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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,455,536

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Which drugs does patent 8,455,536 protect, and when does it expire?


Patent 8,455,536 protects OTEZLA and is included in one NDA.

This patent has forty-nine patent family members in twenty countries.

Summary for Patent: 8,455,536

Title:Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline 1,3-dione
Abstract: Stereomerically pure (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, substantially free of its (-) isomer, and prodrugs, metabolites, polymorphs, salts, solvates, hydrates, and clathrates thereof are discussed. Also discussed are methods of using and pharmaceutical compositions comprising the (+) enantiomer of 2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoin- doline-1,3-dione are disclosed. The methods include methods of treating and/or preventing disorders ameliorated by the reduction of levels of TNF-.alpha. or the inhibition of PDE4.
Inventor(s): Muller; George W. (Rancho Santa Fe, CA), Schafer; Peter H. (Somerset, NJ), Man; Hon-Wah (Princeton, NJ), Ge; Chuansheng (Belle Mead, NJ)
Assignee: Celgene Corporation (Summit, NJ)
Application Number:12/630,788
Patent Claim Types:
see list of patent claims
Use; Dosage form; Delivery;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Patented / Exclusive Use
Celgene CorpOTEZLAapremilastTABLET;ORAL205437-001Mar 21, 2014RXYesNo► Subscribe► Subscribe► SubscribeUSE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
Celgene CorpOTEZLAapremilastTABLET;ORAL205437-001Mar 21, 2014RXYesNo► Subscribe► Subscribe► SubscribeUSE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
Celgene CorpOTEZLAapremilastTABLET;ORAL205437-002Mar 21, 2014RXYesNo► Subscribe► Subscribe► SubscribeUSE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
Celgene CorpOTEZLAapremilastTABLET;ORAL205437-002Mar 21, 2014RXYesNo► Subscribe► Subscribe► SubscribeUSE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
Celgene CorpOTEZLAapremilastTABLET;ORAL205437-003Mar 21, 2014RXYesYes► Subscribe► Subscribe► SubscribeUSE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
Celgene CorpOTEZLAapremilastTABLET;ORAL205437-003Mar 21, 2014RXYesYes► Subscribe► Subscribe► SubscribeUSE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
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Non-Orange Book Patents for Patent: 8,455,536

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
7,659,302Methods 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
8,802,717Methods of treating arthritic conditions using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline 1,3-dione► Subscribe
6,962,940 (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoiso indoline-1,3-dione: methods of using and compositions thereof► Subscribe
7,659,303Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4- acetylaminoisoindoline-1,3-dione► Subscribe
9,018,243Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof► Subscribe
7,893,101Solid 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
8,093,283Solid forms comprising (+)-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisi- noline-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 Patent: 8,455,536

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Slovenia1485087► Subscribe
Portugal2420490► Subscribe
Portugal2295055► Subscribe
Portugal2223687► Subscribe
Portugal1485087► Subscribe
New Zealand535798► Subscribe
South Korea100997001► Subscribe
South Korea20050012722► Subscribe
Japan2015013893► Subscribe
Spain2637547► 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:

Queensland Health
Fish and Richardson
Harvard Business School
Novartis
Dow
Merck
Julphar
UBS
Citi
Mallinckrodt

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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