Assyro AI

FDA Orange Book · active-ingredient family

Trifarotene

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

Reference-listed drug:AKLIEF · NDA 211527

1

Brand (NDA)

0

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · cream

ProductApplicantApplicationTEApproved
AKLIEFRLDGALDERMA LABS LPNDA 211527Oct 04, 2019

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7807708Jul 19, 2031in 5 yr 2 mo
SubstanceProduct
9084778May 30, 2033in 7 yr 1 mo
ProductU-134
9498465May 30, 2033in 7 yr 1 mo
ProductU-1033

Trifarotene — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.