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 · 4 unexpired

11 Orange Book listing rows for 4 patents, including 3 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

Patent	Claims	Expires	Notes
US 11576894	drug product · sets the listed date	6 Jul 2030	4 strengths · listed 13 Mar 2023
US 7943582	drug substance, drug product, use U-2441, U-2632, U-493	26 Aug 2029	4 listing rows
US 7943582 listing row	drug substance, drug product, use U-2441	26 Feb 2029	4 strengths · listed 4 Sep 2014
US 7943582 listing row	drug substance, drug product, use U-2632	26 Feb 2029	4 strengths · listed 4 Sep 2014
US 7943582 listing row	drug substance, drug product, use U-493	26 Feb 2029	4 strengths · listed 4 Sep 2014
US 7943582 listing row	pediatric extension	26 Aug 2029	4 strengths
US 8513202	drug substance, drug product, use U-2441, U-2632, U-493	3 Jun 2028	4 listing rows
US 8513202 listing row	drug substance, drug product, use U-2441	3 Dec 2027	4 strengths · listed 4 Sep 2014
US 8513202 listing row	drug substance, drug product, use U-2632	3 Dec 2027	4 strengths · listed 4 Sep 2014
US 8513202 listing row	drug substance, drug product, use U-493	3 Dec 2027	4 strengths · listed 4 Sep 2014
US 8513202 listing row	pediatric extension	3 Jun 2028	4 strengths
US 7943788	drug substance, drug product	14 Jan 2028	2 listing rows
US 7943788 listing row	drug substance, drug product	14 Jul 2027	4 strengths · listed 4 Sep 2014
US 7943788 listing row	pediatric extension	14 Jan 2028	4 strengths

Exclusivities · 2 unexpired

PED	pediatric (6 months added)	18 Jun 2028
NPP	new patient population	18 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 · product	Form	Strength	Approved	Listed expiry
204353 · 001 · RLD	tablet, oral	50MG;500MG	8 Aug 2014	6 Jul 2030
204353 · 002 · RLD	tablet, oral	50MG;1GM	8 Aug 2014	6 Jul 2030
204353 · 003 · RLD	tablet, oral	150MG;500MG	8 Aug 2014	6 Jul 2030
204353 · 004 · RLD	tablet, oral	150MG;1GM	8 Aug 2014	6 Jul 2030