Orange Book product · Brand (NDA)
AYVAKIT
AVAPRITINIB
At a glance
Jun 16, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 16, 2021
5 yr 1 mo ago
Exclusivity ends · I-912
New indication exclusivity (3 years)
May 22, 2026
28 d ago
Today
Exclusivity ends · ODE-366
Orphan-drug exclusivity (7 years)
Jan 09, 2027
in 7 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 4 yr
Patent 11827642 expires
Listed drug substance patent expiration.
Oct 15, 2034
in 8 yr 5 mo
Patent 9200002 expires
Listed drug substance patent expiration.
Oct 15, 2034
in 8 yr 5 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 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 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 14 yr
Patent 11999744 expires
Listed method-of-use patent (U-3168) expiration.
Apr 10, 2040
in 14 yr
Patent 11999744 expires
Listed method-of-use patent (U-3506) expiration.
Apr 10, 2040
in 14 yr
Patent 12252494 expires
Listed method-of-use patent (U-3506) expiration.
Apr 10, 2040
in 14 yr
Pharmaceutical detail
Active ingredient
AVAPRITINIB
Strength
25MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 212608
Product number
004
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (4)
- I-912New indication exclusivity (3 years)
May 22, 2026
28 d ago
- ODE-366Orphan-drug exclusivity (7 years)
Jan 09, 2027
in 7 mo
- ODE-356Orphan-drug exclusivity (7 years)
Jun 16, 2028
in 2 yr
- ODE-434Orphan-drug exclusivity (7 years)
May 22, 2030
in 4 yr
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11827642 | Oct 15, 2034 | in 8 yr 5 mo | SubstanceProductU-3506 |
| 9200002 | Oct 15, 2034 | in 8 yr 5 mo | SubstanceProductU-3168 |
| 9200002 | Oct 15, 2034 | in 8 yr 5 mo | SubstanceProductU-3506 |
| 9944651 | Oct 15, 2034 | in 8 yr 5 mo | SubstanceProductU-3168 |
| 9944651 | Oct 15, 2034 | in 8 yr 5 mo | SubstanceProductU-3506 |
| 9994575 | Oct 15, 2034 | in 8 yr 5 mo | SubstanceProductU-3168 |
| 9994575 | Oct 15, 2034 | in 8 yr 5 mo | SubstanceProductU-3506 |
| 11964980 | Apr 10, 2040 | in 14 yr | SubstanceProduct |
| 11999744 | Apr 10, 2040 | in 14 yr | U-3168 |
| 11999744 | Apr 10, 2040 | in 14 yr | U-3506 |
| 12252494 | Apr 10, 2040 | in 14 yr | U-3506 |
