Question 1

Is there a generic for Mavacamten?

Accepted Answer

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

Question 2

What is the reference-listed drug for Mavacamten?

Accepted Answer

CAMZYOS (NDA 214998, BRISTOL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Mavacamten?

Accepted Answer

The Orange Book lists 2 patents against Mavacamten 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 Mavacamten have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 12 marketing-exclusivity periods for Mavacamten. 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 Mavacamten are approved?

Accepted Answer

Mavacamten is approved in the following dosage form: capsule.

Patent	Expires	In	Type
9585883	Jun 19, 2034	in 8 yr 1 mo	U-3373
RE50050	Apr 28, 2036	in 10 yr	SubstanceProduct

Mavacamten

Brand (NDA) products · capsule

Marketing exclusivity (12)

Listed patents (2)

Mavacamten — frequently asked questions

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