minocycline hydrochloride · Bausch · NDA 050808
Solodyn
Earliest generic entry, as listed · earliest of 8 marketed strengths
7 Mar 2027
Other strengths are listed to 17 Nov 2031; no marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 7919483. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9192615 | drug product | 17 Nov 2031 |
| US 7541347 | use U-917 | 2 Apr 2027 |
| US 7544373 | drug product | 2 Apr 2027 |
| US 7919483 | use U-1078 · sets the listed date | 7 Mar 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
- Enters 12-month window basis: patent, carve-out possible · 050808-003Listed date 7 Mar 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent, carve-out possible · 050808-006Listed date 7 Mar 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent · 050808-002Listed date 2 Apr 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent, carve-out possible · 050808-007Listed date 7 Mar 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent, carve-out possible · 050808-008Listed date 7 Mar 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent, carve-out possible · 050808-001Listed date 7 Mar 2027Detected 24 Oct 2026
Products covered · 8
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050808 · 001 · RLD · discontinued | tablet, extended release, oral | EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 7 Mar 2027 |
| 050808 · 002 · RLD · discontinued | tablet, extended release, oral | EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2 Apr 2027 |
| 050808 · 003 · RLD · discontinued | tablet, extended release, oral | EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 7 Mar 2027 |
| 050808 · 004 · RLD · discontinued | tablet, extended release, oral | EQ 65MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 17 Nov 2031 |
| 050808 · 005 · RLD · discontinued | tablet, extended release, oral | EQ 115MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 17 Nov 2031 |
| 050808 · 006 · RLD · discontinued | tablet, extended release, oral | EQ 105MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 7 Mar 2027 |
| 050808 · 007 · RLD · discontinued | tablet, extended release, oral | EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 7 Mar 2027 |
| 050808 · 008 · RLD · discontinued | tablet, extended release, oral | EQ 55MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 7 Mar 2027 |