Question 1

Is there a generic for Vibegron?

Accepted Answer

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

Question 2

What is the reference-listed drug for Vibegron?

Accepted Answer

GEMTESA (NDA 213006, SUMITOMO PHARMA AM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Vibegron?

Accepted Answer

The Orange Book lists 5 patents against Vibegron products, with the earliest listed expiry in 2029. 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 Vibegron have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Vibegron. 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 Vibegron are approved?

Accepted Answer

Vibegron is approved in the following dosage form: tablet.

Patent	Expires	In	Type
8653260	Apr 02, 2029	in 2 yr 10 mo	Substance
12180219	Mar 12, 2034	in 7 yr 10 mo	SubstanceProduct
8247415	Dec 23, 2034	in 8 yr 8 mo	SubstanceProductU-4219
12102638	Mar 22, 2040	in 14 yr	U-3045
12357636	Jul 06, 2042	in 16 yr 3 mo	U-4219

Vibegron

Brand (NDA) products · tablet

Marketing exclusivity (1)

Listed patents (5)

Vibegron — frequently asked questions

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