Is Ayvakit still available?

Yes. Ayvakit (NDA 212608) is listed with marketing status Prescription in the FDA Orange Book.

Does Ayvakit have a generic?

The FDA Orange Book does not currently list an approved generic (ANDA) sharing Ayvakit's active ingredient (Avapritinib).

When do Ayvakit's patents expire?

The FDA Orange Book lists 5 patents against Ayvakit, with the last listed patent expiring Apr 10, 2040. A generic launching before a listed patent expires generally must file a Paragraph IV certification.

Does Ayvakit have FDA marketing exclusivity?

Yes. The Orange Book records 3 marketing-exclusivity periods for Ayvakit. Exclusivity can delay generic approval independently of any listed patents.

What is Ayvakit's FDA application number?

Ayvakit is approved under NDA 212608, held by Blueprint Medicines.

Orange Book product · Brand (NDA)

Ayvakit

Avapritinib

Brand (NDA)NDA 212608RLD Blueprint Medicines

Approved

Jun 16, 2021

Application

Brand (NDA)

TE code

Not listed

Listed patents

Ayvakit (Avapritinib) is Blueprint Medicines's brand-name drug, approved by the FDA under NDA 212608 in 2021. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. The FDA Orange Book lists 5 patents against it, the last expiring 2040. 3 marketing-exclusivity periods are recorded.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Jun 16, 2021
5 yr 2 mo ago
Today
Exclusivity ends · ODE-366
Orphan-drug exclusivity (7 years)
Jan 09, 2027
in 6 mo
Exclusivity ends · ODE-356
Orphan-drug exclusivity (7 years)
Jun 16, 2028
in 2 yr
Exclusivity ends · ODE-434
Orphan-drug exclusivity (7 years)
May 22, 2030
in 3 yr 11 mo
Patent 9200002 expires
Listed drug substance patent expiration.
Oct 15, 2034
in 8 yr 5 mo
Patent 9944651 expires
Listed drug substance patent expiration.
Oct 15, 2034
in 8 yr 5 mo
Patent 9994575 expires
Listed drug substance patent expiration.
Oct 15, 2034
in 8 yr 5 mo
Patent 11964980 expires
Listed drug substance patent expiration.
Apr 10, 2040
in 13 yr 11 mo
Patent 11999744 expires
Listed method-of-use patent (U-3168) expiration.
Apr 10, 2040
in 13 yr 11 mo

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

AVAPRITINIB

Strength

50MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 212608

Product number

005

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Same application

Other strengths in NDA 212608

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

No other applications share this active ingredient.

View full Avapritinib family

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (3)

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

Orange Book patent file

Listed patents

Listed patents (5)

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 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
11964980	Apr 10, 2040	in 13 yr 11 mo	SubstanceProduct
11999744	Apr 10, 2040	in 13 yr 11 mo	U-3168

Ayvakit — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Avapritinib active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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