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Details for Patent: 5,635,517

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Which drugs does patent 5,635,517 protect, and when does it expire?

Patent 5,635,517 protects POMALYST and REVLIMID and is included in two NDAs. There have been zero Paragraph IV challenges on Revlimid  and Revlimid

This patent has one hundred and ten patent family members in twenty-six countries.

Summary for Patent: 5,635,517

Title: Method of reducing TNF.alpha. levels with amino substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxo-and 1,3-dioxoisoindolines
Abstract:1-Oxo- and 1,3-dioxo-2-(2,6-dioxopiperidin-3-yl) isoindolines substituted with amino in the benzo ring reduce the levels of TNF.alpha. in a mammal. A typical embodiment is 1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-5-aminoisoindoline.
Inventor(s): Muller; George W. (Bridgewater, NJ), Stirling; David I. (Branchburg, NJ), Chen; Roger S. -C. (Edison, NJ)
Assignee: Celgene Corporation (Warren, NJ)
Application Number:08/690,258
Patent Claim Types:
see list of patent claims
Use; Compound;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-001Feb 8, 2013RXYesNo5,635,517► Subscribe USE OF POMALIDOMIDE TO INHIBIT THE SECRETION OF PRO-INFLAMMATION CYTOKINES, INCLUDING TUMOR NECROSIS FACTOR ALPHA
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-002Feb 8, 2013RXYesNo5,635,517► Subscribe USE OF POMALIDOMIDE TO INHIBIT THE SECRETION OF PRO-INFLAMMATION CYTOKINES, INCLUDING TUMOR NECROSIS FACTOR ALPHA
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 2013RXYesNo5,635,517► Subscribe USE OF POMALIDOMIDE TO INHIBIT THE SECRETION OF PRO-INFLAMMATION CYTOKINES, INCLUDING TUMOR NECROSIS FACTOR ALPHA
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-004Feb 8, 2013RXYesYes5,635,517► Subscribe USE OF POMALIDOMIDE TO INHIBIT THE SECRETION OF PRO-INFLAMMATION CYTOKINES, INCLUDING TUMOR NECROSIS FACTOR ALPHA
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-005Dec 21, 2011RXYesNo5,635,517► SubscribeY USE OF REVLIMID (LENALIDOMIDE) TO INHIBIT THE SECRETION OF PRO-INFLAMMATORY CYTOKINES, INCLUDING TUMOR NECROSIS FACTOR ALPHA
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Non-Orange Book Patents for Patent: 5,635,517

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
7,709,502Substituted 2-(2,6-dioxopiperidin-3-yl)-phthalimides and 1-oxoisoindolines► Subscribe
5,798,368 Tetrasubstituted 2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolines and method of reducing TNF.alpha. levels► Subscribe
7,459,466Substituted 2-(2,6-dioxopiperidin-3-yl)-phthalimides and -1-oxoisoindolines and method of reducing TNF.alpha. levels► Subscribe
8,158,653Pharmaceutical compositions of 1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-4-amino isoindoline► Subscribe
6,476,052 Isoindolines, method of use, and pharmaceutical compositions► 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: 5,635,517

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria229521► Subscribe
Austria275139► Subscribe
Austria401319► Subscribe
Austria460409► Subscribe
Austria500240► 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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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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