daptomycin · Sagent Pharms Inc · NDA 208385, 209949, 210282, 217415, 217630
Daptomycin
Earliest generic entry, as listed · earliest of 7 marketed strengths
11 Sep 2033
Other strengths are listed to 9 Jan 2043; 3 of 7 marketed strengths have no unexpired patent or exclusivity listed.
Blocked by patent: US 10357535, US 9655946.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12629337 | drug product | 9 Jan 2043 |
| US 11759497 | drug product | 28 Aug 2038 |
| US 12053502 | use U-3981 | 28 Aug 2038 |
| US 10357535 | drug product, use U-3176 · sets the listed date | 11 Sep 2033 |
| US 9655946 | drug product, use U-3175 · sets the listed date | 11 Sep 2033 |
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 |
|---|---|---|---|
| 208385 · 001 · RLD | powder, intravenous | 350MG/VIAL | open |
| 209949 · 001 · RLD | powder, intravenous | 350MG/VIAL | open |
| 210282 · 001 · RLD | powder, intravenous | 350MG/VIAL | 11 Sep 2033 |
| 210282 · 002 · RLD | powder, intravenous | 500MG/VIAL | 11 Sep 2033 |
| 217415 · 001 · RLD | powder, intravenous | 350MG/VIAL | 9 Jan 2043 |
| 217415 · 002 · RLD | powder, intravenous | 500MG/VIAL | 9 Jan 2043 |
| 217630 · 001 · RLD · discontinued | powder, intravenous | 350MG/VIAL | open |
| 217630 · 002 · RLD | powder, intravenous | 500MG/VIAL | open |