Orange Book product · Brand (NDA)
PROMACTA
ELTROMBOPAG OLAMINE
At a glance
Oct 20, 2011
Approved
Brand (NDA)
Application
AB
TE code
18
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 20, 2011
14 yr 11 mo ago
Patent 7547719 expires
Listed drug substance patent expiration.
Jul 13, 2025
11 mo ago
Patent 7547719 expires
Listed drug substance patent expiration.
Jul 13, 2025
11 mo ago
Patent 7547719 expires
Listed drug substance patent expiration.
Jul 13, 2025
11 mo ago
Patent 7547719 expires
Listed drug substance patent expiration.
Jul 13, 2025
11 mo ago
Patent 7547719*PED expires
Listed listed patent expiration.
Jan 13, 2026
5 mo ago
Today
Patent 8052993 expires
Listed drug product patent expiration.
Aug 01, 2027
in 1 yr 2 mo
Patent 8052994 expires
Listed drug product patent expiration.
Aug 01, 2027
in 1 yr 2 mo
Patent 8062665 expires
Listed drug product patent expiration.
Aug 01, 2027
in 1 yr 2 mo
Patent 8071129 expires
Listed drug product patent expiration.
Aug 01, 2027
in 1 yr 2 mo
Patent 8071129 expires
Listed drug product patent expiration.
Aug 01, 2027
in 1 yr 2 mo
Patent 8071129 expires
Listed drug product patent expiration.
Aug 01, 2027
in 1 yr 2 mo
Patent 8828430 expires
Listed drug product patent expiration.
Aug 01, 2027
in 1 yr 2 mo
Patent 8828430 expires
Listed drug product patent expiration.
Aug 01, 2027
in 1 yr 2 mo
Patent 8052993*PED expires
Listed listed patent expiration.
Feb 01, 2028
in 1 yr 8 mo
Patent 8052994*PED expires
Listed listed patent expiration.
Feb 01, 2028
in 1 yr 8 mo
Patent 8062665*PED expires
Listed listed patent expiration.
Feb 01, 2028
in 1 yr 8 mo
Patent 8071129*PED expires
Listed listed patent expiration.
Feb 01, 2028
in 1 yr 8 mo
Patent 8828430*PED expires
Listed listed patent expiration.
Feb 01, 2028
in 1 yr 8 mo
Pharmaceutical detail
Active ingredient
ELTROMBOPAG OLAMINE
Strength
EQ 12.5MG ACID
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 022291
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.
- 2018PROMACTA KITBrand (NDA)
NDA 207027 · NOVARTIS
- 2026ELTROMBOPAG OLAMINEGeneric (ANDA)
ANDA 220660 · BIOCON PHARMA
- 2026ELTROMBOPAG OLAMINEGeneric (ANDA)
ANDA 220033 · HIKMA
- 2026ELTROMBOPAG OLAMINEGeneric (ANDA)
ANDA 219121 · DR REDDYS
- 2026ELTROMBOPAG OLAMINEGeneric (ANDA)
ANDA 212884 · AMNEAL
- 2026ELTROMBOPAG OLAMINEGeneric (ANDA)
ANDA 220250 · MSN
- 2026ELTROMBOPAG OLAMINEGeneric (ANDA)
ANDA 219638 · SOMERSET THERAPS LLC
- 2026ELTROMBOPAG OLAMINEGeneric (ANDA)
ANDA 216281 · ZYDUS PHARMS
- 2025ELTROMBOPAG OLAMINEGeneric (ANDA)
ANDA 206788 · HETERO LABS LTD V
- 2024ELTROMBOPAG OLAMINEGeneric (ANDA)
ANDA 216620 · ANNORA PHARMA
Listed patents (18)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7547719 | Jul 13, 2025 | 11 mo ago | SubstanceProductU-2451 |
| 7547719 | Jul 13, 2025 | 11 mo ago | SubstanceProductU-1575 |
| 7547719 | Jul 13, 2025 | 11 mo ago | SubstanceProductU-2452 |
| 7547719 | Jul 13, 2025 | 11 mo ago | SubstanceProductU-1306 |
| 7547719*PED | Jan 13, 2026 | 5 mo ago | |
| 8052993 | Aug 01, 2027 | in 1 yr 2 mo | ProductU-1714 |
| 8052994 | Aug 01, 2027 | in 1 yr 2 mo | ProductU-1714 |
| 8062665 | Aug 01, 2027 | in 1 yr 2 mo | ProductU-1714 |
| 8071129 | Aug 01, 2027 | in 1 yr 2 mo | ProductU-2451 |
| 8071129 | Aug 01, 2027 | in 1 yr 2 mo | ProductU-930 |
| 8071129 | Aug 01, 2027 | in 1 yr 2 mo | ProductU-1306 |
| 8828430 | Aug 01, 2027 | in 1 yr 2 mo | ProductU-1306 |
| 8828430 | Aug 01, 2027 | in 1 yr 2 mo | ProductU-2451 |
| 8052993*PED | Feb 01, 2028 | in 1 yr 8 mo | |
| 8052994*PED | Feb 01, 2028 | in 1 yr 8 mo | |
| 8062665*PED | Feb 01, 2028 | in 1 yr 8 mo | |
| 8071129*PED | Feb 01, 2028 | in 1 yr 8 mo | |
| 8828430*PED | Feb 01, 2028 | in 1 yr 8 mo |
