FDA Orange Book

Generic for Jardiance

Jardiance contains empagliflozin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Jardiance is empagliflozin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

Run it in Rivvi

Map Jardiance and your other top fills to their generics

Every strength in RxNorm, with brands that have no generic flagged.

Build the map

Free to start. Opens Rivvi, the AI workspace for healthcare teams.

Jardiance products in the Orange Book

Jardiance products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	10MG	Marketed (Rx)	AB	1	AB
tablet, oral	25MG	Marketed (Rx)	AB	1	AB

NDA 204629, 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.

Approved generic empagliflozin

Approved generic versions of Jardiance
Company	ANDA	TE code	Approved	Strengths
INVAGEN PHARMACEUTICALS INC	212330	AB (A-rated, therapeutically equivalent)	September 22, 2026	10MG, 25MG

Jardiance patents

Patents listed for Jardiance
Patent	Expires	Covers	Use code	NDA
7713938	April 15, 2027	Drug substance, Drug product	None	204629
7713938*PED	October 15, 2027	Method of use	None	204629
7579449	August 1, 2028	Drug substance	None	204629
7579449*PED	February 1, 2029	Method of use	None	204629
8551957	October 14, 2029	Method of use	U-1651	204629
12115179	February 11, 2030	Method of use	U-4023	204629
8551957*PED	April 14, 2030	Method of use	None	204629
12115179*PED	August 11, 2030	Method of use	None	204629
12527810	April 22, 2033	Method of use	U-4403	204629
12527810*PED	October 22, 2033	Method of use	None	204629
10258637	April 3, 2034	Method of use	U-2290	204629
11090323	April 3, 2034	Method of use	U-3191	204629
12433906	April 3, 2034	Method of use	U-4304	204629
12263153	April 3, 2034	Method of use	U-4171	204629
12433906	April 3, 2034	Method of use	U-4293	204629
12433906	April 3, 2034	Method of use	U-4294	204629
12433906	April 3, 2034	Method of use	U-4295	204629
12433906	April 3, 2034	Method of use	U-4296	204629
12427162	April 3, 2034	Method of use	U-4287	204629
11666590	April 3, 2034	Method of use	U-3691	204629
11833166	April 3, 2034	Method of use	U-3776	204629
11833166	April 3, 2034	Method of use	U-3777	204629
11813275	April 3, 2034	Method of use	U-3759	204629
11813275	April 3, 2034	Method of use	U-3760	204629
9949997	May 17, 2034	Method of use	U-2292	204629
9949997	May 17, 2034	Method of use	U-3325	204629
9949997	May 17, 2034	Method of use	U-3199	204629
9949998	June 11, 2034	Method of use	U-2290	204629
10258637*PED	October 3, 2034	Method of use	None	204629
11813275*PED	October 3, 2034	Method of use	None	204629
11833166*PED	October 3, 2034	Method of use	None	204629
11090323*PED	October 3, 2034	Method of use	None	204629
12433906*PED	October 3, 2034	Method of use	None	204629
9949997*PED	November 17, 2034	Method of use	None	204629
9949998*PED	December 11, 2034	Method of use	None	204629

Jardiance exclusivity

Exclusivity listed for Jardiance
Code	Meaning	Expires	NDA
NPP	New patient population	June 20, 2026	204629
I-922	New indication	September 21, 2026	204629
PED	Pediatric exclusivity	December 20, 2026	204629

Jardiance NDC codes

Questions

Is there a generic for Jardiance?

Yes. The generic name for Jardiance is empagliflozin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Jardiance?

The active ingredient in Jardiance is empagliflozin, per the FDA Orange Book.

When does the Jardiance patent expire?

The last patent listed for Jardiance in the Orange Book expires December 11, 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.