Is there a generic for Empagliflozin?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Empagliflozin, referencing the brand JARDIANCE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Empagliflozin?

JARDIANCE (NDA 204629, BOEHRINGER INGELHEIM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Empagliflozin?

The Orange Book lists 27 patents against Empagliflozin products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Empagliflozin have FDA marketing exclusivity?

Yes. The Orange Book records 5 marketing-exclusivity periods for Empagliflozin. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Empagliflozin are approved?

Empagliflozin is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Empagliflozin

Empagliflozin: 1 brand, 1 generic; first approved Aug 01, 2014; generic available.

Generic available5 exclusivity periodsHas discontinued products

Generic status & protection

Generic available — 1 ANDA application approved.

Earliest patent expiry Apr 15, 2027Latest exclusivity ends Dec 20, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Apr 15, 2027

in 9 mo

Originator applications

Brand (NDA) products

JARDIANCERLD

BOEHRINGER INGELHEIMNDA 20462920142 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	—
25MG	TABLET	ORAL	Rx	—

Abbreviated applications

Generic (ANDA) products (1)

EMPAGLIFLOZIN

ZYDUS PHARMSANDA 21213820222 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—
25MG	TABLET	ORAL	Discontinued	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (5)

I-922New indication exclusivity (3 years)
Sep 21, 2026
in 2 mo
NPPNew patient population exclusivity (3 years)
Jun 20, 2026
21 d ago
PEDPediatric exclusivity (adds 6 months)
Dec 20, 2026
in 5 mo
NPPNew patient population exclusivity (3 years)
Jun 20, 2026
21 d ago
PEDPediatric exclusivity (adds 6 months)
Dec 20, 2026
in 5 mo

Orange Book patent file

Listed patents

Listed patents (27)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7713938	Apr 15, 2027	in 9 mo	SubstanceProduct
7713938*PED	Oct 15, 2027	in 1 yr 3 mo
7579449	Aug 01, 2028	in 2 yr 1 mo	Substance
7579449*PED	Feb 01, 2029	in 2 yr 7 mo
8551957	Oct 14, 2029	in 3 yr 4 mo	U-1651
12115179	Feb 11, 2030	in 3 yr 8 mo	U-4023
8551957*PED	Apr 14, 2030	in 3 yr 10 mo
12115179*PED	Aug 11, 2030	in 4 yr 2 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 10 mo	U-2290
11090323	Apr 03, 2034	in 7 yr 10 mo	U-3191
12433906	Apr 03, 2034	in 7 yr 10 mo	U-4304
12263153	Apr 03, 2034	in 7 yr 10 mo	U-4171
12427162	Apr 03, 2034	in 7 yr 10 mo	U-4287
11666590	Apr 03, 2034	in 7 yr 10 mo	U-3691
11833166	Apr 03, 2034	in 7 yr 10 mo	U-3776
11813275	Apr 03, 2034	in 7 yr 10 mo	U-3759
9949997	May 17, 2034	in 8 yr	U-2292
9949998	Jun 11, 2034	in 8 yr	U-2290
10258637*PED	Oct 03, 2034	in 8 yr 4 mo
11813275*PED	Oct 03, 2034	in 8 yr 4 mo
11833166*PED	Oct 03, 2034	in 8 yr 4 mo
11090323*PED	Oct 03, 2034	in 8 yr 4 mo
12433906*PED	Oct 03, 2034	in 8 yr 4 mo
9949997*PED	Nov 17, 2034	in 8 yr 6 mo
9949998*PED	Dec 11, 2034	in 8 yr 7 mo

FDA approval span

Approval history

First approval

Aug 01, 2014

12 yr 1 mo ago

Most recent approval

Aug 03, 2022

4 yr ago

Approvals span 2014–2022 across 2 FDA applications.

Brand (NDA) 150%

Generic (ANDA) 150%

Empagliflozin — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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