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Last Updated: November 22, 2024

AZELEX Drug Patent Profile


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When do Azelex patents expire, and when can generic versions of Azelex launch?

Azelex is a drug marketed by Almirall and is included in one NDA.

The generic ingredient in AZELEX is azelaic acid. There are eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Azelex

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

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Summary for AZELEX
Drug patent expirations by year for AZELEX
Drug Prices for AZELEX

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Pharmacology for AZELEX

US Patents and Regulatory Information for AZELEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Almirall AZELEX azelaic acid CREAM;TOPICAL 020428-001 Sep 13, 1995 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for AZELEX

See the table below for patents covering AZELEX around the world.

Country Patent Number Title Estimated Expiration
Japan S53130433 COMPOSITION AND METHOD FOR TREATING HYPERCHROMOCYTE SKIN DISEASE ⤷  Sign Up
Canada 1137873 COMPOSE POUR LE TRAITEMENT DES DERMATOSES PROVOQUANT UNE HYPERPIGMENTATION ET AUTRES AFFECTIONS DU GENRE (COMPOSITION OF TREATMENT OF HYPERPIGMENTARY DERMATOSES AND THE LIKE) ⤷  Sign Up
South Africa 7802125 ⤷  Sign Up
Italy 1075741 COMPOSIZIONE PER IL TRATTAMENTO DI DERMATOSI IPERPIGMENTARIE ⤷  Sign Up
Germany 2817133 ⤷  Sign Up
Australia 524602 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.