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Serving leading biopharmaceutical companies globally:

Accenture
Medtronic
Chinese Patent Office
Farmers Insurance
Merck
Deloitte
Healthtrust
McKinsey
QuintilesIMS
Federal Trade Commission

Generated: December 15, 2017

DrugPatentWatch Database Preview

FINACEA Drug Profile

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When do Finacea patents expire, and what generic alternatives are available?

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

This drug has one hundred and ninety-six patent family members in thirty-one countries.

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

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Bayer HlthcareFINACEA azelaic acidAEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Bayer HlthcareFINACEA azelaic acidAEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Bayer HlthcareFINACEA azelaic acidAEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Bayer HlthcareFINACEA azelaic acidAEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Bayer HlthcareFINACEA azelaic acidAEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Bayer HlthcareFINACEA azelaic acidAEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Bayer HlthcareFINACEA azelaic acidAEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Bayer HlthcareFINACEA azelaic acidAEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Bayer HlthcareFINACEAazelaic acidGEL;TOPICAL021470-001Dec 24, 2002RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for FINACEA

Drugname Dosage Strength RLD Submissiondate
azelaic acidTopical Foam15%Finacea9/14/2017
azelaic acidGel15%Finacea7/27/2012

Non-Orange Book Patents for Tradename: FINACEA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,795,693Compositions with modulating agents► Subscribe
8,741,265Penetrating pharmaceutical foam► Subscribe
7,704,518Foamable vehicle and pharmaceutical compositions thereof► Subscribe
9,050,253Oleaginous pharmaceutical and cosmetic foam► Subscribe
8,518,378Oleaginous pharmaceutical and cosmetic foam► Subscribe
8,362,091Foamable vehicle and pharmaceutical compositions thereof► Subscribe
7,029,659Mousse composition► Subscribe
9,320,705Sensation modifying topical composition foam► Subscribe
9,539,208Foam prepared from nanoemulsions and uses► Subscribe
7,820,145Oleaginous pharmaceutical and cosmetic foam► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: FINACEA

Country Document Number Estimated Expiration
Canada2610662► Subscribe
Canada2565754► Subscribe
South Africa200706383► Subscribe
Canada2549505► Subscribe
World Intellectual Property Organization (WIPO)2008038147► Subscribe
Denmark1032379► Subscribe
Japan2007508243► Subscribe
South Africa200502171► Subscribe
World Intellectual Property Organization (WIPO)2009098595► Subscribe
Japan2008542353► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

UBS
Cerilliant
Covington
Daiichi Sankyo
QuintilesIMS
Moodys
Novartis
Queensland Health
Farmers Insurance
Express Scripts

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 verifification 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.

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