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Last Updated: May 21, 2022

KEPPRA Drug Patent 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 one Paragraph IV challenge.

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. Eighty-one suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.

DrugPatentWatch® 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
Sohag UniversityPhase 2
CureRareDisease LLCPhase 1/Phase 2
Myrtelle Inc.Phase 1/Phase 2

See all KEPPRA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for KEPPRA
Paragraph IV (Patent) Challenges for KEPPRA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
KEPPRA Tablets levetiracetam 1000 mg 021035 1 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ucb Inc KEPPRA XR levetiracetam TABLET, EXTENDED RELEASE;ORAL 022285-001 Sep 12, 2008 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-001 Nov 30, 1999 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ucb Inc KEPPRA XR levetiracetam TABLET, EXTENDED RELEASE;ORAL 022285-002 Feb 12, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ucb Inc KEPPRA levetiracetam SOLUTION;ORAL 021505-001 Jul 15, 2003 AA RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-004 Jan 6, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-003 Nov 30, 1999 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 TABLET;ORAL 021035-003 Nov 30, 1999 See Plans and Pricing See Plans and Pricing
Ucb Inc KEPPRA levetiracetam SOLUTION;ORAL 021505-001 Jul 15, 2003 See Plans and Pricing See Plans and Pricing
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-002 Nov 30, 1999 See Plans and Pricing See Plans and Pricing
Ucb Inc KEPPRA levetiracetam INJECTABLE;INTRAVENOUS 021872-001 Jul 31, 2006 See Plans and Pricing See Plans and Pricing
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-001 Nov 30, 1999 See Plans and Pricing See Plans and Pricing
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-004 Jan 6, 2006 See Plans and Pricing See Plans and Pricing
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-003 Nov 30, 1999 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for KEPPRA

See the table below for patents covering KEPPRA around the world.

Country Patent Number Title Estimated Expiration
Denmark 212985 See Plans and Pricing
Georgia, Republic of P20002001 (S)-alfa-ethyl-2-oxo-1-pyrolidinacetamide See Plans and Pricing
South Korea 920003819 See Plans and Pricing
Australia 4252985 See Plans and Pricing
Poland 253374 See Plans and Pricing
Spain 8703419 See Plans and Pricing
New Zealand 554157 Pharmaceutical compositions comprising levetiracetam and process for their preparation See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KEPPRA

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