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Last Updated: July 6, 2020

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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.

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

US ANDA Litigation and Generic Entry Outlook for Keppra Xr

A generic version of KEPPRA XR was approved as levetiracetam by MYLAN on November 4th, 2008.

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Drug patent expirations by year for KEPPRA XR
Drug Prices for KEPPRA XR

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Drug Sales Revenue Trends for KEPPRA XR

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Recent Clinical Trials for KEPPRA XR

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SponsorPhase
NYU Langone HealthPhase 2
Vanderbilt University Medical CenterPhase 2
Walter Reed National Military Medical CenterPhase 2

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Pharmacology for KEPPRA XR
Paragraph IV (Patent) Challenges for KEPPRA XR
Tradename Dosage Ingredient NDA Submissiondate
KEPPRA XR TABLET, EXTENDED RELEASE;ORAL levetiracetam 022285 2011-01-07

US Patents and Regulatory Information for KEPPRA XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ucb Inc KEPPRA XR levetiracetam TABLET, EXTENDED RELEASE;ORAL 022285-001 Sep 12, 2008 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Ucb Inc KEPPRA XR levetiracetam TABLET, EXTENDED RELEASE;ORAL 022285-002 Feb 12, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for KEPPRA XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0162036 2000C/032 Belgium   Start Trial PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329
0162036 C300028 Netherlands   Start Trial PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929
0162036 SPC/GB00/030 United Kingdom   Start Trial SPC/GB00/030: 20050514, EXPIRES: 20100514
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Moodys
McKesson
Boehringer Ingelheim
Baxter
Merck

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