FDA Orange Book
Generic for Opsumit
Opsumit contains macitentan. 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 Opsumit is macitentan. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Opsumit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | AB | 12 | AB |
NDA 204410, held by ACTELION PHARMACEUTICALS US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic macitentan
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ZYDUS LIFESCIENCES GLOBAL FZE | 211224 | AB (A-rated, therapeutically equivalent) | April 6, 2021 | 10MG |
| AUROBINDO PHARMA LTD | 211198 | AB (A-rated, therapeutically equivalent) | April 18, 2023 | 10MG |
| APOTEX INC | 211195 | AB (A-rated, therapeutically equivalent) | January 9, 2024 | 10MG |
| TORRENT PHARMACEUTICALS LTD | 211107 | AB (A-rated, therapeutically equivalent) | August 5, 2024 | 10MG |
| ALEMBIC PHARMACEUTICALS LTD | 211128 | AB (A-rated, therapeutically equivalent) | August 18, 2025 | 10MG |
| MSN LABORATORIES PRIVATE LTD | 211136 | AB (A-rated, therapeutically equivalent) | August 20, 2025 | 10MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 211123 | AB (A-rated, therapeutically equivalent) | August 26, 2025 | 10MG |
| LAURUS LABS LTD | 211120 | AB (A-rated, therapeutically equivalent) | November 5, 2025 | 10MG |
| LEPU PHARMACEUTICAL TECHNOLOGY CO LTD | 211026 | AB (A-rated, therapeutically equivalent) | December 3, 2025 | 10MG |
| MYLAN PHARMACEUTICALS INC | 211161 | AB (A-rated, therapeutically equivalent) | December 3, 2025 | 10MG |
| AMNEAL EU LTD | 211000 | AB (A-rated, therapeutically equivalent) | June 8, 2026 | 10MG |
| TEVA PHARMACEUTICALS USA INC | 211187 | AB (A-rated, therapeutically equivalent) | June 8, 2026 | 10MG |
Opsumit patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7094781 | December 5, 2025 | Drug substance, Drug product | None | 204410 |
| 7094781*PED | June 5, 2026 | Method of use | None | 204410 |
| 10946015 | September 11, 2026 | Drug product | U-1445 | 204410 |
| 10946015*PED | March 11, 2027 | Method of use | None | 204410 |
| 9265762 | May 29, 2027 | Drug product | U-1820 | 204410 |
| 9265762*PED | November 29, 2027 | Method of use | None | 204410 |
| 8367685 | October 4, 2028 | Drug product | U-1445 | 204410 |
| 8367685*PED | April 4, 2029 | Method of use | None | 204410 |
| 8268847 | April 18, 2029 | Method of use | U-1446 | 204410 |
| 8268847*PED | October 18, 2029 | Method of use | None | 204410 |
Opsumit exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-187 | Miscellaneous | February 28, 2028 | 204410 |
| PED | Pediatric exclusivity | August 28, 2028 | 204410 |
Opsumit NDC codes
Questions
Is there a generic for Opsumit?
Yes. The generic name for Opsumit is macitentan. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Opsumit?
The active ingredient in Opsumit is macitentan, per the FDA Orange Book.
When does the Opsumit patent expire?
The last patent listed for Opsumit in the Orange Book expires October 18, 2029. 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.