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FDA Orange Book · active-ingredient family

Nintedanib esylate

Nintedanib esylate is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:OFEV · NDA 205832

1

Brand (NDA)

5

Generics (ANDA)

8

Listed patents

4

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
OFEVRLD×2BOEHRINGER INGELHEIMNDA 205832ABOct 15, 2014

Generic (ANDA) products (5)

ProductApplicantApplicationTEApproved
NINTEDANIB ESYLATE×2APOTEXANDA 219227ABApr 02, 2026
NINTEDANIB ESYLATE×2CIPLAANDA 212609ABApr 02, 2026
NINTEDANIB ESYLATE×2DEXCELANDA 219819ABApr 02, 2026
NINTEDANIB ESYLATE×2DR REDDYSANDA 219283ABApr 02, 2026
NINTEDANIB ESYLATE×2SANDOZANDA 216915ABApr 02, 2026

Marketing exclusivity (4)

  • ODE-261Orphan-drug exclusivity (7 years)

    Sep 06, 2026

    in 3 mo

  • PEDPediatric exclusivity (adds 6 months)

    Mar 06, 2027

    in 9 mo

  • ODE-261Orphan-drug exclusivity (7 years)

    Sep 06, 2026

    in 3 mo

  • PEDPediatric exclusivity (adds 6 months)

    Mar 06, 2027

    in 9 mo

Listed patents (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
6762180Oct 01, 20259 mo ago
SubstanceProduct
10154990Jan 08, 20265 mo ago
U-2620
6762180*PEDApr 01, 20263 mo ago
10154990*PEDJul 08, 2026in 19 d
10105323Jun 04, 2029in 3 yr
Product
9907756Jun 07, 2029in 3 yr
Product
10105323*PEDDec 04, 2029in 3 yr 6 mo
9907756*PEDDec 07, 2029in 3 yr 6 mo

Nintedanib esylate — frequently asked questions

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

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