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Last Updated: June 14, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 213736


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NDA 213736 describes PEMAZYRE, which is a drug marketed by Incyte Corp and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the PEMAZYRE profile page.

The generic ingredient in PEMAZYRE is pemigatinib. One supplier is listed for this compound. Additional details are available on the pemigatinib profile page.
Summary for 213736
Tradename:PEMAZYRE
Applicant:Incyte Corp
Ingredient:pemigatinib
Patents:2
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 213736
Generic Entry Date for 213736*:
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.

Suppliers and Packaging for NDA: 213736
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PEMAZYRE pemigatinib TABLET;ORAL 213736 NDA Incyte Corporation 50881-026 50881-026-01 14 TABLET in 1 BOTTLE, PLASTIC (50881-026-01)
PEMAZYRE pemigatinib TABLET;ORAL 213736 NDA Incyte Corporation 50881-027 50881-027-01 14 TABLET in 1 BOTTLE, PLASTIC (50881-027-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4.5MG
Approval Date:Apr 17, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 17, 2027
Regulatory Exclusivity Use: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
Regulatory Exclusivity Expiration:Apr 17, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Get Started FreePatent Expiration:Jun 12, 2033Product Flag?Substance Flag?Delist Request?
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

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