benzoyl peroxide; tretinoin · Mayne Pharma · NDA 214902
Twyneo
Earliest generic entry, as listed
23 May 2041
Blocked by patent: US 12133919, US 12257348, US 12491163.
Listed patents · 13 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12133919 | drug product, use U-3987 · sets the listed date | 23 May 2041 |
| US 12257348 | drug product, use U-3987 · sets the listed date | 23 May 2041 |
| US 12491163 | drug product, use U-3987 · sets the listed date | 23 May 2041 |
| US 12295935 | use U-3987 | 27 Dec 2040 |
| US 10420743 | use U-3194 | 12 Jul 2038 |
| US 12357602 | drug product, use U-3987 | 12 Jul 2038 |
| US 12053546 | drug product | 29 Jun 2032 |
| US 10653899 | drug product, use U-3194 | 30 Dec 2030 |
| US 11071878 | drug product | 30 Dec 2030 |
| US 12070629 | drug product, use U-3987 | 30 Dec 2030 |
| US 9868103 | drug product, use U-3194 | 8 Aug 2028 |
| US 12156946 | drug product | 3 Feb 2028 |
| US 8617580 | drug product | 3 Feb 2028 |
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 |
|---|---|---|---|
| 214902 · 001 · RLD | cream, topical | 3%;0.1% | 23 May 2041 |