AZELAIC ACID - Generic Drug Details
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What are the generic drug sources for azelaic acid and what is the scope of freedom to operate?
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. Eight 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: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 148 |
Clinical Trials: | 35 |
Patent Applications: | 7,349 |
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 |
---|---|
South Valley University | N/A |
Combined Military Hospital Abbottabad | Phase 1 |
Wake Forest University Health Sciences | Early Phase 1 |
Generic filers with tentative approvals for AZELAIC ACID
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 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 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glenmark Pharms | AZELAIC ACID | azelaic acid | GEL;TOPICAL | 204637-001 | Nov 19, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Actavis Labs Ut Inc | AZELAIC ACID | azelaic acid | GEL;TOPICAL | 208011-001 | Nov 19, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Encube | AZELAIC ACID | azelaic acid | GEL;TOPICAL | 208724-001 | Nov 19, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Taro | AZELAIC ACID | azelaic acid | GEL;TOPICAL | 210549-001 | Aug 23, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Teva Pharms Usa | AZELAIC ACID | azelaic acid | AEROSOL, FOAM;TOPICAL | 210928-001 | Oct 7, 2020 | DISCN | No | No | ⤷ 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 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 | ⤷ Try a Trial | ⤷ Try a Trial |
Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Leo Pharma As | FINACEA | azelaic acid | GEL;TOPICAL | 021470-001 | Dec 24, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
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 AZELAIC ACID
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2004037225 | ⤷ Try a Trial | |
Japan | 2007503428 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2005018530 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2006003481 | ⤷ Try a Trial | |
Mexico | PA06006923 | ESPUMA OLEAGINOSA FARMACEUTICA Y COSMETICA. (OLEAGINOUS PHARMACEUTICAL AND COSMETIC FOAM.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
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