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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, Glenmark Pharms, Taro, and Tolmar, and is included in eight NDAs. There are eight 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.
Summary for azelaic acid
| International Patents: | 137 |
| US Patents: | 8 |
| Tradenames: | 3 |
| Applicants: | 7 |
| NDAs: | 8 |
| Drug Master File Entries: | 8 |
| Suppliers / Packagers: | 8 |
| Bulk Api Vendors: | 118 |
| Clinical Trials: | 29 |
| Patent Applications: | 5,896 |
| 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 |
| DailyMed Link: | azelaic acid at DailyMed |
Recent Clinical Trials for azelaic acid
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Clinical Research Center of the Carolinas | Phase 4 |
| Assiut University | Phase 4 |
| Taro Pharmaceuticals USA | Phase 1 |
Pharmacology for azelaic acid
| Physiological Effect | Decreased Protein Synthesis Decreased Sebaceous Gland Activity |
Paragraph IV (Patent) Challenges for AZELAIC ACID
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FINACEA | AEROSOL, FOAM;TOPICAL | azelaic acid | 207071 | 2017-09-14 |
| FINACEA | GEL;TOPICAL | azelaic acid | 021470 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Taro | AZELAIC ACID | azelaic acid | GEL;TOPICAL | 210549-001 | Aug 23, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Tolmar | AZELAIC ACID | azelaic acid | GEL;TOPICAL | 208724-001 | Nov 19, 2018 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 | GEL;TOPICAL | 021470-001 | Dec 24, 2002 | Start Trial | Start Trial |
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | Start Trial | Start Trial |
| Leo Pharma As | FINACEA | azelaic acid | GEL;TOPICAL | 021470-001 | Dec 24, 2002 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for azelaic acid
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20050083826 | Start Trial |
| European Patent Office | 2051697 | Start Trial |
| Israel | 187276 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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.
ISSN: 2162-2639
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