Orange Book product · Brand (NDA)
SYNJARDY XR
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
At a glance
Dec 09, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
32
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 09, 2016
9 yr 8 mo ago
Today
Exclusivity ends · M-296
New use / labeling-change 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 10596120 expires
Listed drug product patent expiration.
Mar 07, 2032
in 5 yr 10 mo
Patent 10596120 expires
Listed drug product patent expiration.
Mar 07, 2032
in 5 yr 10 mo
Patent 10596120*PED expires
Listed listed patent expiration.
Sep 07, 2032
in 6 yr 4 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-3776) 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 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 9949998 expires
Listed method-of-use patent (U-2290) expiration.
Jun 11, 2034
in 8 yr 1 mo
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
Patent 9949998*PED expires
Listed listed patent expiration.
Dec 11, 2034
in 8 yr 7 mo
Pharmaceutical detail
Active ingredient
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Strength
5MG;1GM
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 208658
Product number
001
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)
- 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
Listed patents (32)
| 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 | |
| 10596120 | Mar 07, 2032 | in 5 yr 10 mo | ProductU-2775 |
| 10596120 | Mar 07, 2032 | in 5 yr 10 mo | ProductU-2792 |
| 10596120*PED | Sep 07, 2032 | in 6 yr 4 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-3776 |
| 11833166 | Apr 03, 2034 | in 7 yr 11 mo | U-3777 |
| 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 |
| 9949998 | Jun 11, 2034 | in 8 yr 1 mo | U-2290 |
| 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 | |
| 9949998*PED | Dec 11, 2034 | in 8 yr 7 mo |
