Question 1

Is there a generic for Pemigatinib?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Pemigatinib. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Pemigatinib?

Accepted Answer

PEMAZYRE (NDA 213736, INCYTE CORP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Pemigatinib?

Accepted Answer

The Orange Book lists 5 patents against Pemigatinib products, with the earliest listed expiry in 2034. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Pemigatinib have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 6 marketing-exclusivity periods for Pemigatinib. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Pemigatinib are approved?

Accepted Answer

Pemigatinib is approved in the following dosage form: tablet.

Patent	Expires	In	Type
10131667	Apr 17, 2034	in 7 yr 11 mo	U-2809
9611267	Jan 30, 2035	in 8 yr 9 mo	SubstanceProduct
11466004	May 03, 2039	in 13 yr 1 mo	U-3464
11628162	Aug 30, 2040	in 14 yr 5 mo	U-3568
12552792	Oct 03, 2040	in 14 yr 6 mo	SubstanceProduct

Pemigatinib

Brand (NDA) products · tablet

Marketing exclusivity (6)

Listed patents (5)

Pemigatinib — frequently asked questions

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