Question 1

Is there a generic for Avapritinib?

Accepted Answer

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

Question 2

What is the reference-listed drug for Avapritinib?

Accepted Answer

AYVAKIT (NDA 212608, BLUEPRINT MEDICINES) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Avapritinib?

Accepted Answer

The Orange Book lists 8 patents against Avapritinib 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 Avapritinib have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 16 marketing-exclusivity periods for Avapritinib. 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 Avapritinib are approved?

Accepted Answer

Avapritinib is approved in the following dosage form: tablet.

Patent	Expires	In	Type
9200002	Oct 15, 2034	in 8 yr 5 mo	SubstanceProductU-3168
9944651	Oct 15, 2034	in 8 yr 5 mo	SubstanceProductU-3168
9994575	Oct 15, 2034	in 8 yr 5 mo	SubstanceProductU-3168
11827642	Oct 15, 2034	in 8 yr 5 mo	SubstanceProductU-3506
11999744	Apr 10, 2040	in 14 yr	U-3168
12252494	Apr 10, 2040	in 14 yr	U-3506
11964980	Apr 10, 2040	in 14 yr	SubstanceProduct
12060354	Mar 08, 2042	in 15 yr 11 mo	U-2726

Avapritinib

Brand (NDA) products · tablet

Marketing exclusivity (16)

Listed patents (8)

Avapritinib — frequently asked questions

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