Assyro AI

FDA Orange Book · active-ingredient family

Fenofibric acid

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

Reference-listed drug:FIBRICOR · NDA 022418

1

Brand (NDA)

0

Generics (ANDA)

4

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
FIBRICORRLD×2ROSEMONTNDA 022418Aug 14, 2009

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7569612Aug 20, 2027in 1 yr 2 mo
U-1000
7741374Aug 20, 2027in 1 yr 2 mo
U-1061
7741373Aug 20, 2027in 1 yr 2 mo
U-1059
7915247Aug 20, 2027in 1 yr 2 mo
U-1061

Fenofibric acid — 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.