FDA Orange Book · active-ingredient family
Azelaic acid
Azelaic acid: 3 brands, 5 generics; first approved Sep 13, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 5 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
5
Listed patents
4
Next patent expiry
Sep 18, 2027
in 1 yr 1 mo
Brand (NDA) products
Originator applications
- LEO PHARMA ASNDA 2070712015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15% AEROSOL, FOAM TOPICAL Rx — - LEO PHARMA ASNDA 0214702002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15% GEL TOPICAL Rx AB - ALMIRALLNDA 0204281995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20% CREAM TOPICAL Rx —
Generic (ANDA) products (5)
Abbreviated applications
- AZELAIC ACIDAUROBINDO PHARMA USAANDA 2109282020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15% AEROSOL, FOAM TOPICAL Discontinued — - AZELAIC ACIDSUN PHARMA CANADAANDA 2105492019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15% GEL TOPICAL Rx AB - AZELAIC ACIDACTAVIS LABS UT INCANDA 2080112018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15% GEL TOPICAL Rx AB - AZELAIC ACIDENCUBEANDA 2087242018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15% GEL TOPICAL Rx AB - AZELAIC ACIDGLENMARK SPECLTANDA 2046372018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15% GEL TOPICAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7700076 | in 1 yr 1 mo | Product | |
| 10117812 | in 1 yr 2 mo | ProductU-1796 | |
| 9265725 | in 1 yr 4 mo | Product | |
| 9211259 | in 2 yr 7 mo | U-1796 |
Approval history
FDA approval span
First approval
31 yr 4 mo ago
Most recent approval
5 yr 11 mo ago
Approvals span 1995–2020 across 8 FDA applications.
Brand (NDA) 338%
Generic (ANDA) 563%
Azelaic acid: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
