delafloxacin meglumine · Melinta · NDA 208610, 208611
Baxdela
Earliest generic entry, as listed · earliest of 2 marketed strengths
19 Jun 2031
Other strengths are listed to 2 Jun 2034.
Blocked by patent: US 7728143.
Listed patents · 11 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12036219 | use U-3967 | 2 Jun 2034 |
| US 12558349 | use U-3967 | 14 Mar 2034 |
| US 9493582 | drug product | 27 Feb 2033 |
| US 12138257 | drug product | 1 May 2032 |
| US 7728143 | drug substance · sets the listed date | 19 Jun 2031 |
| US RE46617 | drug substance | 28 Dec 2029 |
| US 8871938 | drug substance | 23 Sep 2029 |
| US 7635773 | drug product | 13 Mar 2029 |
| US 8410077 | drug product | 13 Mar 2029 |
| US 9200088 | drug product | 13 Mar 2029 |
| US 9750822 | drug product | 13 Mar 2029 |
Exclusivities · 1 unexpired
| GAIN | qualified infectious disease product | 19 Jun 2027 |
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 |
|---|---|---|---|
| 208610 · 001 · RLD | tablet, oral | EQ 450MG BASE | 19 Jun 2031 |
| 208611 · 001 · RLD | powder, intravenous | EQ 300MG BASE/VIAL | 2 Jun 2034 |
Expired or delisted (3)
- US 8252813 · product, use U-2028 · 2 Oct 2026
- US 8273892 · substance · 6 Aug 2026
- NCE · 19 Jun 2022