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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Novartis
Merck
QuintilesIMS
Johnson and Johnson
UBS
McKinsey
Boehringer Ingelheim
Queensland Health
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Generated: June 22, 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-five patent family members in nineteen 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 Product Substance Delist Req. Patented / Exclusive Use
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-001Mar 21, 2014RXYesNo8,455,536► Subscribe USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-001Mar 21, 2014RXYesNo8,455,536► Subscribe USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-002Mar 21, 2014RXYesNo8,455,536► Subscribe USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-002Mar 21, 2014RXYesNo8,455,536► Subscribe USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
Celgene Corp
OTEZLA
apremilast
TABLET;ORAL205437-003Mar 21, 2014RXYesYes8,455,536► Subscribe USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
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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
7,358,272Methods 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
7,507,759Methods of using(+)-2-[1-(3-ethoxy-4methoxyphenyl)-2-methylsulfonylethyl]-- 4-acetylaminoisoindoline-1,3,-dione► Subscribe
7,659,302Methods of using (+)-2-[1-(3-ethoxy-4 methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 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
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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
Portugal1485087► Subscribe
New Zealand535798► Subscribe
MexicoPA04009075► Subscribe
South Korea20130100219► 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 500+ biopharmaceutical companies globally:

Argus Health
Cantor Fitzgerald
Daiichi Sankyo
Mallinckrodt
Chubb
Baxter
Julphar
AstraZeneca
US Department of Justice
Merck

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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