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FDA Orange Book · active-ingredient family

Azelaic acid

Azelaic acid is approved as 3 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FINACEA · NDA 207071

3

Brand (NDA)

5

Generics (ANDA)

4

Listed patents

0

Exclusivity periods

Brand (NDA) products · aerosol, foam, cream, gel

ProductApplicantApplicationTEApproved
FINACEARLDLEO PHARMA ASNDA 207071—Jul 29, 2015
FINACEARLDLEO PHARMA ASNDA 021470ABDec 24, 2002
AZELEXRLDALMIRALLNDA 020428—Sep 13, 1995

Generic (ANDA) products (5)

ProductApplicantApplicationTEApproved
AZELAIC ACIDAUROBINDO PHARMA USAANDA 210928—Oct 07, 2020
AZELAIC ACIDSUN PHARMA CANADAANDA 210549ABAug 23, 2019
AZELAIC ACIDACTAVIS LABS UT INCANDA 208011ABNov 19, 2018
AZELAIC ACIDENCUBEANDA 208724ABNov 19, 2018
AZELAIC ACIDGLENMARK SPECLTANDA 204637ABNov 19, 2018

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7700076Sep 18, 2027in 1 yr 3 mo
Product
10117812Oct 18, 2027in 1 yr 4 mo
ProductU-1796
9265725Dec 08, 2027in 1 yr 6 mo
Product
9211259Feb 28, 2029in 2 yr 9 mo
U-1796

Azelaic acid — 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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