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Last Updated: July 16, 2020

DrugPatentWatch Database Preview

Azelaic acid - Generic Drug Details

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What are the generic sources for azelaic acid and what is the scope of patent protection?

Azelaic acid is the generic ingredient in three branded drugs marketed by Leo Pharma As, Almirall, Actavis Labs Ut Inc, Glenmark Pharms, Taro, and Tolmar, and is included in seven NDAs. There are eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Azelaic acid has one hundred and thirty-seven patent family members in twenty countries.

There are eight drug master file entries for azelaic acid. Ten suppliers are listed for this compound.

Drug Prices for azelaic acid

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Recent Clinical Trials for azelaic acid

Identify potential brand extensions & 505(b)(2) entrants

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

See all azelaic acid clinical trials

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
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 RX Yes Yes   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
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for azelaic acid

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015   Start Trial   Start Trial
Leo Pharma As FINACEA azelaic acid GEL;TOPICAL 021470-001 Dec 24, 2002   Start Trial   Start Trial
Leo Pharma As FINACEA azelaic acid GEL;TOPICAL 021470-001 Dec 24, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Merck
Dow
AstraZeneca
McKinsey
McKesson

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