Question 1

Is there a generic for Zavegepant hydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Zavegepant hydrochloride?

Accepted Answer

ZAVZPRET (NDA 216386, 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 Zavegepant hydrochloride?

Accepted Answer

The Orange Book lists 1 patent against Zavegepant hydrochloride 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 Zavegepant hydrochloride have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Zavegepant hydrochloride is approved in the following dosage form: spray, metered.

Zavegepant hydrochloride

Brand (NDA) products · spray, metered

Marketing exclusivity (1)

Listed patents (1)

Zavegepant hydrochloride — frequently asked questions

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