FDA Orange Book
Generic for Promacta Kit
Promacta Kit contains eltrombopag olamine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Promacta Kit is eltrombopag olamine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Promacta Kit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, oral | EQ 12.5MG ACID/PACKET | Marketed (Rx) | AB | 1 | AB |
| for suspension, oral | EQ 25MG ACID/PACKET | Marketed (Rx) | AB | 1 | AB |
NDA 207027, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic eltrombopag olamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ANNORA PHARMA PRIVATE LTD | 216620 | AB (A-rated, therapeutically equivalent) | April 18, 2024 | EQ 12.5MG ACID/PACKET, EQ 25MG ACID/PACKET |
Promacta Kit patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7547719 | July 13, 2025 | Drug substance, Drug product | U-2452 | 207027 |
| 7547719 | July 13, 2025 | Drug substance, Drug product | U-1736 | 207027 |
| 7547719 | July 13, 2025 | Drug substance, Drug product | U-1575 | 207027 |
| 7547719 | July 13, 2025 | Drug substance, Drug product | U-1306 | 207027 |
| 7547719*PED | January 13, 2026 | Method of use | None | 207027 |
Promacta Kit NDC codes
Questions
Is there a generic for Promacta Kit?
Yes. The generic name for Promacta Kit is eltrombopag olamine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Promacta Kit?
The active ingredient in Promacta Kit is eltrombopag olamine, per the FDA Orange Book.
When does the Promacta Kit patent expire?
The last patent listed for Promacta Kit in the Orange Book expires January 13, 2026. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.