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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Baxter
Cantor Fitzgerald
Cipla
Express Scripts
Chubb
Citi
Cerilliant
Fuji
Johnson and Johnson

Generated: November 24, 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 ninety-three patent family members in twenty-two countries.

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

Pharmacology for 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;ORAL205437-003Mar 21, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-003Mar 21, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-001Mar 21, 2014RXYesNo► 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► SubscribeYY ► Subscribe
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-003Mar 21, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-001Mar 21, 2014RXYesNo► Subscribe► Subscribe► Subscribe
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-001Mar 21, 2014RXYesNo► Subscribe► SubscribeYY ► Subscribe
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-002Mar 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
7,659,303Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4- acetylaminoisoindoline-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
6,011,050 Substituted phenethylsulfones and method of reducing TNF.alpha. levels► 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
9,283,207Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione► Subscribe
9,724,330Methods 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
7,507,759Methods of using(+)-2-[1-(3-ethoxy-4methoxyphenyl)-2-methylsulfonylethyl]-- 4-acetylaminoisoindoline-1,3,-dione► Subscribe
7,358,272Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione► 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
World Intellectual Property Organization (WIPO)03080049► Subscribe
China1965823► Subscribe
Japan2005525386► Subscribe
Hong Kong1103985► Subscribe
Spain2343744► Subscribe
Spain2637547► Subscribe
Hong Kong1219049► Subscribe
South Korea20110022736► Subscribe
World Intellectual Property Organization (WIPO)0025777► Subscribe
Spain2608495► 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 leading biopharmaceutical companies globally:

QuintilesIMS
Fuji
Novartis
Express Scripts
Cantor Fitzgerald
Farmers Insurance
Argus Health
Fish and Richardson
Johnson and Johnson
Moodys

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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