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. Eight 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.
Summary for AZELEX
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 148 |
Patent Applications: | 5,300 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for AZELEX |
What excipients (inactive ingredients) are in AZELEX? | AZELEX excipients list |
DailyMed Link: | AZELEX at DailyMed |
Pharmacology for AZELEX
Physiological Effect | Decreased Protein Synthesis Decreased Sebaceous Gland Activity |
Anatomical Therapeutic Chemical (ATC) Classes 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 AZELEX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Almirall | AZELEX | azelaic acid | CREAM;TOPICAL | 020428-001 | Sep 13, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AZELEX
See the table below for patents covering AZELEX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 2817133 | ⤷ Try a Trial | |
Belgium | 866151 | ⤷ Try a Trial | |
Australia | 524602 | ⤷ Try a Trial | |
Switzerland | 638099 | Composition for the treatment of dermatoses characterised by hyperpigmentation | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |