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Last Updated: January 15, 2021

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KEPPRA Drug Profile

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When do Keppra patents expire, and when can generic versions of Keppra launch?

Keppra is a drug marketed by Ucb Inc and is included in four NDAs. There are two patents protecting this drug and three Paragraph IV challenges.

This drug has thirty patent family members in twenty-six countries.

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

US ANDA Litigation and Generic Entry Outlook for Keppra

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

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Drug patent expirations by year for KEPPRA
Drug Prices for KEPPRA

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Drug Sales Revenue Trends for KEPPRA

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Recent Clinical Trials for KEPPRA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Cambridge University Hospitals NHS Foundation TrustPhase 3
University of CambridgePhase 3
NYU Langone HealthPhase 2

See all KEPPRA clinical trials

Pharmacology for KEPPRA
Paragraph IV (Patent) Challenges for KEPPRA
Tradename Dosage Ingredient NDA Submissiondate
KEPPRA TABLET;ORAL levetiracetam 021035 2007-01-24

US Patents and Regulatory Information for KEPPRA

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 levetiracetam INJECTABLE;INTRAVENOUS 021872-001 Jul 31, 2006 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
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 levetiracetam TABLET;ORAL 021035-001 Nov 30, 1999 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
Ucb Inc KEPPRA levetiracetam SOLUTION;ORAL 021505-001 Jul 15, 2003 AA RX Yes Yes   Start Trial   Start Trial   Start Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-004 Jan 6, 2006 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-003 Nov 30, 1999 AB RX Yes No   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

Expired US Patents for KEPPRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc KEPPRA levetiracetam INJECTABLE;INTRAVENOUS 021872-001 Jul 31, 2006   Start Trial   Start Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-003 Nov 30, 1999   Start Trial   Start Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-002 Nov 30, 1999   Start Trial   Start Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-003 Nov 30, 1999   Start Trial   Start Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-004 Jan 6, 2006   Start Trial   Start Trial
Ucb Inc KEPPRA levetiracetam SOLUTION;ORAL 021505-001 Jul 15, 2003   Start Trial   Start Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-002 Nov 30, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for KEPPRA

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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKesson
Mallinckrodt
Moodys
AstraZeneca
Merck

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