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Serving leading biopharmaceutical companies globally:

Argus Health
Chinese Patent Office
QuintilesIMS
Cantor Fitzgerald
Cipla
McKinsey
US Department of Justice
Fuji
US Army
Cerilliant

Generated: October 20, 2017

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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 azelaic acid freedom to operate?

Azelaic acid
is the generic ingredient in two branded drugs marketed by Allergan and Bayer Hlthcare, and is included in three NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. 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.

Summary for Generic Name: azelaic acid

US Patents:8
Tradenames:2
Applicants:2
NDAs:3
Drug Master File Entries: see list8
Suppliers / Packagers: see list5
Bulk Api Vendors: see list71
Clinical Trials: see list4,923
Patent Applications: see list9,844
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:azelaic acid at DailyMed

Pharmacology for Ingredient: 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 Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
FINACEA
azelaic acid
AEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Bayer Hlthcare
FINACEA
azelaic acid
AEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Allergan
AZELEX
azelaic acid
CREAM;TOPICAL020428-001Sep 13, 1995RXYesYes► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
FINACEA
azelaic acid
AEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Bayer Hlthcare
FINACEA
azelaic acid
AEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Bayer Hlthcare
FINACEA
azelaic acid
AEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Bayer Hlthcare
FINACEA
azelaic acid
AEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Bayer Hlthcare
FINACEA
azelaic acid
AEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Bayer Hlthcare
FINACEA
azelaic acid
GEL;TOPICAL021470-001Dec 24, 2002RXYesYes► Subscribe► Subscribe ► Subscribe
Bayer Hlthcare
FINACEA
azelaic acid
AEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes► 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
Allergan
AZELEX
azelaic acid
CREAM;TOPICAL020428-001Sep 13, 1995► Subscribe► Subscribe
Bayer Hlthcare
FINACEA
azelaic acid
GEL;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
8,629,128Vitamin formulation► Subscribe
8,114,385Oleaginous pharmaceutical and cosmetic foam► Subscribe
9,050,253Oleaginous pharmaceutical and cosmetic foam► Subscribe
8,795,693Compositions with modulating agents► Subscribe
8,741,265Penetrating pharmaceutical foam► Subscribe
9,320,705Sensation modifying topical composition foam► Subscribe
2,010,040,561► Subscribe
8,362,091Foamable vehicle and pharmaceutical compositions thereof► Subscribe
9,636,405Foamable vehicle and pharmaceutical compositions thereof► Subscribe
9,492,412Penetrating pharmaceutical 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
Canada2610662► Subscribe
BrazilPI0612429► Subscribe
South Africa200502180► Subscribe
World Intellectual Property Organization (WIPO)2005011567► Subscribe
Israel198687► Subscribe
World Intellectual Property Organization (WIPO)2005018530► Subscribe
Australia2007355106► Subscribe
MexicoPA06006923► Subscribe
Australia2009211147► Subscribe
World Intellectual Property Organization (WIPO)2007099396► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Cipla
Accenture
Mallinckrodt
Chinese Patent Office
Cantor Fitzgerald
Baxter
Cerilliant
Argus Health
Farmers Insurance
Healthtrust

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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