Question 1

Is there a generic for Adagrasib?

Accepted Answer

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

Question 2

What is the reference-listed drug for Adagrasib?

Accepted Answer

KRAZATI (NDA 216340, 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 Adagrasib?

Accepted Answer

The Orange Book lists 4 patents against Adagrasib products, with the earliest listed expiry in 2037. 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 Adagrasib have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Adagrasib. 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 Adagrasib are approved?

Accepted Answer

Adagrasib is approved in the following dosage form: tablet.

Patent	Expires	In	Type
10689377	May 17, 2037	in 11 yr 1 mo	SubstanceProductU-3490
12336995	Feb 05, 2041	in 14 yr 10 mo	U-3953
12281113	Sep 10, 2041	in 15 yr 5 mo	SubstanceProduct
12383503	Aug 21, 2043	in 17 yr 5 mo	Product

Adagrasib

Brand (NDA) products · tablet

Marketing exclusivity (2)

Listed patents (4)

Adagrasib — frequently asked questions

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