Is There a Generic for Synjardy?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Synjardy (empagliflozin and metformin). The Orange Book shows its last listed patent expires November 17, 2034 and its last listed exclusivity ends December 20, 2026.

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Synjardy products in the Orange Book

Synjardy products and approved generics
Form and route	Strength	Brand status	Brand TE	Generic TE codes
tablet, oral	12.5MG;1GM	Marketed (Rx)	None	None
tablet, oral	12.5MG;500MG	Marketed (Rx)	None	None
tablet, oral	5MG;1GM	Marketed (Rx)	None	None
tablet, oral	5MG;500MG	Marketed (Rx)	None	None

NDA 206111, held by BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Synjardy patents

Patents listed for Synjardy
Patent	Expires	Covers	Use code	NDA
7713938	April 15, 2027	Drug substance, Drug product	None	206111
7713938*PED	October 15, 2027	Method of use	None	206111
7579449	August 1, 2028	Drug substance	None	206111
7579449*PED	February 1, 2029	Method of use	None	206111
12115179	February 11, 2030	Method of use	U-4023	206111
12115179*PED	August 11, 2030	Method of use	None	206111
10610489	September 30, 2030	Drug product	None	206111
10610489*PED	March 30, 2031	Method of use	None	206111
12527810	April 22, 2033	Method of use	U-4403	206111
12527810*PED	October 22, 2033	Method of use	None	206111
12433906	April 3, 2034	Method of use	U-4304	206111
11666590	April 3, 2034	Method of use	U-4154	206111
12263153	April 3, 2034	Method of use	U-4154	206111
12433906	April 3, 2034	Method of use	U-4293	206111
12433906	April 3, 2034	Method of use	U-4294	206111
12433906	April 3, 2034	Method of use	U-4295	206111
12433906	April 3, 2034	Method of use	U-4296	206111
12427162	April 3, 2034	Method of use	U-4287	206111
10258637	April 3, 2034	Method of use	U-2290	206111
11833166	April 3, 2034	Method of use	U-3777	206111
11833166	April 3, 2034	Method of use	U-3776	206111
11090323	April 3, 2034	Method of use	U-3193	206111
11813275	April 3, 2034	Method of use	U-3759	206111
9949997	May 17, 2034	Method of use	U-3532	206111
9949997	May 17, 2034	Method of use	U-3533	206111
10258637*PED	October 3, 2034	Method of use	None	206111
11813275*PED	October 3, 2034	Method of use	None	206111
12433906*PED	October 3, 2034	Method of use	None	206111
11833166*PED	October 3, 2034	Method of use	None	206111
11090323*PED	October 3, 2034	Method of use	None	206111
9949997*PED	November 17, 2034	Method of use	None	206111

Synjardy exclusivity

Exclusivity listed for Synjardy
Code	Meaning	Expires	NDA
NPP	New patient population	June 20, 2026	206111
PED	Pediatric exclusivity	December 20, 2026	206111

Synjardy NDC codes

Questions

Is there a generic for Synjardy?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Synjardy (empagliflozin and metformin). The Orange Book shows its last listed patent expires November 17, 2034 and its last listed exclusivity ends December 20, 2026.

What is the generic name for Synjardy?

The active ingredient in Synjardy is empagliflozin and metformin, per the FDA Orange Book.

When does the Synjardy patent expire?

The last patent listed for Synjardy in the Orange Book expires November 17, 2034. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.