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Last Updated: October 1, 2022

KEPPRA XR Drug Patent 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. Eighty-four suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.

DrugPatentWatch® 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

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

SponsorPhase
Sohag UniversityPhase 2
Myrtelle Inc.Phase 1/Phase 2
CureRareDisease LLCPhase 1/Phase 2

See all KEPPRA XR clinical trials

Pharmacology for KEPPRA XR
Anatomical Therapeutic Chemical (ATC) Classes for KEPPRA XR
Paragraph IV (Patent) Challenges for KEPPRA XR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
KEPPRA XR Extended-release Tablets levetiracetam 1000 mg 022285 2 2011-01-07

US Patents and Regulatory Information for KEPPRA XR

KEPPRA XR is protected by one US patents.

Patents protecting KEPPRA XR

Extended release formulation of levetiracetam
Patent Number: See Plans and Pricing
Patent Expiration: 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
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 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for KEPPRA XR

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
UCB Pharma SA Keppra levetiracetam EMEA/H/C/000277
Keppra is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Keppra is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Authorised no no no 2000-09-29
Pfizer Europe MA EEIG Levetiracetam Hospira levetiracetam EMEA/H/C/002783
Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.Levetiracetam Hospira is indicated as adjunctive therapyin the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.
Authorised yes no no 2014-01-07
Accord Healthcare S.L.U. Levetiracetam Accord levetiracetam EMEA/H/C/002290
Levetiracetam is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Levetiracetam is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Authorised yes no no 2011-10-03
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for KEPPRA XR

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

Country Patent Number Title Estimated Expiration
China 101111245 Extended release formulation of levetiracetam See Plans and Pricing
Poland 147387 See Plans and Pricing
U.S.S.R. 1320207 ПPABOBPAЩAЮЩИЙ ЭHAHTИOMEP ( )- -ЭTИЛ-2-OKCO-1-ПИPPOЛИДИHAЦETAMИД,OБЛAДAЮЩИЙ MHEЗИЧECKOЙ AKTИBHOCTЬЮ (DEXTROROTATORY ENANTHIOMER OR (R)-ALPHA-ETHYL-2-OXO-1-PYRROLIDINEACETAMIDE POSSESSING MNESIC ACTIVITY) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KEPPRA XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0162036 SPC/GB00/030 United Kingdom See Plans and Pricing SPC/GB00/030: 20050514, EXPIRES: 20100514
0162036 C300028 Netherlands See Plans and Pricing 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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