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Serving leading biopharmaceutical companies globally:

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Generated: December 18, 2017

DrugPatentWatch Database Preview

OTEZLA Drug Profile

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When do Otezla patents expire, and what generic alternatives are available?

Otezla is a drug marketed by Celgene Corp and is included in one NDA. There are nine patents protecting this drug.

This drug has ninety-two patent family members in twenty-two countries.

The generic ingredient in OTEZLA is apremilast. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the apremilast profile page.

US Patents and Regulatory Information

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

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
9,724,330Methods of 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
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
6,011,050 Substituted phenethylsulfones and method of reducing TNF.alpha. levels► 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
8,093,283Solid forms comprising (+)-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisi- noline-1,3-dione, compositions thereof, and uses thereof► Subscribe
7,507,759Methods 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
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
9,283,207Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-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 Tradename: OTEZLA

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)0025777► Subscribe
Norway319790► Subscribe
Denmark2305248► Subscribe
South Korea20130100219► Subscribe
European Patent Office2420490► Subscribe
Hong Kong1038696► Subscribe
HungaryE029682► Subscribe
South Korea100997001► Subscribe
South Korea20100040938► Subscribe
Cyprus1107499► 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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Serving leading biopharmaceutical companies globally:

US Department of Justice
Accenture
Boehringer Ingelheim
Queensland Health
Chubb
US Army
AstraZeneca
UBS
Cipla
Fish and Richardson

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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