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
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 148 |
| Patent Applications: | 3,862 |
| 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 |
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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Australia | 524602 | ⤷ Sign Up | |
| Japan | S53130433 | COMPOSITION AND METHOD FOR TREATING HYPERCHROMOCYTE SKIN DISEASE | ⤷ Sign Up |
| Switzerland | 638099 | Composition for the treatment of dermatoses characterised by hyperpigmentation | ⤷ Sign Up |
| Germany | 2817133 | ⤷ Sign Up | |
| Australia | 3502778 | ⤷ Sign Up | |
| South Africa | 7802125 | ⤷ 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.
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