FDA Orange Book · active-ingredient family
Empagliflozin; metformin hydrochloride
Empagliflozin; metformin hydrochloride is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SYNJARDY XR · NDA 208658
2
Brand (NDA)
1
Generics (ANDA)
29
Listed patents
16
Exclusivity periods
Brand (NDA) products · tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SYNJARDY XRRLD×4 | BOEHRINGER INGELHEIM | NDA 208658 | — | Dec 09, 2016 | |
| SYNJARDYRLD×4 | BOEHRINGER INGELHEIM | NDA 206111 | — | Aug 26, 2015 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE×4 | ZYDUS PHARMS | ANDA 212198 | — | Jul 07, 2022 |
Marketing exclusivity (16)
- M-296New use / labeling-change exclusivity (3 years)
Jun 20, 2026
in 1 d
- PEDPediatric exclusivity (adds 6 months)
Dec 20, 2026
in 6 mo
- M-296New use / labeling-change exclusivity (3 years)
Jun 20, 2026
in 1 d
- PEDPediatric exclusivity (adds 6 months)
Dec 20, 2026
in 6 mo
- M-296New use / labeling-change exclusivity (3 years)
Jun 20, 2026
in 1 d
- PEDPediatric exclusivity (adds 6 months)
Dec 20, 2026
in 6 mo
- M-296New use / labeling-change exclusivity (3 years)
Jun 20, 2026
in 1 d
- PEDPediatric exclusivity (adds 6 months)
Dec 20, 2026
in 6 mo
- NPPNew patient population exclusivity (3 years)
Jun 20, 2026
in 1 d
- PEDPediatric exclusivity (adds 6 months)
Dec 20, 2026
in 6 mo
- NPPNew patient population exclusivity (3 years)
Jun 20, 2026
in 1 d
- PEDPediatric exclusivity (adds 6 months)
Dec 20, 2026
in 6 mo
- NPPNew patient population exclusivity (3 years)
Jun 20, 2026
in 1 d
- PEDPediatric exclusivity (adds 6 months)
Dec 20, 2026
in 6 mo
- NPPNew patient population exclusivity (3 years)
Jun 20, 2026
in 1 d
- PEDPediatric exclusivity (adds 6 months)
Dec 20, 2026
in 6 mo
Listed patents (29)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7713938 | Apr 15, 2027 | in 10 mo | SubstanceProduct |
| 7713938*PED | Oct 15, 2027 | in 1 yr 4 mo | |
| 7579449 | Aug 01, 2028 | in 2 yr 2 mo | Substance |
| 7579449*PED | Feb 01, 2029 | in 2 yr 8 mo | |
| 12115179 | Feb 11, 2030 | in 3 yr 8 mo | U-4023 |
| 12115179*PED | Aug 11, 2030 | in 4 yr 2 mo | |
| 10610489 | Sep 30, 2030 | in 4 yr 4 mo | Product |
| 10610489*PED | Mar 30, 2031 | in 4 yr 10 mo | |
| 10596120 | Mar 07, 2032 | in 5 yr 10 mo | ProductU-2775 |
| 10596120*PED | Sep 07, 2032 | in 6 yr 4 mo | |
| 12527810 | Apr 22, 2033 | in 6 yr 11 mo | U-4403 |
| 12527810*PED | Oct 22, 2033 | in 7 yr 5 mo | |
| 12433906 | Apr 03, 2034 | in 7 yr 11 mo | U-4304 |
| 11666590 | Apr 03, 2034 | in 7 yr 11 mo | U-4154 |
| 12263153 | Apr 03, 2034 | in 7 yr 11 mo | U-4154 |
| 12427162 | Apr 03, 2034 | in 7 yr 11 mo | U-4287 |
| 10258637 | Apr 03, 2034 | in 7 yr 11 mo | U-2290 |
| 11833166 | Apr 03, 2034 | in 7 yr 11 mo | U-3776 |
| 11090323 | Apr 03, 2034 | in 7 yr 11 mo | U-3193 |
| 11813275 | Apr 03, 2034 | in 7 yr 11 mo | U-3759 |
| 9949997 | May 17, 2034 | in 8 yr | U-3532 |
| 9949998 | Jun 11, 2034 | in 8 yr 1 mo | U-2290 |
| 10258637*PED | Oct 03, 2034 | in 8 yr 5 mo | |
| 11813275*PED | Oct 03, 2034 | in 8 yr 5 mo | |
| 11833166*PED | Oct 03, 2034 | in 8 yr 5 mo | |
| 11090323*PED | Oct 03, 2034 | in 8 yr 5 mo | |
| 12433906*PED | Oct 03, 2034 | in 8 yr 5 mo | |
| 9949997*PED | Nov 17, 2034 | in 8 yr 6 mo | |
| 9949998*PED | Dec 11, 2034 | in 8 yr 7 mo |
Empagliflozin; metformin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
