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Details for Patent: 7,858,122

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Patent 7,858,122 protects KEPPRA XR and is included in one NDA. There has been one Paragraph IV challenge on Keppra XR. There is one tentative approval for the compound protected by this patent. Additional details are available via the generic ingredient links below.

This patent has nineteen patent family members in seventeen countries.

Summary for Patent: 7,858,122

Title:Extended release formulation of levetiracetam
Abstract:An extended release pharmaceutical composition of Levetiracetam with once a day dosage regime and the process of preparing it. The extended release tablet of Levetiracetam is with the core comprising of Levetiracetam and water dispersible rate controlling polymer, and the tablet core is optionally functional coated comprising a combination of water non-dispersible and/or water dispersible polymer. It provides extended therapeutically effective plasma levels over a twenty four hour period with diminished incidences of neuropsychiatric adverse events by eliminating the troughs and peaks of drug concentration in a patients blood plasma, which comprises administering orally to a patient in need thereof, an extended release tablet that provides a peak blood plasma level of Levetiracetam in from about eight to about Sixteen hours. The core is prepared by Wet granulation, Dry granulation or Direct compression and optionally the tablet core is coated either in an coating pan or in and Fluidized bed system.
Inventor(s): Kshirsagar; Rajesh (Vadodara, IN), Joshi; Mayank (Vadodara, IN), Raichandani; Yogesh (Vododara, IN)
Assignee: UCB Pharma S.A. (Brussels, BE)
Application Number:11/215,947
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent Metrics:
Source: PatentQuant.com
Field: Basic materials chemistry
Back Citations: 14th percentile
Forward Citations: 6th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Ucb Inc
KEPPRA XR
levetiracetam
TABLET, EXTENDED RELEASE;ORAL022285-001Sep 12, 2008RXNo7,858,122► subscribeY
Ucb Inc
KEPPRA XR
levetiracetam
TABLET, EXTENDED RELEASE;ORAL022285-002Feb 12, 2009RXYes7,858,122► subscribeY
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Foreign Priority and PCT Information for Patent: 7,858,122

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
India81/MUM/2005Jan 27, 2005

Non-Orange Book Patents for Patent: 7,858,122

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
7,863,316Extended release formulation of Levetiracetam► 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: 7,858,122

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Norway20074316► subscribe
South Korea20070095456► subscribe
Mexico2007009088► 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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