cliffwatch

canagliflozin; metformin hydrochloride · Janssen Pharms · NDA 204353

Invokamet

Earliest generic entry, as listed · earliest of 4 marketed strengths
6 Jul 2030

Blocked by patent: US 11576894.

Listed patents · 11 unexpired

PatentClaimsExpires
US 11576894product6 Jul 2030
US 7943582—26 Aug 2029
US 7943582substance, product, use U-263226 Feb 2029
US 7943582substance, product, use U-244126 Feb 2029
US 7943582substance, product, use U-49326 Feb 2029
US 8513202—3 Jun 2028
US 7943788—14 Jan 2028
US 8513202substance, product, use U-26323 Dec 2027
US 8513202substance, product, use U-24413 Dec 2027
US 8513202substance, product, use U-4933 Dec 2027
US 7943788substance, product14 Jul 2027

Exclusivities · 2 unexpired

PEDpediatric (6 months added)18 Jun 2028
NPPnew patient population18 Dec 2027

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 · 4

NDA · productFormStrengthListed expiry
204353 · 001 · RLDtablet, oral50MG;500MG6 Jul 2030
204353 · 002 · RLDtablet, oral50MG;1GM6 Jul 2030
204353 · 003 · RLDtablet, oral150MG;500MG6 Jul 2030
204353 · 004 · RLDtablet, oral150MG;1GM6 Jul 2030