Azelaic acid - Generic Drug Details
✉ Email this page to a colleague
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, Encube, Glenmark Speclt, and Taro, and is included in eight NDAs. There are five 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. Nine suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for azelaic acid
International Patents: | 137 |
US Patents: | 5 |
Tradenames: | 3 |
Applicants: | 7 |
NDAs: | 8 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 148 |
Clinical Trials: | 37 |
Patent Applications: | 6,553 |
Drug Prices: | Drug price trends for azelaic acid |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for azelaic acid |
What excipients (inactive ingredients) are in azelaic acid? | azelaic acid excipients list |
DailyMed Link: | azelaic acid at DailyMed |
Recent Clinical Trials for azelaic acid
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Insel Gruppe AG, University Hospital Bern | Phase 2 |
Chang Gung Memorial Hospital | Phase 1/Phase 2 |
South Valley University | N/A |
Generic filers with tentative approvals for AZELAIC ACID
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 15% | 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
Physiological Effect | Decreased Protein Synthesis Decreased Sebaceous Gland Activity |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Encube | AZELAIC ACID | azelaic acid | GEL;TOPICAL | 208724-001 | Nov 19, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Taro | AZELAIC ACID | azelaic acid | GEL;TOPICAL | 210549-001 | Aug 23, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Actavis Labs Ut Inc | AZELAIC ACID | azelaic acid | GEL;TOPICAL | 208011-001 | Nov 19, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 azelaic acid
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Almirall | AZELEX | azelaic acid | CREAM;TOPICAL | 020428-001 | Sep 13, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Leo Pharma As | FINACEA | azelaic acid | GEL;TOPICAL | 021470-001 | Dec 24, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for azelaic acid
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Africa | 200711243 | Vasoactive kit and composition and uses thereof | ⤷ Sign Up |
South Korea | 20060113657 | PENETRATING PHARMACEUTICAL FOAM | ⤷ Sign Up |
European Patent Office | 2422768 | Mousse pharmaceutique pénétrante (Penetrating pharmaceutical foam) | ⤷ Sign Up |
Mexico | PA06006923 | ESPUMA OLEAGINOSA FARMACEUTICA Y COSMETICA. (OLEAGINOUS PHARMACEUTICAL AND COSMETIC FOAM.) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.