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Last Updated: April 13, 2024

FINACEA Drug Patent 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 five 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. Eight suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.

DrugPatentWatch® 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Wake Forest University Health SciencesEarly Phase 1
Clinical Research Center of the CarolinasPhase 4
Perrigo CompanyPhase 3

See all FINACEA clinical trials

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

FINACEA is protected by five US patents.

Patents protecting FINACEA

Foamable composition combining a polar solvent and a hydrophobic carrier
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA

Penetrating pharmaceutical foam
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Penetrating pharmaceutical foam
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA

Antibiotic kit and composition and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA

Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 RX Yes Yes ⤷  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 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 ⤷  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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FINACEA

See the table below for patents covering FINACEA around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2007023396 ⤷  Try a Trial
Japan H0745401 ⤷  Try a Trial
South Korea 20050083826 COSMETIC AND PHARMACEUTICAL FOAM ⤷  Try a Trial
European Patent Office 2526930 Préparation vitaminée (Vitamin formulation) ⤷  Try a Trial
>Country >Patent Number >Title >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.