meloxicam · Baudax · NDA 210583

Anjeso

Earliest generic entry, as listed
8 Mar 2039

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

Blocked by patent: US 10881663, US 11458145. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 5 unexpired

PatentClaimsExpires
US 10881663use U-30388 Mar 2039
US 11458145use U-33188 Mar 2039
US 10709713use U-275026 May 2030
US 11253478product, use U-331826 May 2030
US 9974746product26 May 2030

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
210583 · 001 · RLD · discontinuedsolution, intravenous30MG/ML (30MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**8 Mar 2039