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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Express Scripts
Federal Trade Commission
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Boehringer Ingelheim
US Department of Justice
Citi
Harvard Business School
Julphar

Generated: October 23, 2017

DrugPatentWatch Database Preview

Adapalene - Generic Drug Details

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

Adapalene
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-three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Adapalene has fifty-seven patent family members in twenty-two countries and two supplementary protection certificates in two countries.

There are eleven drug master file entries for adapalene. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: adapalene

US Patents:23
Tradenames:5
Applicants:9
NDAs:16
Drug Master File Entries: see list11
Suppliers / Packagers: see list17
Bulk Api Vendors: see list98
Clinical Trials: see list57
Patent Applications: see list3,255
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:adapalene at DailyMed

Pharmacology for Ingredient: adapalene

Ingredient-typeRetinoids
Drug ClassRetinoid

Tentative approvals for ADAPALENE

Applicant Application No. Strength Dosage Form
u► Subscribe1%;2%GEL;TOPICAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Fougera Pharms
ADAPALENE
adapalene
CREAM;TOPICAL090824-001Jun 30, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Galderma Labs Lp
DIFFERIN
adapalene
LOTION;TOPICAL022502-001Mar 17, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: adapalene

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp
DIFFERIN
adapalene
SOLUTION;TOPICAL020338-001May 31, 1996► Subscribe► Subscribe
Galderma Labs Lp
DIFFERIN
adapalene
GEL;TOPICAL021753-001Jun 19, 2007► Subscribe► Subscribe
Galderma Labs Lp
DIFFERIN
adapalene
CREAM;TOPICAL020748-001May 26, 2000► Subscribe► Subscribe
Galderma Labs Lp
DIFFERIN
adapalene
GEL;TOPICAL021753-001Jun 19, 2007► Subscribe► Subscribe
Galderma Labs Lp
DIFFERIN
adapalene
SOLUTION;TOPICAL020338-001May 31, 1996► Subscribe► Subscribe
Galderma Labs Lp
DIFFERIN
adapalene
CREAM;TOPICAL020748-001May 26, 2000► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: adapalene

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
8,653,140Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► Subscribe
9,387,187Administration of 6[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► Subscribe
8,921,423Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid► Subscribe
9,622,994Method for the treatment of acne using pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid► Subscribe
8,729,127Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► Subscribe
9,381,179Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► 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: adapalene

Country Document Number Estimated Expiration
Poland372317► Subscribe
Spain2327508► Subscribe
Austria432072► Subscribe
Mexico2008003422► Subscribe
South Korea101358490► Subscribe
Portugal1485080► Subscribe
South Korea20040111394► Subscribe
Russian Federation2332208► Subscribe
Argentina057866► Subscribe
European Patent Office1532974► 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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Supplementary Protection Certificates for Tradename: ADAPALENE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB10/005United Kingdom► SubscribePRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
C0024France► SubscribePRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Citi
Argus Health
Express Scripts
US Army
Cerilliant
Harvard Business School
McKinsey
Baxter
Teva
Boehringer Ingelheim

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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