Orange Book product · Brand (NDA)
ONGENTYS
OPICAPONE
At a glance
Apr 24, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 24, 2020
6 yr 3 mo ago
Today
Patent 9550759 expires
Listed method-of-use patent (U-3870) expiration.
Jul 26, 2026
in 1 mo
Patent 9550759 expires
Listed method-of-use patent (U-3871) expiration.
Jul 26, 2026
in 1 mo
Patent 9550759 expires
Listed method-of-use patent (U-3872) expiration.
Jul 26, 2026
in 1 mo
Patent 8907099 expires
Listed drug substance patent expiration.
May 12, 2027
in 11 mo
Patent 9745290 expires
Listed drug product patent expiration.
Oct 10, 2027
in 1 yr 4 mo
Patent 8168793 expires
Listed drug substance patent expiration.
Apr 02, 2029
in 2 yr 10 mo
Patent 8524746 expires
Listed method-of-use patent (U-3869) expiration.
Jul 14, 2029
in 3 yr 1 mo
Patent 10071085 expires
Listed drug product patent expiration.
Mar 31, 2030
in 3 yr 10 mo
Patent 10583130 expires
Listed method-of-use patent (U-3869) expiration.
Mar 31, 2030
in 3 yr 10 mo
Patent 12129247 expires
Listed method-of-use patent (U-4038) expiration.
Jan 11, 2032
in 5 yr 8 mo
Patent 9630955 expires
Listed drug substance patent expiration.
Dec 12, 2032
in 6 yr 7 mo
Pharmaceutical detail
Active ingredient
OPICAPONE
Strength
25MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 212489
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9550759 | Jul 26, 2026 | in 1 mo | U-3870 |
| 9550759 | Jul 26, 2026 | in 1 mo | U-3871 |
| 9550759 | Jul 26, 2026 | in 1 mo | U-3872 |
| 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 |
| 10071085 | Mar 31, 2030 | in 3 yr 10 mo | Product |
| 10583130 | Mar 31, 2030 | in 3 yr 10 mo | U-3869 |
| 12129247 | Jan 11, 2032 | in 5 yr 8 mo | U-4038 |
| 9630955 | Dec 12, 2032 | in 6 yr 7 mo | SubstanceProductU-3869 |

