empagliflozin; metformin hydrochloride · Boehringer Ingelheim · NDA 208658
Synjardy Xr
Earliest generic entry, as listed · earliest of 4 marketed strengths
11 Dec 2034
Blocked by patent: US 9949998.
Listed patents · 32 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-3533 | 17 May 2034 |
| US 9949997 | use U-3532 | 17 May 2034 |
| US 10258637 | use U-2290 | 3 Apr 2034 |
| US 11090323 | use U-3193 | 3 Apr 2034 |
| US 11666590 | use U-4154 | 3 Apr 2034 |
| US 11813275 | use U-3759 | 3 Apr 2034 |
| US 11833166 | use U-3777 | 3 Apr 2034 |
| US 11833166 | use U-3776 | 3 Apr 2034 |
| US 12263153 | use U-4154 | 3 Apr 2034 |
| US 12427162 | use U-4287 | 3 Apr 2034 |
| US 12433906 | use U-4296 | 3 Apr 2034 |
| US 12433906 | use U-4294 | 3 Apr 2034 |
| US 12433906 | use U-4304 | 3 Apr 2034 |
| US 12433906 | use U-4295 | 3 Apr 2034 |
| US 12433906 | use U-4293 | 3 Apr 2034 |
| US 10596120 | — | 7 Sep 2032 |
| US 10596120 | product, use U-2792 | 7 Mar 2032 |
| US 10596120 | product, use U-2775 | 7 Mar 2032 |
| US 12115179 | — | 11 Aug 2030 |
| US 12115179 | use U-4023 | 11 Feb 2030 |
| 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
- 24 Oct 2026Exclusivity expires within 90 days PED · 208658-00420 Dec 2026
- 24 Oct 2026Exclusivity expires within 90 days PED · 208658-00320 Dec 2026
- 24 Oct 2026Exclusivity expires within 90 days PED · 208658-00220 Dec 2026
- 24 Oct 2026Exclusivity expires within 90 days PED · 208658-00120 Dec 2026
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208658 · 001 · RLD | tablet, extended release, oral | 5MG;1GM | 11 Dec 2034 |
| 208658 · 002 · RLD | tablet, extended release, oral | 10MG;1GM | 11 Dec 2034 |
| 208658 · 003 · RLD | tablet, extended release, oral | 12.5MG;1GM | 11 Dec 2034 |
| 208658 · 004 · RLD | tablet, extended release, oral | 25MG;1GM | 11 Dec 2034 |
Expired or delisted (1)
- M-296 · 20 Jun 2026