FDA Orange Book
Is there a generic for Ongentys?
Ongentys contains opicapone. 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 Ongentys (opicapone). The Orange Book shows its last listed patent expires December 12, 2032.
Run it in Rivvi
Map Ongentys and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Ongentys products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 25MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 50MG | Marketed (Rx) | None | 0 | None |
NDA 212489, held by AMNEAL PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ongentys patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9550759 | July 26, 2026 | Method of use | U-3870 | 212489 |
| 9550759 | July 26, 2026 | Method of use | U-3871 | 212489 |
| 9550759 | July 26, 2026 | Method of use | U-3872 | 212489 |
| 8907099 | May 12, 2027 | Drug substance | None | 212489 |
| 9745290 | October 10, 2027 | Drug product | U-3869 | 212489 |
| 8524746 | July 14, 2029 | Method of use | U-3869 | 212489 |
| 10583130 | March 31, 2030 | Method of use | U-3869 | 212489 |
| 10071085 | March 31, 2030 | Drug product | None | 212489 |
| 12129247 | January 11, 2032 | Method of use | U-4038 | 212489 |
| 8168793 | April 7, 2032 | Drug substance, Drug product | U-3869 | 212489 |
| 9630955 | December 12, 2032 | Drug substance, Drug product | U-3869 | 212489 |
Ongentys NDC codes
Questions
Is there a generic for Ongentys?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ongentys (opicapone). The Orange Book shows its last listed patent expires December 12, 2032.
What is the generic name for Ongentys?
The active ingredient in Ongentys is opicapone, per the FDA Orange Book.
When does the Ongentys patent expire?
The last patent listed for Ongentys in the Orange Book expires December 12, 2032. 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.