Question 1

Is there a generic for Rimegepant sulfate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Rimegepant sulfate?

Accepted Answer

NURTEC ODT (NDA 212728, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Rimegepant sulfate?

Accepted Answer

The Orange Book lists 3 patents against Rimegepant sulfate products, with the earliest listed expiry in 2033. 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

What dosage forms of Rimegepant sulfate are approved?

Accepted Answer

Rimegepant sulfate is approved in the following dosage form: tablet, orally disintegrating.

Patent	Expires	In	Type
8759372	Feb 25, 2033	in 6 yr 9 mo	SubstanceProduct
8314117	Feb 27, 2034	in 7 yr 10 mo	SubstanceProductU-2718
11083724	Mar 25, 2039	in 12 yr 11 mo	ProductU-2718

Rimegepant sulfate

Brand (NDA) products · tablet, orally disintegrating

Listed patents (3)

Rimegepant sulfate — frequently asked questions

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