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Last Updated: August 10, 2020

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AZELAIC ACID Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Azelaic Acid

A generic version of AZELAIC ACID was approved as azelaic acid by ACTAVIS LABS UT INC on November 19th, 2018.

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Drug patent expirations by year for AZELAIC ACID
Drug Prices for AZELAIC ACID

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Recent Clinical Trials for AZELAIC ACID

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SponsorPhase
Clinical Research Center of the CarolinasPhase 4
Assiut UniversityPhase 4
Taro Pharmaceuticals USAPhase 1

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Pharmacology for AZELAIC ACID
Paragraph IV (Patent) Challenges for AZELAIC ACID
Tradename Dosage Ingredient NDA Submissiondate
FINACEA AEROSOL, FOAM;TOPICAL azelaic acid 207071 2017-09-14
FINACEA GEL;TOPICAL azelaic acid 021470 2012-07-27

US Patents and Regulatory Information for AZELAIC ACID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Ut Inc AZELAIC ACID azelaic acid GEL;TOPICAL 208011-001 Nov 19, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Tolmar AZELAIC ACID azelaic acid GEL;TOPICAL 208724-001 Nov 19, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Glenmark Pharms AZELAIC ACID azelaic acid GEL;TOPICAL 204637-001 Nov 19, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Taro AZELAIC ACID azelaic acid GEL;TOPICAL 210549-001 Aug 23, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Moodys
Merck
McKinsey
Boehringer Ingelheim
Mallinckrodt

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