doxycycline hyclate · Mayne Pharma · NDA 050795
Doryx Mpc
Earliest generic entry, as listed
23 Dec 2034
Blocked by patent: US 9446057.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9446057 | drug product, use U-918 · sets the listed date | 23 Dec 2034 |
| US 9295652 | drug product, use U-918 | 23 Oct 2034 |
| US 9511031 | drug product | 23 Oct 2034 |
| US 8715724 | 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050795 · 007 · RLD | tablet, delayed release, oral | EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 23 Dec 2034 |
| 050795 · 008 · RLD · discontinued | tablet, delayed release, oral | EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 23 Dec 2034 |