Orange Book product · Brand (NDA)
SYNJARDY
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
At a glance
Aug 26, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
31
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 26, 2015
11 yr ago
Today
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Jun 20, 2026
in 1 d
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Dec 20, 2026
in 6 mo
Patent 7713938 expires
Listed drug substance patent expiration.
Apr 15, 2027
in 10 mo
Patent 7713938*PED expires
Listed listed patent expiration.
Oct 15, 2027
in 1 yr 4 mo
Patent 7579449 expires
Listed drug substance patent expiration.
Aug 01, 2028
in 2 yr 2 mo
Patent 7579449*PED expires
Listed listed patent expiration.
Feb 01, 2029
in 2 yr 8 mo
Patent 12115179 expires
Listed method-of-use patent (U-4023) expiration.
Feb 11, 2030
in 3 yr 8 mo
Patent 12115179*PED expires
Listed listed patent expiration.
Aug 11, 2030
in 4 yr 2 mo
Patent 10610489 expires
Listed drug product patent expiration.
Sep 30, 2030
in 4 yr 4 mo
Patent 10610489*PED expires
Listed listed patent expiration.
Mar 30, 2031
in 4 yr 10 mo
Patent 12527810 expires
Listed method-of-use patent (U-4403) expiration.
Apr 22, 2033
in 6 yr 11 mo
Patent 12527810*PED expires
Listed listed patent expiration.
Oct 22, 2033
in 7 yr 5 mo
Patent 10258637 expires
Listed method-of-use patent (U-2290) expiration.
Apr 03, 2034
in 7 yr 11 mo
Patent 11090323 expires
Listed method-of-use patent (U-3193) expiration.
Apr 03, 2034
in 7 yr 11 mo
Patent 11666590 expires
Listed method-of-use patent (U-4154) expiration.
Apr 03, 2034
in 7 yr 11 mo
Patent 11813275 expires
Listed method-of-use patent (U-3759) expiration.
Apr 03, 2034
in 7 yr 11 mo
Patent 11833166 expires
Listed method-of-use patent (U-3777) expiration.
Apr 03, 2034
in 7 yr 11 mo
Patent 11833166 expires
Listed method-of-use patent (U-3776) expiration.
Apr 03, 2034
in 7 yr 11 mo
Patent 12263153 expires
Listed method-of-use patent (U-4154) expiration.
Apr 03, 2034
in 7 yr 11 mo
Patent 12427162 expires
Listed method-of-use patent (U-4287) expiration.
Apr 03, 2034
in 7 yr 11 mo
Patent 12433906 expires
Listed method-of-use patent (U-4304) expiration.
Apr 03, 2034
in 7 yr 11 mo
Patent 12433906 expires
Listed method-of-use patent (U-4293) expiration.
Apr 03, 2034
in 7 yr 11 mo
Patent 12433906 expires
Listed method-of-use patent (U-4294) expiration.
Apr 03, 2034
in 7 yr 11 mo
Patent 12433906 expires
Listed method-of-use patent (U-4295) expiration.
Apr 03, 2034
in 7 yr 11 mo
Patent 12433906 expires
Listed method-of-use patent (U-4296) expiration.
Apr 03, 2034
in 7 yr 11 mo
Patent 9949997 expires
Listed method-of-use patent (U-3532) expiration.
May 17, 2034
in 8 yr
Patent 9949997 expires
Listed method-of-use patent (U-3533) expiration.
May 17, 2034
in 8 yr
Patent 10258637*PED expires
Listed listed patent expiration.
Oct 03, 2034
in 8 yr 5 mo
Patent 11090323*PED expires
Listed listed patent expiration.
Oct 03, 2034
in 8 yr 5 mo
Patent 11813275*PED expires
Listed listed patent expiration.
Oct 03, 2034
in 8 yr 5 mo
Patent 11833166*PED expires
Listed listed patent expiration.
Oct 03, 2034
in 8 yr 5 mo
Patent 12433906*PED expires
Listed listed patent expiration.
Oct 03, 2034
in 8 yr 5 mo
Patent 9949997*PED expires
Listed listed patent expiration.
Nov 17, 2034
in 8 yr 6 mo
Pharmaceutical detail
Active ingredient
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Strength
5MG;1GM
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 206111
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- 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 (31)
| 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 | |
| 12527810 | Apr 22, 2033 | in 6 yr 11 mo | U-4403 |
| 12527810*PED | Oct 22, 2033 | in 7 yr 5 mo | |
| 10258637 | Apr 03, 2034 | in 7 yr 11 mo | U-2290 |
| 11090323 | Apr 03, 2034 | in 7 yr 11 mo | U-3193 |
| 11666590 | Apr 03, 2034 | in 7 yr 11 mo | U-4154 |
| 11813275 | Apr 03, 2034 | in 7 yr 11 mo | U-3759 |
| 11833166 | Apr 03, 2034 | in 7 yr 11 mo | U-3777 |
| 11833166 | Apr 03, 2034 | in 7 yr 11 mo | U-3776 |
| 12263153 | Apr 03, 2034 | in 7 yr 11 mo | U-4154 |
| 12427162 | Apr 03, 2034 | in 7 yr 11 mo | U-4287 |
| 12433906 | Apr 03, 2034 | in 7 yr 11 mo | U-4304 |
| 12433906 | Apr 03, 2034 | in 7 yr 11 mo | U-4293 |
| 12433906 | Apr 03, 2034 | in 7 yr 11 mo | U-4294 |
| 12433906 | Apr 03, 2034 | in 7 yr 11 mo | U-4295 |
| 12433906 | Apr 03, 2034 | in 7 yr 11 mo | U-4296 |
| 9949997 | May 17, 2034 | in 8 yr | U-3532 |
| 9949997 | May 17, 2034 | in 8 yr | U-3533 |
| 10258637*PED | Oct 03, 2034 | in 8 yr 5 mo | |
| 11090323*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 | |
| 12433906*PED | Oct 03, 2034 | in 8 yr 5 mo | |
| 9949997*PED | Nov 17, 2034 | in 8 yr 6 mo |
