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Last Updated: March 29, 2024

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 twenty-nine patent family members in twenty-five countries.

The generic ingredient in KEPPRA 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

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

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

See all KEPPRA clinical trials

Pharmacology for KEPPRA
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc KEPPRA XR levetiracetam TABLET, EXTENDED RELEASE;ORAL 022285-001 Sep 12, 2008 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-001 Nov 30, 1999 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-003 Nov 30, 1999 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-001 Nov 30, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for KEPPRA

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

Supplementary Protection Certificates for KEPPRA

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