minocycline hydrochloride · Rempex · NDA 050315, 050444, 050445, 050649
Minocin
Earliest generic entry, as listed · earliest of 3 marketed strengths
16 Oct 2032
2 of 3 marketed strengths have no unexpired patent or exclusivity listed.
Blocked by patent: US 11944634.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11944634 | product | 16 Oct 2032 |
| US 12161656 | product | 12 May 2031 |
| US 9084802 | use U-282 | 12 May 2031 |
| US 9278105 | use U-282 | 12 May 2031 |
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 |
|---|---|---|---|
| 050315 · 001 · discontinued | capsule, oral | EQ 100MG BASE | open |
| 050315 · 002 · discontinued | capsule, oral | EQ 50MG BASE | open |
| 050444 · 001 · RLD | injectable, injection | EQ 100MG BASE/VIAL | 16 Oct 2032 |
| 050445 · 001 · discontinued | suspension, oral | EQ 50MG BASE/5ML | open |
| 050649 · 001 · RLD | capsule, oral | EQ 50MG BASE | open |
| 050649 · 002 · RLD | capsule, oral | EQ 100MG BASE | open |
| 050649 · 003 · RLD · discontinued | capsule, oral | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |