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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fuji
Argus Health
Mallinckrodt
McKinsey
Novartis
Teva
AstraZeneca
Cantor Fitzgerald
Daiichi Sankyo

Generated: December 18, 2017

DrugPatentWatch Database Preview

KEPPRA XR Drug Profile

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Which patents cover Keppra Xr, and when can generic versions of Keppra Xr launch?

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

This drug has nineteen patent family members in seventeen countries and two supplementary protection certificates in two countries.

The generic ingredient in KEPPRA XR is levetiracetam. There are thirty-five drug master file entries for this compound. One hundred suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ucb IncKEPPRA XRlevetiracetamTABLET, EXTENDED RELEASE;ORAL022285-001Sep 12, 2008ABRXYesNo► Subscribe► SubscribeY► Subscribe
Ucb IncKEPPRA XRlevetiracetamTABLET, EXTENDED RELEASE;ORAL022285-002Feb 12, 2009ABRXYesYes► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges 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
Israel184822► Subscribe
Australia2005325930► Subscribe
China101111245► Subscribe
Norway20074316► Subscribe
New Zealand556630► Subscribe
Japan2008528571► Subscribe
Japan5739080► Subscribe
World Intellectual Property Organization (WIPO)2006080029► Subscribe
Spain2294979► 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
00028Netherlands► SubscribePRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929
00C/032Belgium► SubscribePRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329
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Serving leading biopharmaceutical companies globally:

US Army
Daiichi Sankyo
McKesson
Dow
Argus Health
Merck
Fish and Richardson
Johnson and Johnson
Chubb
Citi

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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