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, Encube, Glenmark Pharms, 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: | 6,494 |
Formulation / Manufacturing: | see details |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 | |||
Glenmark Pharms | AZELAIC ACID | azelaic acid | GEL;TOPICAL | 204637-001 | 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 | ⤷ Sign Up | ||||
Almirall | AZELEX | azelaic acid | CREAM;TOPICAL | 020428-001 | Sep 13, 1995 | RX | Yes | Yes | ⤷ 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 |
---|---|---|---|---|---|---|---|
Almirall | AZELEX | azelaic acid | CREAM;TOPICAL | 020428-001 | Sep 13, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Leo Pharma As | FINACEA | azelaic acid | GEL;TOPICAL | 021470-001 | Dec 24, 2002 | ⤷ 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 | 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 |
Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | ⤷ 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 |
---|---|---|---|
Japan | 2007503428 | ⤷ Sign Up | |
Denmark | 2494959 | ⤷ Sign Up | |
Poland | 2494959 | ⤷ Sign Up | |
South Africa | 200710619 | Foamable vehicle and pharmaceutical compositions thereof | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2007007198 | ⤷ Sign Up | |
European Patent Office | 2097065 | COMPOSITIONS COMPORTANT DES AGENTS DE MODULATION (FOAMABLE WATERLESS COMPOSITIONS WITH MODULATING AGENTS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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