Information for PEMAZYRE

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   Get Started Free   Get Started Free   Get Started Free
Incyte Corp PEMAZYRE pemigatinib TABLET;ORAL 213736-002 Apr 17, 2020 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Incyte Corp PEMAZYRE pemigatinib TABLET;ORAL 213736-001 Apr 17, 2020 RX Yes No   Get Started Free   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Dow
Mallinckrodt
Boehringer Ingelheim
Harvard Business School
Johnson and Johnson

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