canagliflozin; metformin hydrochloride · Janssen Pharms · NDA 205879
Invokamet Xr
Earliest generic entry, as listed · earliest of 4 marketed strengths
26 Aug 2029
Blocked by patent: US 7943582 (pediatric extension).
Listed patents · 3 unexpired
10 Orange Book listing rows for 3 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 |
|---|---|---|
| US 7943582 | drug substance, drug product, use U-2441, U-2632, U-493 | 26 Aug 2029 |
| US 7943582 listing row | drug substance, drug product, use U-2441 | 26 Feb 2029 |
| US 7943582 listing row | drug substance, drug product, use U-2632 | 26 Feb 2029 |
| US 7943582 listing row | drug substance, drug product, use U-493 | 26 Feb 2029 |
| US 7943582 listing row | pediatric extension · sets the listed date | 26 Aug 2029 |
| US 8513202 | drug substance, drug product, use U-2441, U-2632, U-493 | 3 Jun 2028 |
| US 8513202 listing row | drug substance, drug product, use U-2441 | 3 Dec 2027 |
| US 8513202 listing row | drug substance, drug product, use U-2632 | 3 Dec 2027 |
| US 8513202 listing row | drug substance, drug product, use U-493 | 3 Dec 2027 |
| US 8513202 listing row | pediatric extension | 3 Jun 2028 |
| US 7943788 | drug substance, drug product | 14 Jan 2028 |
| US 7943788 listing row | drug substance, drug product | 14 Jul 2027 |
| US 7943788 listing row | pediatric extension | 14 Jan 2028 |
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 | Listed expiry |
|---|---|---|---|
| 205879 · 001 · RLD | tablet, extended release, oral | 50MG;500MG | 26 Aug 2029 |
| 205879 · 002 · RLD | tablet, extended release, oral | 50MG;1GM | 26 Aug 2029 |
| 205879 · 003 · RLD | tablet, extended release, oral | 150MG;500MG | 26 Aug 2029 |
| 205879 · 004 · RLD | tablet, extended release, oral | 150MG;1GM | 26 Aug 2029 |