empagliflozin; metformin hydrochloride · Boehringer Ingelheim · NDA 206111
Synjardy
Earliest generic entry, as listed · earliest of 4 marketed strengths
17 Nov 2034
Blocked by patent: US 9949997 (pediatric extension).
Listed patents · 14 unexpired
31 Orange Book listing rows for 14 patents, including 11 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9949997 | use U-3532, U-3533 | 17 Nov 2034 |
| US 9949997 listing row | use U-3532 | 17 May 2034 |
| US 9949997 listing row | use U-3533 | 17 May 2034 |
| US 9949997 listing row | pediatric extension · sets the listed date | 17 Nov 2034 |
| US 10258637 | use U-2290 | 3 Oct 2034 |
| US 10258637 listing row | use U-2290 | 3 Apr 2034 |
| US 10258637 listing row | pediatric extension | 3 Oct 2034 |
| US 11090323 | use U-3193 | 3 Oct 2034 |
| US 11090323 listing row | use U-3193 | 3 Apr 2034 |
| US 11090323 listing row | pediatric extension | 3 Oct 2034 |
| US 11813275 | use U-3759 | 3 Oct 2034 |
| US 11813275 listing row | use U-3759 | 3 Apr 2034 |
| US 11813275 listing row | pediatric extension | 3 Oct 2034 |
| US 11833166 | use U-3776, U-3777 | 3 Oct 2034 |
| US 11833166 listing row | use U-3776 | 3 Apr 2034 |
| US 11833166 listing row | use U-3777 | 3 Apr 2034 |
| US 11833166 listing row | pediatric extension | 3 Oct 2034 |
| US 12433906 | use U-4293, U-4294, U-4295, U-4296, U-4304 | 3 Oct 2034 |
| US 12433906 listing row | use U-4293 | 3 Apr 2034 |
| US 12433906 listing row | use U-4294 | 3 Apr 2034 |
| US 12433906 listing row | use U-4295 | 3 Apr 2034 |
| US 12433906 listing row | use U-4296 | 3 Apr 2034 |
| US 12433906 listing row | use U-4304 | 3 Apr 2034 |
| US 12433906 listing row | pediatric extension | 3 Oct 2034 |
| US 11666590 | use U-4154 | 3 Apr 2034 |
| US 12263153 | use U-4154 | 3 Apr 2034 |
| US 12427162 | use U-4287 | 3 Apr 2034 |
| US 12527810 | use U-4403 | 22 Oct 2033 |
| US 12527810 listing row | use U-4403 | 22 Apr 2033 |
| US 12527810 listing row | pediatric extension | 22 Oct 2033 |
| US 10610489 | drug product | 30 Mar 2031 |
| US 10610489 listing row | drug product | 30 Sep 2030 |
| US 10610489 listing row | pediatric extension | 30 Mar 2031 |
| US 12115179 | use U-4023 | 11 Aug 2030 |
| US 12115179 listing row | use U-4023 | 11 Feb 2030 |
| US 12115179 listing row | pediatric extension | 11 Aug 2030 |
| US 7579449 | drug substance | 1 Feb 2029 |
| US 7579449 listing row | drug substance | 1 Aug 2028 |
| US 7579449 listing row | pediatric extension | 1 Feb 2029 |
| US 7713938 | drug substance, drug product | 15 Oct 2027 |
| US 7713938 listing row | drug substance, drug product | 15 Apr 2027 |
| US 7713938 listing row | pediatric extension | 15 Oct 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
- Exclusivity expires within 90 days PED · 206111-003Exclusivity expires 20 Dec 2026Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 206111-004Exclusivity expires 20 Dec 2026Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 206111-001Exclusivity expires 20 Dec 2026Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 206111-002Exclusivity expires 20 Dec 2026Detected 24 Oct 2026
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 206111 · 001 · RLD | tablet, oral | 5MG;500MG | 17 Nov 2034 |
| 206111 · 002 · RLD | tablet, oral | 5MG;1GM | 17 Nov 2034 |
| 206111 · 003 · RLD | tablet, oral | 12.5MG;500MG | 17 Nov 2034 |
| 206111 · 004 · RLD | tablet, oral | 12.5MG;1GM | 17 Nov 2034 |
Expired or delisted (1)
- NPP · 20 Jun 2026