buprenorphine hydrochloride; naloxone hydrochloride · Bdsi · NDA 205637
Bunavail
Earliest generic entry, as listed · earliest of 3 marketed strengths
24 Apr 2035
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 9522188.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9522188 | drug product · sets the listed date | 24 Apr 2035 |
| US 8703177 | drug product | 20 Aug 2032 |
| US 8147866 | drug product, use U-1521 | 23 Jul 2027 |
| US 9655843 | drug product, use U-2017 | 23 Jul 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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205637 · 001 · RLD · discontinued | film, buccal | EQ 2.1MG BASE;EQ 0.3MG BASE | 24 Apr 2035 |
| 205637 · 002 · RLD · discontinued | film, buccal | EQ 4.2MG BASE;EQ 0.7MG BASE | 24 Apr 2035 |
| 205637 · 003 · RLD · discontinued | film, buccal | EQ 6.3MG BASE;EQ 1MG BASE | 24 Apr 2035 |