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Serving leading biopharmaceutical companies globally:

Merck
Argus Health
Medtronic
Queensland Health
McKinsey
Cerilliant
Harvard Business School
Cantor Fitzgerald
Teva
AstraZeneca

Generated: February 23, 2018

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-four patent family members in twenty-two countries.

There are twenty-five drug master file entries for apremilast. One supplier is listed for this compound.
Pharmacology for apremilast

US Patents and Regulatory Information 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;ORAL 205437-003 Mar 21, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
7,276,529 Methods of the treatment or prevention of exercise-induced asthma using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione ➤ Sign Up
7,659,303 Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4- acetylaminoisoindoline-1,3-dione ➤ Sign Up
9,724,330 Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione ➤ Sign Up
6,011,050 Substituted phenethylsulfones and method of reducing TNF.alpha. levels ➤ Sign Up
8,093,283 Solid forms comprising (+)-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisi- noline-1,3-dione, compositions thereof, and uses thereof ➤ Sign Up
9,283,207 Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione ➤ Sign Up
9,433,606 Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof ➤ Sign Up
8,629,173 Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof ➤ Sign Up
7,358,272 Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione ➤ Sign Up
7,507,759 Methods of using(+)-2-[1-(3-ethoxy-4methoxyphenyl)-2-methylsulfonylethyl]-- 4-acetylaminoisoindoline-1,3,-dione ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for apremilast

Country Document Number Estimated Expiration
Hong Kong 1103224 ➤ Sign Up
Cyprus 1119204 ➤ Sign Up
Slovenia 1485087 ➤ Sign Up
Australia 756308 ➤ Sign Up
Portugal 2295055 ➤ Sign Up
Spain 2637509 ➤ Sign Up
South Korea 100997001 ➤ Sign Up
Canada 2479666 ➤ Sign Up
Spain 2421153 ➤ Sign Up
Mexico PA04009075 ➤ Sign Up
Country Document Number Estimated Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Deloitte
Queensland Health
Dow
US Department of Justice
US Army
Healthtrust
Baxter
Argus Health

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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