FDA Orange Book · active-ingredient family
Eltrombopag olamine
Eltrombopag olamine is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PROMACTA KIT · NDA 207027
2
Brand (NDA)
9
Generics (ANDA)
12
Listed patents
0
Exclusivity periods
Brand (NDA) products · for suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROMACTA KITRLD×2 | NOVARTIS | NDA 207027 | AB | Sep 27, 2018 | |
| PROMACTARLD×5 | NOVARTIS | NDA 022291 | AB | Oct 20, 2011 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ELTROMBOPAG OLAMINE×4 | BIOCON PHARMA | ANDA 220660 | AB | Apr 28, 2026 | |
| ELTROMBOPAG OLAMINE×4 | HIKMA | ANDA 220033 | AB | Apr 08, 2026 | |
| ELTROMBOPAG OLAMINE×4 | DR REDDYS | ANDA 219121 | AB | Mar 16, 2026 | |
| ELTROMBOPAG OLAMINE×4 | AMNEAL | ANDA 212884 | AB | Jan 14, 2026 | |
| ELTROMBOPAG OLAMINE×4 | MSN | ANDA 220250 | AB | Jan 14, 2026 | |
| ELTROMBOPAG OLAMINE×4 | SOMERSET THERAPS LLC | ANDA 219638 | AB | Jan 14, 2026 | |
| ELTROMBOPAG OLAMINE×4 | ZYDUS PHARMS | ANDA 216281 | AB | Jan 14, 2026 | |
| ELTROMBOPAG OLAMINE×4 | HETERO LABS LTD V | ANDA 206788 | AB | Jan 17, 2025 | |
| ELTROMBOPAG OLAMINE×2 | ANNORA PHARMA | ANDA 216620 | AB | Apr 18, 2024 |
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7547719 | Jul 13, 2025 | 11 mo ago | SubstanceProductU-2452 |
| 7547719*PED | Jan 13, 2026 | 5 mo ago | |
| 8052994 | Aug 01, 2027 | in 1 yr 2 mo | ProductU-1714 |
| 8071129 | Aug 01, 2027 | in 1 yr 2 mo | ProductU-2451 |
| 8828430 | Aug 01, 2027 | in 1 yr 2 mo | ProductU-1306 |
| 8062665 | Aug 01, 2027 | in 1 yr 2 mo | ProductU-1714 |
| 8052993 | Aug 01, 2027 | in 1 yr 2 mo | ProductU-1714 |
| 8828430*PED | Feb 01, 2028 | in 1 yr 8 mo | |
| 8071129*PED | Feb 01, 2028 | in 1 yr 8 mo | |
| 8062665*PED | Feb 01, 2028 | in 1 yr 8 mo | |
| 8052993*PED | Feb 01, 2028 | in 1 yr 8 mo | |
| 8052994*PED | Feb 01, 2028 | in 1 yr 8 mo |
Eltrombopag olamine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
