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FDA Orange Book · active-ingredient family

Linagliptin

Linagliptin is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TRADJENTA · NDA 201280

1

Brand (NDA)

8

Generics (ANDA)

18

Listed patents

2

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
TRADJENTARLDBOEHRINGER INGELHEIMNDA 201280ABMay 02, 2011

Generic (ANDA) products (8)

ProductApplicantApplicationTEApproved
LINAGLIPTINTEVA PHARMS USAANDA 208433ABMay 27, 2026
LINAGLIPTINAUROBINDO PHARMA LTDANDA 208415ABNov 03, 2025
LINAGLIPTINDR REDDYSANDA 208428ABNov 03, 2025
LINAGLIPTINMSNANDA 208457ABNov 03, 2025
LINAGLIPTINMYLANANDA 208431ABNov 03, 2025
LINAGLIPTININVAGEN PHARMSANDA 208423ABSep 03, 2024
LINAGLIPTINZYDUS PHARMSANDA 208448ABMar 30, 2023
LINAGLIPTINSUNSHINEANDA 208335ABAug 31, 2021

Marketing exclusivity (2)

  • M-295New 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 (18)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8883805Nov 26, 20257 mo ago
Product
8883805*PEDMay 26, 202624 d ago
8673927May 04, 2027in 11 mo
U-1503Delisted
12178819May 04, 2027in 11 mo
Product
11033552May 04, 2027in 11 mo
Product
8673927*PEDNov 04, 2027in 1 yr 5 mo
11033552*PEDNov 04, 2027in 1 yr 5 mo
9486526Aug 05, 2029in 3 yr 2 mo
U-1915
10034877Aug 05, 2029in 3 yr 2 mo
U-2347
10034877*PEDFeb 05, 2030in 3 yr 8 mo
9486526*PEDFeb 05, 2030in 3 yr 8 mo
11911388Apr 10, 2030in 3 yr 10 mo
U-3854
8846695Jun 04, 2030in 4 yr
U-1503Delisted
8846695*PEDDec 04, 2030in 4 yr 6 mo
8853156Mar 05, 2031in 4 yr 9 mo
ProductU-1642
8853156*PEDSep 05, 2031in 5 yr 3 mo
12364700Jun 08, 2037in 11 yr 2 mo
U-4224
12364700*PEDDec 08, 2037in 11 yr 8 mo

Linagliptin — frequently asked questions

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

Agent CTA Background

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