Question 1

Is there a generic for Belzutifan?

Accepted Answer

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

Question 2

What is the reference-listed drug for Belzutifan?

Accepted Answer

WELIREG (NDA 215383, MERCK SHARP DOHME) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Belzutifan?

Accepted Answer

The Orange Book lists 3 patents against Belzutifan 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 Belzutifan have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 4 marketing-exclusivity periods for Belzutifan. 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 Belzutifan are approved?

Accepted Answer

Belzutifan is approved in the following dosage form: tablet.

Patent	Expires	In	Type
RE49948	Sep 05, 2034	in 8 yr 4 mo	SubstanceProductU-4195
9908845	Sep 05, 2034	in 8 yr 4 mo	SubstanceProductU-4195
12358870	Jun 30, 2042	in 16 yr 3 mo	Product

Belzutifan

Brand (NDA) products · tablet

Marketing exclusivity (4)

Listed patents (3)

Belzutifan — frequently asked questions

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