FDA Orange Book
Is there a generic for Opsynvi?
Opsynvi contains macitentan and tadalafil. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Opsynvi (macitentan and tadalafil). The Orange Book shows its last listed patent expires October 18, 2029 and its last listed exclusivity ends September 22, 2031.
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Opsynvi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG;20MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 10MG;40MG | Marketed (Rx) | None | 0 | None |
NDA 218490, 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.
Opsynvi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7094781 | December 5, 2025 | Drug substance, Drug product | None | 218490 |
| 7094781*PED | June 5, 2026 | Method of use | None | 218490 |
| 10946015 | September 11, 2026 | Drug product | U-3881 | 218490 |
| 10946015*PED | March 11, 2027 | Method of use | None | 218490 |
| 8268847 | April 18, 2029 | Drug product | U-3882 | 218490 |
| 8268847*PED | October 18, 2029 | Method of use | None | 218490 |
Opsynvi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | March 22, 2027 | 218490 |
| PED | Pediatric exclusivity | September 22, 2027 | 218490 |
| ODE-475 | Orphan drug exclusivity | March 22, 2031 | 218490 |
| PED | Pediatric exclusivity | September 22, 2031 | 218490 |
Opsynvi NDC codes
Questions
Is there a generic for Opsynvi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Opsynvi (macitentan and tadalafil). The Orange Book shows its last listed patent expires October 18, 2029 and its last listed exclusivity ends September 22, 2031.
What is the generic name for Opsynvi?
The active ingredient in Opsynvi is macitentan and tadalafil, per the FDA Orange Book.
When does the Opsynvi patent expire?
The last patent listed for Opsynvi 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.