Is there a generic for Avapritinib?

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

What is the reference-listed drug for Avapritinib?

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

What patents protect Avapritinib?

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.

Does Avapritinib have FDA marketing exclusivity?

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.

What dosage forms of Avapritinib are approved?

Avapritinib is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Avapritinib

Avapritinib: 1 brand, 0 generics; first approved Jan 09, 2020; on patent until Oct 15, 2034.

On patent16 exclusivity periods

Generic status & protection

Protected until Oct 15, 2034 (earliest listed patent expiry).

Earliest patent expiry Oct 15, 2034Latest exclusivity ends May 22, 2030

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 15, 2034

in 8 yr 4 mo

Originator applications

Brand (NDA) products

AYVAKITRLD

BLUEPRINT MEDICINESNDA 21260820215 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Rx	—
200MG	TABLET	ORAL	Rx	—
300MG	TABLET	ORAL	Rx	—
25MG	TABLET	ORAL	Rx	—
50MG	TABLET	ORAL	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (16)

I-912New indication exclusivity (3 years)
May 22, 2026
2 mo ago
ODE-356Orphan-drug exclusivity (7 years)
Jun 16, 2028
in 1 yr 11 mo
ODE-366Orphan-drug exclusivity (7 years)
Jan 09, 2027
in 6 mo
ODE-434Orphan-drug exclusivity (7 years)
May 22, 2030
in 3 yr 11 mo
ODE-356Orphan-drug exclusivity (7 years)
Jun 16, 2028
in 1 yr 11 mo
ODE-366Orphan-drug exclusivity (7 years)
Jan 09, 2027
in 6 mo
ODE-434Orphan-drug exclusivity (7 years)
May 22, 2030
in 3 yr 11 mo
ODE-356Orphan-drug exclusivity (7 years)
Jun 16, 2028
in 1 yr 11 mo
ODE-366Orphan-drug exclusivity (7 years)
Jan 09, 2027
in 6 mo
ODE-434Orphan-drug exclusivity (7 years)
May 22, 2030
in 3 yr 11 mo
ODE-356Orphan-drug exclusivity (7 years)
Jun 16, 2028
in 1 yr 11 mo
ODE-366Orphan-drug exclusivity (7 years)
Jan 09, 2027
in 6 mo
ODE-434Orphan-drug exclusivity (7 years)
May 22, 2030
in 3 yr 11 mo
ODE-356Orphan-drug exclusivity (7 years)
Jun 16, 2028
in 1 yr 11 mo
ODE-366Orphan-drug exclusivity (7 years)
Jan 09, 2027
in 6 mo
ODE-434Orphan-drug exclusivity (7 years)
May 22, 2030
in 3 yr 11 mo

Orange Book patent file

Listed patents

Listed patents (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9200002	Oct 15, 2034	in 8 yr 4 mo	SubstanceProductU-3168
9944651	Oct 15, 2034	in 8 yr 4 mo	SubstanceProductU-3168
9994575	Oct 15, 2034	in 8 yr 4 mo	SubstanceProductU-3168
11827642	Oct 15, 2034	in 8 yr 4 mo	SubstanceProductU-3506
11999744	Apr 10, 2040	in 13 yr 11 mo	U-3168
12252494	Apr 10, 2040	in 13 yr 11 mo	U-3506
11964980	Apr 10, 2040	in 13 yr 11 mo	SubstanceProduct
12060354	Mar 08, 2042	in 15 yr 10 mo	U-2726

FDA approval span

Approval history

First approval

Jan 09, 2020

6 yr 7 mo ago

Most recent approval

Jun 16, 2021

5 yr 2 mo ago

Approvals span 2020–2021 across 1 FDA application.

Brand (NDA) 1100%

Generic (ANDA) 00%

Avapritinib — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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