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FDA Orange Book · active-ingredient family

Empagliflozin

Empagliflozin is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:JARDIANCE · NDA 204629

1

Brand (NDA)

1

Generics (ANDA)

27

Listed patents

5

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
JARDIANCERLD×2BOEHRINGER INGELHEIMNDA 204629—Aug 01, 2014

Generic (ANDA) products (1)

ProductApplicantApplicationTEApproved
EMPAGLIFLOZIN×2ZYDUS PHARMSANDA 212138—Aug 03, 2022

Marketing exclusivity (5)

  • I-922New indication exclusivity (3 years)

    Sep 21, 2026

    in 3 mo

  • NPPNew patient population exclusivity (3 years)

    Jun 20, 2026

    in 1 d

  • PEDPediatric exclusivity (adds 6 months)

    Dec 20, 2026

    in 6 mo

  • 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 (27)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7713938Apr 15, 2027in 10 mo
SubstanceProduct
7713938*PEDOct 15, 2027in 1 yr 4 mo
7579449Aug 01, 2028in 2 yr 2 mo
Substance
7579449*PEDFeb 01, 2029in 2 yr 8 mo
8551957Oct 14, 2029in 3 yr 4 mo
U-1651
12115179Feb 11, 2030in 3 yr 8 mo
U-4023
8551957*PEDApr 14, 2030in 3 yr 11 mo
12115179*PEDAug 11, 2030in 4 yr 2 mo
12527810Apr 22, 2033in 6 yr 11 mo
U-4403
12527810*PEDOct 22, 2033in 7 yr 5 mo
10258637Apr 03, 2034in 7 yr 11 mo
U-2290
11090323Apr 03, 2034in 7 yr 11 mo
U-3191
12433906Apr 03, 2034in 7 yr 11 mo
U-4304
12263153Apr 03, 2034in 7 yr 11 mo
U-4171
12427162Apr 03, 2034in 7 yr 11 mo
U-4287
11666590Apr 03, 2034in 7 yr 11 mo
U-3691
11833166Apr 03, 2034in 7 yr 11 mo
U-3776
11813275Apr 03, 2034in 7 yr 11 mo
U-3759
9949997May 17, 2034in 8 yr
U-2292
9949998Jun 11, 2034in 8 yr 1 mo
U-2290
10258637*PEDOct 03, 2034in 8 yr 5 mo
11813275*PEDOct 03, 2034in 8 yr 5 mo
11833166*PEDOct 03, 2034in 8 yr 5 mo
11090323*PEDOct 03, 2034in 8 yr 5 mo
12433906*PEDOct 03, 2034in 8 yr 5 mo
9949997*PEDNov 17, 2034in 8 yr 6 mo
9949998*PEDDec 11, 2034in 8 yr 7 mo

Empagliflozin — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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