buprenorphine hydrochloride · Bdsi · NDA 207932
Belbuca
Earliest generic entry, as listed · earliest of 7 marketed strengths
21 Dec 2032
Blocked by patent: US 9901539. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9901539 | use U-1556 | 21 Dec 2032 |
| US 8147866 | product, use U-1769 | 23 Jul 2027 |
| US 9655843 | product, use U-1556 | 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 · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 207932 · 001 · RLD | film, buccal | EQ 0.075MG BASE | 21 Dec 2032 |
| 207932 · 002 · RLD | film, buccal | EQ 0.15MG BASE | 21 Dec 2032 |
| 207932 · 003 · RLD | film, buccal | EQ 0.3MG BASE | 21 Dec 2032 |
| 207932 · 004 · RLD | film, buccal | EQ 0.45MG BASE | 21 Dec 2032 |
| 207932 · 005 · RLD | film, buccal | EQ 0.6MG BASE | 21 Dec 2032 |
| 207932 · 006 · RLD | film, buccal | EQ 0.75MG BASE | 21 Dec 2032 |
| 207932 · 007 · RLD | film, buccal | EQ 0.9MG BASE | 21 Dec 2032 |