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Last Updated: December 2, 2021

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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
Assiut UniversityPhase 4
Clinical Research Center of the CarolinasPhase 4
Padagis LLCPhase 3

See all azelaic acid clinical trials

Generic filers with tentative approvals for AZELAIC ACID
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial15%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 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
Glenmark Pharms AZELAIC ACID azelaic acid GEL;TOPICAL 204637-001 Nov 19, 2018 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Leo Pharma As FINACEA azelaic acid GEL;TOPICAL 021470-001 Dec 24, 2002 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Tolmar AZELAIC ACID azelaic acid GEL;TOPICAL 208724-001 Nov 19, 2018 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 GEL;TOPICAL 021470-001 Dec 24, 2002 ⤷  Free Forever Trial ⤷  Free Forever Trial
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 ⤷  Free Forever Trial ⤷  Free Forever Trial
Almirall AZELEX azelaic acid CREAM;TOPICAL 020428-001 Sep 13, 1995 ⤷  Free Forever Trial ⤷  Free Forever 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

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.