canagliflozin · Janssen Pharms · NDA 204042
Invokana
Blocked by patent: US 7943582 (pediatric extension).
FDA has approved 2 generic applications (ANDAs) for Invokana, though its earliest generic-entry date is 26 Aug 2029 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
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
- First generic approved · ANDA 210449, Apotex · 204042-001Approved 14 Apr 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 210449, Apotex · 204042-001Approved 14 Apr 2026Detected 25 Oct 2026Historical import
- Generic tentatively approved · ANDA 210451, Teva Pharms Usa · 204042-001Tentative approval 21 Jul 2026Detected 25 Oct 2026Historical import
- Generic tentatively approved · ANDA 210503, Laurus Labs Ltd · 204042-001Tentative approval 29 Sep 2025Detected 25 Oct 2026Historical import
- Generic approved · ANDA 210386, Aurobindo Pharma Ltd · 204042-001Approved 20 Apr 2026Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204042 · 001 · RLD | tablet, oral | 100MG | 26 Aug 2029 |
| 204042 · 002 · RLD | tablet, oral | 300MG | 26 Aug 2029 |