AZELAIC ACID Drug Patent Profile
✉ Email this page to a colleague
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 Pharms, 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. Eight 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.
Summary for AZELAIC ACID
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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
