empagliflozin · Boehringer Ingelheim · NDA 204629
Jardiance
Earliest generic entry, as listed · earliest of 2 marketed strengths
11 Dec 2034
Blocked by patent: US 9949998.
Listed patents · 35 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9949998 | — | 11 Dec 2034 |
| US 9949997 | — | 17 Nov 2034 |
| US 10258637 | — | 3 Oct 2034 |
| US 11090323 | — | 3 Oct 2034 |
| US 11813275 | — | 3 Oct 2034 |
| US 11833166 | — | 3 Oct 2034 |
| US 12433906 | — | 3 Oct 2034 |
| US 9949998 | use U-2290 | 11 Jun 2034 |
| US 9949997 | use U-3199 | 17 May 2034 |
| US 9949997 | use U-2292 | 17 May 2034 |
| US 9949997 | use U-3325 | 17 May 2034 |
| US 10258637 | use U-2290 | 3 Apr 2034 |
| US 11090323 | use U-3191 | 3 Apr 2034 |
| US 11666590 | use U-3691 | 3 Apr 2034 |
| US 11813275 | use U-3759 | 3 Apr 2034 |
| US 11813275 | use U-3760 | 3 Apr 2034 |
| US 11833166 | use U-3776 | 3 Apr 2034 |
| US 11833166 | use U-3777 | 3 Apr 2034 |
| US 12263153 | use U-4171 | 3 Apr 2034 |
| US 12427162 | use U-4287 | 3 Apr 2034 |
| US 12433906 | use U-4294 | 3 Apr 2034 |
| US 12433906 | use U-4295 | 3 Apr 2034 |
| US 12433906 | use U-4296 | 3 Apr 2034 |
| US 12433906 | use U-4293 | 3 Apr 2034 |
| US 12433906 | use U-4304 | 3 Apr 2034 |
| US 12527810 | — | 22 Oct 2033 |
| US 12527810 | use U-4403 | 22 Apr 2033 |
| US 12115179 | — | 11 Aug 2030 |
| US 8551957 | — | 14 Apr 2030 |
| US 12115179 | use U-4023 | 11 Feb 2030 |
| US 8551957 | use U-1651 | 14 Oct 2029 |
| US 7579449 | — | 1 Feb 2029 |
| US 7579449 | substance | 1 Aug 2028 |
| US 7713938 | — | 15 Oct 2027 |
| US 7713938 | substance, product | 15 Apr 2027 |
Exclusivities · 1 unexpired
| PED | pediatric (6 months added) | 20 Dec 2026 |
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
- 25 Oct 2026Generic tentatively approved · 204629-00121 May 2026
- 25 Oct 2026Generic approved · 204629-00122 Sep 2026
- 24 Oct 2026Exclusivity expires within 90 days PED · 204629-00220 Dec 2026
- 24 Oct 2026Exclusivity expires within 90 days PED · 204629-00120 Dec 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204629 · 001 · RLD | tablet, oral | 10MG | 11 Dec 2034 |
| 204629 · 002 · RLD | tablet, oral | 25MG | 11 Dec 2034 |
Expired or delisted (2)
- I-922 · 21 Sep 2026
- NPP · 20 Jun 2026