metformin hydrochloride · Sun Pharm · NDA 212595

Riomet Er

Earliest generic entry, as listed
1 May 2035

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

Blocked by patent: US 9962336.

Listed patents · 1 unexpired

PatentClaimsExpires
US 9962336drug product · sets the listed date1 May 2035

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
212595 · 001 · RLD · discontinuedfor suspension, extended release, oral500MG/5ML1 May 2035