FDA Orange Book · active-ingredient family
Opicapone
Opicapone is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ONGENTYS · NDA 212489
1
Brand (NDA)
0
Generics (ANDA)
9
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ONGENTYSRLD×2 | AMNEAL | NDA 212489 | — | Apr 24, 2020 |
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9550759 | Jul 26, 2026 | in 1 mo | U-3870 |
| 8907099 | May 12, 2027 | in 11 mo | Substance |
| 9745290 | Oct 10, 2027 | in 1 yr 4 mo | ProductU-3869 |
| 8168793 | Apr 02, 2029 | in 2 yr 10 mo | SubstanceProductU-3869 |
| 8524746 | Jul 14, 2029 | in 3 yr 1 mo | U-3869 |
| 10583130 | Mar 31, 2030 | in 3 yr 10 mo | U-3869 |
| 10071085 | Mar 31, 2030 | in 3 yr 10 mo | Product |
| 12129247 | Jan 11, 2032 | in 5 yr 8 mo | U-4038 |
| 9630955 | Dec 12, 2032 | in 6 yr 7 mo | SubstanceProductU-3869 |
Opicapone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
