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Last Updated: October 6, 2022

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 Teva Pharms Usa, Leo Pharma As, Almirall, Actavis Labs Ut Inc, Glenmark Pharms, Taro, and Tolmar, and is included in eight 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. Eight suppliers are listed for this compound. There is one tentative approval 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
Wake Forest University Health SciencesEarly Phase 1
Assiut UniversityPhase 4
Clinical Research Center of the CarolinasPhase 4

See all azelaic acid clinical trials

Generic filers with tentative approvals for AZELAIC ACID
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing15%AEROSOL, FOAM;TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for azelaic acid
Paragraph IV (Patent) Challenges for AZELAIC ACID
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FINACEA Topical Foam azelaic acid 15% 207071 1 2017-09-14
FINACEA Gel azelaic acid 15% 021470 1 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 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Taro AZELAIC ACID azelaic acid GEL;TOPICAL 210549-001 Aug 23, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Almirall AZELEX azelaic acid CREAM;TOPICAL 020428-001 Sep 13, 1995 See Plans and Pricing See Plans and Pricing
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 See Plans and Pricing See Plans and Pricing
Leo Pharma As FINACEA azelaic acid GEL;TOPICAL 021470-001 Dec 24, 2002 See Plans and Pricing See Plans and Pricing
Leo Pharma As FINACEA azelaic acid GEL;TOPICAL 021470-001 Dec 24, 2002 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for azelaic acid

Country Patent Number Title Estimated Expiration
European Patent Office 1556009 MOUSSE COSMETIQUE ET PHARMACEUTIQUE (COSMETIC AND PHARMACEUTICAL FOAM) See Plans and Pricing
Japan 2007508243 See Plans and Pricing
Australia 2007355106 Foamable waterless compositions with modulating agents See Plans and Pricing
Australia 2007356328 Stable non-alcoholic foamable pharmaceutical emulsion compositions with an unctuous emollient and their uses See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Dow
Boehringer Ingelheim
Harvard Business School
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.