doxycycline hyclate · Mayne Pharma · NDA 050582, 050795
Doryx
Earliest generic entry, as listed · earliest of 8 marketed strengths
3 Feb 2028
2 of 8 marketed strengths have no unexpired patent or exclusivity listed; no marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8715724.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8715724 | 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 · 8
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050582 · 001 · RLD · discontinued | capsule, delayed release, oral | EQ 100MG BASE | open |
| 050582 · 002 · RLD · discontinued | capsule, delayed release, oral | EQ 75MG BASE | open |
| 050795 · 001 · RLD · discontinued | tablet, delayed release, oral | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 3 Feb 2028 |
| 050795 · 002 · RLD · discontinued | tablet, delayed release, oral | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 3 Feb 2028 |
| 050795 · 003 · RLD · discontinued | tablet, delayed release, oral | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 3 Feb 2028 |
| 050795 · 004 · RLD · discontinued | tablet, delayed release, oral | EQ 80MG BASE | 3 Feb 2028 |
| 050795 · 005 · RLD · discontinued | tablet, delayed release, oral | EQ 200MG BASE | 3 Feb 2028 |
| 050795 · 006 · RLD · discontinued | tablet, delayed release, oral | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 3 Feb 2028 |