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Azelaic acid - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for azelaic acid?

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.

This ingredient has one hundred and eighty-seven patent family members in thirty 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

Tradenames:2
Patents:9
Applicants:2
NDAs:3
Drug Master File Entries: see list8
Suppliers / Packagers: see list5
Bulk Api Vendors: see list71
Clinical Trials: see list2,072
Patent Applications: see list16,857
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. Form Dosage
► Subscribe► SubscribeGEL;TOPICAL15%
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
FINACEA
azelaic acid
AEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes8,435,498► Subscribe ► Subscribe
Bayer Hlthcare
FINACEA
azelaic acid
AEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes9,211,259► Subscribe ► Subscribe
Allergan
AZELEX
azelaic acid
CREAM;TOPICAL020428-001Sep 13, 1995RXYesYes► Subscribe► Subscribe
Bayer Hlthcare
FINACEA
azelaic acid
AEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes7,700,076► SubscribeY ► Subscribe
Bayer Hlthcare
FINACEA
azelaic acid
AEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes9,265,725► 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, 19954,386,104► Subscribe
Bayer Hlthcare
FINACEA
azelaic acid
GEL;TOPICAL021470-001Dec 24, 20024,713,394► 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
9,539,208Foam prepared from nanoemulsions and uses► Subscribe
8,629,128Vitamin formulation► Subscribe
7,704,518Foamable vehicle and pharmaceutical compositions thereof► 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
Hungary226592► Subscribe
Turkey200001393► Subscribe
BrazilPI0612429► Subscribe
New Zealand540166► Subscribe
Australia2003279493► 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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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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