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KEPPRA XR Drug Profile

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Keppra Xr is a drug marketed by Ucb Inc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has nineteen patent family members in seventeen countries.

The generic ingredient in KEPPRA XR is levetiracetam. There are thirty-four drug master file entries for this compound. Ninety suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the levetiracetam profile page.

Summary for Tradename: KEPPRA XR

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: KEPPRA XR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ucb Inc
KEPPRA XR
levetiracetam
TABLET, EXTENDED RELEASE;ORAL022285-001Sep 12, 2008RXNo7,858,122► subscribeY ► subscribe
Ucb Inc
KEPPRA XR
levetiracetam
TABLET, EXTENDED RELEASE;ORAL022285-002Feb 12, 2009RXYes7,858,122► subscribeY ► subscribe
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Expired Patents for Tradename: KEPPRA XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc
KEPPRA XR
levetiracetam
TABLET, EXTENDED RELEASE;ORAL022285-001Sep 12, 20084,943,639*PED► subscribe
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Paragraph IV activity for: KEPPRA XR

Drugname Dosage Strength RLD Submissiondate
levetiracetamExtended-release Tablets1000 mgKeppra XR1/7/2011

Non-Orange Book Patents for Tradename: KEPPRA XR

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 Tradename: KEPPRA XR

Country Document Number Estimated Expiration
South Africa200707250► subscribe
Canada2595988► subscribe
Norway20074316► 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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Supplementary Protection Certificates for Tradename: KEPPRA XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00C/032Belgium► subscribePRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329
00028Netherlands► subscribePRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929
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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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