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FDA Orange Book · active-ingredient family

Tipiracil hydrochloride; trifluridine

Tipiracil hydrochloride; trifluridine is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:LONSURF · NDA 207981

1

Brand (NDA)

2

Generics (ANDA)

6

Listed patents

2

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
LONSURFRLD×2TAIHO ONCOLOGYNDA 207981ABSep 22, 2015

Generic (ANDA) products (2)

ProductApplicantApplicationTEApproved
TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE×2MSNANDA 214024ABJan 08, 2025
TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE×2NATCOANDA 214008ABJun 13, 2023

Marketing exclusivity (2)

  • ODE-229Orphan-drug exclusivity (7 years)

    Feb 22, 2026

    4 mo ago

  • ODE-229Orphan-drug exclusivity (7 years)

    Feb 22, 2026

    4 mo ago

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
RE46284Sep 22, 2029in 3 yr 4 mo
U-2503
9527833Jun 17, 2034in 8 yr 1 mo
SubstanceProduct
10457666Jun 17, 2034in 8 yr 1 mo
SubstanceProduct
9943537Sep 05, 2034in 8 yr 4 mo
U-3659
10456399Feb 03, 2037in 10 yr 9 mo
U-3657
10960004Feb 03, 2037in 10 yr 9 mo
U-3657

Tipiracil hydrochloride; trifluridine — frequently asked questions

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

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