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Generated: April 27, 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 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 nine 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 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

Drug Master File Entries: see list8
Suppliers / Packagers: see list5
Bulk Api Vendors: see list71
Clinical Trials: see list2,072
Patent Applications: see list25,142
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
azelaic acid
CREAM;TOPICAL020428-001Sep 13, 1995RXYesYes► Subscribe► Subscribe
Bayer Hlthcare
azelaic acid
AEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes8,900,554► SubscribeY ► Subscribe
Bayer Hlthcare
azelaic acid
AEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes9,265,725► SubscribeY ► Subscribe
Bayer Hlthcare
azelaic acid
AEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes7,700,076► SubscribeY ► Subscribe
Bayer Hlthcare
azelaic acid
AEROSOL, FOAM;TOPICAL207071-001Jul 29, 2015RXYesYes► Subscribe► Subscribe
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