buprenorphine · Braeburn · NDA 210136
Brixadi
Earliest generic entry, as listed · earliest of 7 marketed strengths
26 Jul 2032
Blocked by patent: US 10912772, US 11110084, US 11135215, US 12161640, US 12318379, US 9937164.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10912772 | use U-3617 | 26 Jul 2032 |
| US 11110084 | product, use U-3616 | 26 Jul 2032 |
| US 11135215 | product | 26 Jul 2032 |
| US 12161640 | product, use U-4100 | 26 Jul 2032 |
| US 12318379 | product, use U-4100 | 26 Jul 2032 |
| US 9937164 | product, use U-3618 | 26 Jul 2032 |
| US 8236292 | product, use U-3619 | 10 Jan 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 · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 210136 · 001 · RLD | solution, extended release, subcutaneous | 8MG/0.16ML (50MG/ML) | 26 Jul 2032 |
| 210136 · 002 · RLD | solution, extended release, subcutaneous | 16MG/0.32ML (50MG/ML) | 26 Jul 2032 |
| 210136 · 003 · RLD | solution, extended release, subcutaneous | 24MG/0.48ML (50MG/ML) | 26 Jul 2032 |
| 210136 · 004 · RLD | solution, extended release, subcutaneous | 32MG/0.64ML (50MG/ML) | 26 Jul 2032 |
| 210136 · 005 · RLD | solution, extended release, subcutaneous | 64MG/0.18ML (356MG/ML) | 26 Jul 2032 |
| 210136 · 006 · RLD | solution, extended release, subcutaneous | 96MG/0.27ML (356MG/ML) | 26 Jul 2032 |
| 210136 · 007 · RLD | solution, extended release, subcutaneous | 128MG/0.36ML (356MG/ML) | 26 Jul 2032 |
Expired or delisted (2)
- US 8236755 · product, use U-3620 · 31 Jul 2026
- NP · 23 May 2026