fosfomycin disodium · Meitheal · NDA 212271

Contepo

Earliest generic entry, as listed
30 Jan 2039

Blocked by patent: US 11541064, US 12702676. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 4 unexpired

PatentClaimsExpires
US 11541064use U-433130 Jan 2039
US 12702676use U-433130 Jan 2039
US 9345717use U-433227 Oct 2034
US 10086006use U-433212 Oct 2034

Exclusivities · 2 unexpired

GAINqualified infectious disease product22 Oct 2033
NPnew product22 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 · 1

NDA · productFormStrengthListed expiry
212271 · 001 · RLDpowder, intravenousEQ 6GM BASE/VIAL30 Jan 2039