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Generated: April 26, 2017

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Adapalene - Generic Drug Details

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

is the generic ingredient in five branded drugs marketed by Actavis Mid Atlantic, Galderma Labs Lp, Glenmark Generics, Taro, Fougera Pharms, Pliva Hrvatska Doo, Call Inc, Tolmar, and Galderma Labs, and is included in sixteen NDAs. There are twenty-four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Adapalene has forty-nine patent family members in twenty-two countries.

There are eleven drug master file entries for adapalene. Eighteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: adapalene

Drug Master File Entries: see list11
Suppliers / Packagers: see list18
Bulk Api Vendors: see list96
Clinical Trials: see list31
Patent Applications: see list3,121
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:adapalene at DailyMed

Pharmacology for Ingredient: adapalene

Drug ClassRetinoid

Tentative approvals for ADAPALENE

Applicant Application No. Form Dosage
► Subscribe► SubscribeGEL;TOPICAL0.1%;2.5%
► Subscribe► SubscribeGEL;TOPICAL1%;2%
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYesYes8,785,420► Subscribe ► Subscribe
Call Inc
SOLUTION;TOPICAL203981-001Sep 23, 2016ABRXNoNo► Subscribe► Subscribe
Galderma Labs Lp
GEL;TOPICAL021753-001Jun 19, 2007ABRXYesYes8,703,820► Subscribe ► Subscribe
Galderma Labs Lp
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes8,241,649► SubscribeY ► Subscribe
Glenmark Generics
GEL;TOPICAL091314-001Jul 1, 2010ABRXNoNo► Subscribe► Subscribe
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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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