AZELAIC ACID Drug Patent Profile
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Which patents cover Azelaic Acid, and what generic alternatives are available?
Azelaic Acid is a drug marketed by Teva Pharms Usa, Actavis Labs Ut Inc, Encube, Glenmark Speclt, and Taro. and is included in five NDAs.
The generic ingredient in AZELAIC ACID 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 Azelaic Acid
A generic version of AZELAIC ACID was approved as azelaic acid by ACTAVIS LABS UT INC on November 19th, 2018.
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Summary for AZELAIC ACID
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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms Usa | AZELAIC ACID | azelaic acid | AEROSOL, FOAM;TOPICAL | 210928-001 | Oct 7, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glenmark Speclt | AZELAIC ACID | azelaic acid | GEL;TOPICAL | 204637-001 | Nov 19, 2018 | 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 | |||
| 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
