daptomycin · Baxter Hlthcare Corp · NDA 213645

Dapzura Rt

Earliest generic entry, as listed
11 Mar 2041

No marketed reference-listed strength; date taken from all listed strengths.

Blocked by patent: US 11173189.

Listed patents · 1 unexpired

PatentClaimsExpires
US 11173189drug product, use U-3294 · sets the listed date11 Mar 2041

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 · 1

NDA · productFormStrengthListed expiry
213645 · 001 · RLD · discontinuedpowder, intravenous500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**11 Mar 2041