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Serving leading biopharmaceutical companies globally:

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Generated: December 14, 2017

DrugPatentWatch Database Preview

Azelaic acid - Generic Drug Details

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What are the generic sources for azelaic acid and what is the scope of azelaic acid freedom to operate?

Azelaic acid
is the generic ingredient in two branded drugs marketed by Bayer Hlthcare and Allergan, and is included in three 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 ninety-six patent family members in thirty-one countries.

There are eight drug master file entries for azelaic acid. Five suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for azelaic acid

Tentative approvals for AZELAIC ACID

Applicant Application No. Strength Dosage Form
u► Subscribe15%GEL;TOPICAL
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► 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► 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
AllerganAZELEXazelaic acidCREAM;TOPICAL020428-001Sep 13, 1995RXYesYes► 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
Bayer HlthcareFINACEA azelaic acidAEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: azelaic acid

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
AllerganAZELEXazelaic acidCREAM;TOPICAL020428-001Sep 13, 1995► Subscribe► Subscribe
Bayer HlthcareFINACEAazelaic acidGEL;TOPICAL021470-001Dec 24, 2002► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: azelaic acid

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 Ingredient: azelaic acid

Country Document Number Estimated Expiration
Japan2008540508► Subscribe
Germany59802473► Subscribe
World Intellectual Property Organization (WIPO)2009098595► Subscribe
Israel173092► Subscribe
New Zealand540166► Subscribe
Australia2005204341► Subscribe
World Intellectual Property Organization (WIPO)2007054818► Subscribe
Spain2431330► Subscribe
Hungary0004375► Subscribe
World Intellectual Property Organization (WIPO)2009007785► 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:

Covington
Argus Health
Colorcon
Mallinckrodt
Johnson and Johnson
Harvard Business School
QuintilesIMS
Boehringer Ingelheim
Chinese Patent Office
Chubb

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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