opicapone · Amneal · NDA 212489
Ongentys
Earliest generic entry, as listed · earliest of 2 marketed strengths
12 Dec 2032
Blocked by patent: US 9630955.
Listed patents · 8 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9630955 | substance, product, use U-3869 | 12 Dec 2032 |
| US 8168793 | substance, product, use U-3869 | 7 Apr 2032 |
| US 12129247 | use U-4038 | 11 Jan 2032 |
| US 10071085 | product | 31 Mar 2030 |
| US 10583130 | use U-3869 | 31 Mar 2030 |
| US 8524746 | use U-3869 | 14 Jul 2029 |
| US 9745290 | product, use U-3869 | 10 Oct 2027 |
| US 8907099 | substance | 12 May 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 212489 · 001 · RLD | capsule, oral | 25MG | 12 Dec 2032 |
| 212489 · 002 · RLD | capsule, oral | 50MG | 12 Dec 2032 |
Expired or delisted (3)
- US 9550759 · use U-3872 · 26 Jul 2026
- US 9550759 · use U-3871 · 26 Jul 2026
- US 9550759 · use U-3870 · 26 Jul 2026