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Serving 500+ biopharmaceutical companies globally:

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Generated: September 23, 2017

DrugPatentWatch Database Preview

Apremilast - Generic Drug Details

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What are the generic sources for apremilast and what is the scope of apremilast patent protection?

Apremilast
is the generic ingredient in one branded drug marketed by Celgene Corp and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Apremilast has seventy-three patent family members in twenty-two countries.

There are eleven drug master file entries for apremilast. One supplier is listed for this compound.

Summary for Generic Name: apremilast

Tradenames:1
Patents:9
Applicants:1
NDAs:1
Drug Master File Entries: see list11
Suppliers / Packagers: see list1
Bulk Api Vendors: see list36
Clinical Trials: see list63
Patent Applications: see list113
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:apremilast at DailyMed

Pharmacology for Ingredient: apremilast

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-002Mar 21, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-001Mar 21, 2014RXYesNo► Subscribe► SubscribeYY ► Subscribe
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-003Mar 21, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-003Mar 21, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-002Mar 21, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-002Mar 21, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-003Mar 21, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-003Mar 21, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-001Mar 21, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-001Mar 21, 2014RXYesNo► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: apremilast

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
7,276,529Methods of the treatment or prevention of exercise-induced asthma using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione► Subscribe
8,093,283Solid forms comprising (+)-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisi- noline-1,3-dione, compositions thereof, and uses thereof► Subscribe
7,659,303Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4- acetylaminoisoindoline-1,3-dione► Subscribe
6,011,050 Substituted phenethylsulfones and method of reducing TNF.alpha. levels► Subscribe
7,507,759Methods of using(+)-2-[1-(3-ethoxy-4methoxyphenyl)-2-methylsulfonylethyl]-- 4-acetylaminoisoindoline-1,3,-dione► Subscribe
9,433,606Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof► Subscribe
9,724,330Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione► Subscribe
7,358,272Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione► Subscribe
9,283,207Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione► Subscribe
8,629,173Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof► 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: apremilast

Country Document Number Estimated Expiration
Japan5936521► Subscribe
European Patent Office2223688► Subscribe
Portugal1485087► Subscribe
Austria471718► Subscribe
Hong Kong1038696► Subscribe
Japan2015013893► Subscribe
Portugal1752148► Subscribe
SloveniaEP1485087► Subscribe
European Patent Office2305248► Subscribe
Denmark2420490► 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 500+ biopharmaceutical companies globally:

Baxter
Fuji
Teva
Argus Health
Novartis
Fish and Richardson
Chinese Patent Office
QuintilesIMS
Moodys
Harvard Business School

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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