Orange Book product · Brand (NDA)
DOPTELET SPRINKLE
AVATROMBOPAG MALEATE
At a glance
Jul 24, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 24, 2025
11 mo ago
Today
Patent 7638536 expires
Listed drug substance patent expiration.
Jul 28, 2027
in 1 yr 1 mo
Exclusivity ends · NP
New product exclusivity (3 years)
Jul 24, 2028
in 2 yr 2 mo
Exclusivity ends · ODE-548
Orphan-drug exclusivity (7 years)
Jul 24, 2032
in 6 yr 2 mo
Pharmaceutical detail
Active ingredient
AVATROMBOPAG MALEATE
Strength
EQ 10MG BASE
Dosage form
GRANULE
Route
ORAL
TE code
Not listed
Application
NDA 219696
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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 (2)
- NPNew product exclusivity (3 years)
Jul 24, 2028
in 2 yr 2 mo
- ODE-548Orphan-drug exclusivity (7 years)
Jul 24, 2032
in 6 yr 2 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7638536 | Jul 28, 2027 | in 1 yr 1 mo | SubstanceProduct |
