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FDA Orange Book · active-ingredient family

Linagliptin; metformin hydrochloride

Linagliptin; metformin hydrochloride is approved as 2 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:JENTADUETO XR · NDA 208026

2

Brand (NDA)

4

Generics (ANDA)

21

Listed patents

10

Exclusivity periods

Brand (NDA) products · tablet, tablet, extended release

ProductApplicantApplicationTEApproved
JENTADUETO XRRLD×2BOEHRINGER INGELHEIMNDA 208026—May 27, 2016
JENTADUETORLD×3BOEHRINGER INGELHEIMNDA 201281ABJan 30, 2012

Generic (ANDA) products (4)

ProductApplicantApplicationTEApproved
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE×3DR REDDYSANDA 208427ABNov 03, 2025
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE×3MSNANDA 208459ABNov 03, 2025
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE×3ZYDUS PHARMSANDA 208449ABMar 30, 2023
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE×3SUNSHINEANDA 208336ABAug 30, 2021

Marketing exclusivity (10)

  • 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

  • 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

  • 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

  • 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

  • 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 (21)

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
9173859May 04, 2027in 11 mo
ProductU-1503Delisted
8673927May 04, 2027in 11 mo
U-1503Delisted
9173859*PEDNov 04, 2027in 1 yr 5 mo
8673927*PEDNov 04, 2027in 1 yr 5 mo
10022379Apr 02, 2029in 2 yr 10 mo
U-2339
9415016Apr 02, 2029in 2 yr 10 mo
Product
10973827Apr 02, 2029in 2 yr 10 mo
Product
10022379*PEDOct 02, 2029in 3 yr 4 mo
9415016*PEDOct 02, 2029in 3 yr 4 mo
10973827*PEDOct 02, 2029in 3 yr 4 mo
11911388Apr 10, 2030in 3 yr 10 mo
U-3854
9155705May 21, 2030in 4 yr
Product
8846695Jun 04, 2030in 4 yr
U-1503Delisted
9155705*PEDNov 21, 2030in 4 yr 6 mo
8846695*PEDDec 04, 2030in 4 yr 6 mo
9555001Mar 06, 2033in 6 yr 10 mo
ProductU-1967
9555001*PEDSep 06, 2033in 7 yr 4 mo
12364700Jun 08, 2037in 11 yr 2 mo
U-4224
12364700*PEDDec 08, 2037in 11 yr 8 mo

Linagliptin; metformin hydrochloride — frequently asked questions

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

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