omadacycline tosylate · Paratek Pharms · NDA 209816, 209817
Nuzyra
Earliest generic entry, as listed · earliest of 2 marketed strengths
31 Oct 2037
Blocked by patent: US 10383884, US 10835542. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 9 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10383884 | use U-2576 | 31 Oct 2037 |
| US 10835542 | use U-2576 | 31 Oct 2037 |
| US 10111890 | use U-2444 | 3 Aug 2037 |
| US 9314475 | product | 18 Mar 2031 |
| US 9265740 | product, use U-1569 | 24 Oct 2030 |
| US 8383610 | substance | 23 Sep 2030 |
| US 10124014 | use U-2449 | 5 Mar 2029 |
| US 9265740 | product | 5 Mar 2029 |
| US 9724358 | use U-1569 | 5 Mar 2029 |
Exclusivities · 2 unexpired
| M-320 | miscellaneous (3 years) | 13 May 2029 |
| GAIN | qualified infectious disease product | 2 Oct 2028 |
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 |
|---|---|---|---|
| 209816 · 001 · RLD | tablet, oral | EQ 150MG BASE | 31 Oct 2037 |
| 209817 · 001 · RLD | powder, intravenous | EQ 100MG BASE/VIAL | 31 Oct 2037 |
Expired or delisted (1)
- NCE · 2 Oct 2023