FDA Orange Book
Generic for Promacta
Promacta 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 is eltrombopag olamine. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Promacta products the Orange Book lists.
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Promacta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 100MG ACID | Discontinued | None | 0 | None |
| tablet, oral | EQ 12.5MG ACID | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | EQ 25MG ACID | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | EQ 50MG ACID | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | EQ 75MG ACID | Marketed (Rx) | AB | 9 | AB |
NDA 022291, 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 |
|---|---|---|---|---|
| HETERO LABS LTD UNIT V | 206788 | AB (A-rated, therapeutically equivalent) | January 17, 2025 | EQ 12.5MG ACID, EQ 25MG ACID, EQ 50MG ACID, EQ 75MG ACID |
| AMNEAL EU LTD | 212884 | AB (A-rated, therapeutically equivalent) | January 14, 2026 | EQ 12.5MG ACID, EQ 25MG ACID, EQ 50MG ACID, EQ 75MG ACID |
| MSN LABORATORIES PRIVATE LTD | 220250 | AB (A-rated, therapeutically equivalent) | January 14, 2026 | EQ 12.5MG ACID, EQ 25MG ACID, EQ 50MG ACID, EQ 75MG ACID |
| SOMERSET THERAPEUTICS LLC | 219638 | AB (A-rated, therapeutically equivalent) | January 14, 2026 | EQ 12.5MG ACID, EQ 25MG ACID, EQ 50MG ACID, EQ 75MG ACID |
| ZYDUS PHARMACEUTICALS USA INC | 216281 | AB (A-rated, therapeutically equivalent) | January 14, 2026 | EQ 12.5MG ACID, EQ 25MG ACID, EQ 50MG ACID, EQ 75MG ACID |
| DR REDDYS LABORATORIES LTD | 219121 | AB (A-rated, therapeutically equivalent) | March 16, 2026 | EQ 12.5MG ACID, EQ 25MG ACID, EQ 50MG ACID, EQ 75MG ACID |
| HIKMA PHARMACEUTICALS USA INC | 220033 | AB (A-rated, therapeutically equivalent) | April 8, 2026 | EQ 12.5MG ACID, EQ 25MG ACID, EQ 50MG ACID, EQ 75MG ACID |
| BIOCON PHARMA LTD | 220660 | AB (A-rated, therapeutically equivalent) | April 28, 2026 | EQ 12.5MG ACID, EQ 25MG ACID, EQ 50MG ACID, EQ 75MG ACID |
| ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 208815 | AB (A-rated, therapeutically equivalent) | June 17, 2026 | EQ 50MG ACID |
| TEVA PHARMACEUTICALS USA INC | 209938 | AB (A-rated, therapeutically equivalent) | July 13, 2026 | EQ 12.5MG ACID, EQ 25MG ACID, EQ 75MG ACID |
Promacta patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7547719 | July 13, 2025 | Drug substance, Drug product | U-2451 | 022291 |
| 7547719 | July 13, 2025 | Drug substance, Drug product | U-1575 | 022291 |
| 7547719 | July 13, 2025 | Drug substance, Drug product | U-2452 | 022291 |
| 7547719 | July 13, 2025 | Drug substance, Drug product | U-1306 | 022291 |
| 7547719 | July 13, 2025 | Drug substance, Drug product | U-930 | 022291 |
| 7547719*PED | January 13, 2026 | Method of use | None | 022291 |
Promacta NDC codes
Questions
Is there a generic for Promacta?
Yes. The generic name for Promacta is eltrombopag olamine. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Promacta products the Orange Book lists.
What is the generic name for Promacta?
The active ingredient in Promacta is eltrombopag olamine, per the FDA Orange Book.
When does the Promacta patent expire?
The last patent listed for Promacta 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.
More on Promacta and Eltrombopag Olamine
- What is Promacta used for?FDA label uses
- Is Promacta a controlled substance?Federal schedule
- Generic for Promacta KitFDA Orange Book
- Thrombopoietin Receptor Agonists listFDA drug class
- Promacta Medicare Part D coverageBy plan and state
- NDC 0078-0684Promacta NDC record
- NDC 0078-0685Promacta NDC record
- NDC 0078-0686Promacta NDC record