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FDA Orange Book · active-ingredient family

Tapinarof

Tapinarof is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:VTAMA · NDA 215272

1

Brand (NDA)

0

Generics (ANDA)

12

Listed patents

2

Exclusivity periods

Brand (NDA) products · cream

ProductApplicantApplicationTEApproved
VTAMARLDORGANON LLCNDA 215272—May 23, 2022

Marketing exclusivity (2)

  • I-956New indication exclusivity (3 years)

    Dec 12, 2027

    in 1 yr 6 mo

  • NCENew chemical entity exclusivity (5 years)

    May 23, 2027

    in 11 mo

Listed patents (12)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10426743May 19, 2036in 10 yr 1 mo
U-4048
11612573May 19, 2036in 10 yr 1 mo
U-4048
11617724May 19, 2036in 10 yr 1 mo
Product
11622945May 19, 2036in 10 yr 1 mo
Product
11458108May 19, 2036in 10 yr 1 mo
Product
10195160May 23, 2036in 10 yr 1 mo
Product
10647649Nov 13, 2038in 12 yr 7 mo
Substance
11597692Nov 13, 2038in 12 yr 7 mo
SubstanceProduct
11590088Nov 13, 2039in 13 yr 7 mo
U-2625
11497718Nov 13, 2039in 13 yr 7 mo
U-4048
11938099Nov 13, 2039in 13 yr 7 mo
U-4048
12569453Dec 18, 2039in 13 yr 8 mo
U-4048

Tapinarof — 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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