benzoyl peroxide; clindamycin phosphate · Bausch · NDA 050819
Onexton
Earliest generic entry, as listed
5 Aug 2029
Blocked by patent: US 8288434.
Listed patents · 5 unexpired
13 Orange Book listing rows for 5 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8288434 | drug product, use U-1033, U-124, U-134, U-818, U-916, U-921 | 5 Aug 2029 |
| US 8288434 listing row | drug product, use U-1033 · sets the listed date | 5 Aug 2029 |
| US 8288434 listing row | drug product, use U-124 · sets the listed date | 5 Aug 2029 |
| US 8288434 listing row | drug product, use U-134 · sets the listed date | 5 Aug 2029 |
| US 8288434 listing row | drug product, use U-818 · sets the listed date | 5 Aug 2029 |
| US 8288434 listing row | drug product, use U-916 · sets the listed date | 5 Aug 2029 |
| US 8288434 listing row | drug product, use U-921 · sets the listed date | 5 Aug 2029 |
| US 10137142 | drug product, use U-916 | 3 Jun 2029 |
| US 10220049 | drug product, use U-916 | 3 Jun 2029 |
| US 9504704 | drug product, use U-124, U-134, U-818, U-916 | 3 Jun 2029 |
| US 9504704 listing row | drug product, use U-124 | 3 Jun 2029 |
| US 9504704 listing row | drug product, use U-134 | 3 Jun 2029 |
| US 9504704 listing row | drug product, use U-818 | 3 Jun 2029 |
| US 9504704 listing row | drug product, use U-916 | 3 Jun 2029 |
| US 9561208 | drug product, use U-916 | 3 Jun 2029 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050819 · 002 · RLD | gel, topical | 3.75%;EQ 1.2% BASE | 5 Aug 2029 |