daptomycin · Cubist Pharms Llc · NDA 021572
Cubicin
Earliest generic entry, as listed
4 Sep 2028
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8003673. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8003673 | use U-1180 · sets the listed date | 4 Sep 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 |
|---|---|---|---|
| 021572 · 001 · discontinued | powder, intravenous | 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 021572 · 002 · RLD · discontinued | powder, intravenous | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 4 Sep 2028 |