Orange Book product · Brand (NDA)
DOPTELET
AVATROMBOPAG MALEATE
At a glance
May 21, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 21, 2018
8 yr 2 mo ago
Today
Exclusivity ends · ODE-246
Orphan-drug exclusivity (7 years)
Jun 26, 2026
in 7 d
Patent 7638536 expires
Listed drug substance patent expiration.
Jul 28, 2027
in 1 yr 1 mo
Exclusivity ends · I-974
New indication 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 20MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 210238
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 (3)
- ODE-246Orphan-drug exclusivity (7 years)
Jun 26, 2026
in 7 d
- I-974New indication 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 |
