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Last Updated: July 5, 2020

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FINACEA Drug Profile


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When do Finacea patents expire, and when can generic versions of Finacea launch?

Finacea is a drug marketed by Leo Pharma As and is included in two NDAs. There are eight patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-seven patent family members in twenty countries.

The generic ingredient in FINACEA is azelaic acid. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.

US ANDA Litigation and Generic Entry Outlook for Finacea

A generic version of FINACEA was approved as azelaic acid by ACTAVIS LABS UT INC on November 19th, 2018.

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Drug patent expirations by year for FINACEA
Drug Prices for FINACEA

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Drug Sales Revenue Trends for FINACEA

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Recent Clinical Trials for FINACEA

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SponsorPhase
Clinical Research Center of the CarolinasPhase 4
Taro Pharmaceuticals USAPhase 1
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering PharmaPhase 4

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Pharmacology for FINACEA
Paragraph IV (Patent) Challenges for FINACEA
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 FINACEA

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   Start Trial   Start Trial Y   Start Trial
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 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 FINACEA

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   Start Trial   Start Trial
Leo Pharma As FINACEA azelaic acid GEL;TOPICAL 021470-001 Dec 24, 2002   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 FINACEA

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Serving leading biopharmaceutical companies globally:

Merck
McKinsey
Harvard Business School
Baxter
Johnson and Johnson
Boehringer Ingelheim

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