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Last Updated: June 21, 2024

LEVETIRACETAM Drug Patent Profile


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When do Levetiracetam patents expire, and what generic alternatives are available?

Levetiracetam is a drug marketed by Adrastea Pharma, Am Regent, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly Pharm, Hikma Farmaceutica, Hospira Inc, Jubilant Generics, Micro Labs, MSN, Mylan Labs Ltd, Prinston Inc, Sagent Pharms, Sun Pharm Inds Ltd, ACI, Actavis Mid Atlantic, Alembic, Amneal Pharms, Apotex Inc, Aurobindo Pharma, Belcher, Bionpharma, Chartwell Molecular, Hetero Labs Ltd Iii, Hikma, Lupin Ltd, Pharm Assoc, Pharmobedient Cnsltg, Quagen, Strides Pharma, Taro, Tolmar, Actavis Elizabeth, Actavis Labs Fl Inc, Aiping Pharm Inc, Anchen Pharms, Anda Repository, Apotex, Aurobindo Pharma Usa, Chartwell Rx, Dexcel, Hisun Pharm Hangzhou, Lotus Pharm Co Ltd, Overseas, Pharmadax Inc, Rouses Point Pharms, Sandoz, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva Pharms, Torrent Pharms Ltd, Accord Hlthcare, Alkem Labs Ltd, Dr Reddys Labs Ltd, Fosun Pharma, Granules, Invagen Pharms, Lupin, Mylan, Nostrum Labs Inc, Orbion Pharms, Oxford Pharms, Rising, Secan Pharms, Stallion Labs, Torrent Pharms, Viwit Pharm, Watson Labs Inc, Zhejiang Jingxin, Zydus Pharms Usa Inc, B Braun Medical Inc, Baxter Hlthcare Corp, Gland Pharma Ltd, Hq Spclt Pharma, and Nexus. and is included in one hundred and two NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Levetiracetam

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

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Drug patent expirations by year for LEVETIRACETAM
Drug Prices for LEVETIRACETAM

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Drug Sales Revenue Trends for LEVETIRACETAM

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Recent Clinical Trials for LEVETIRACETAM

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SponsorPhase
University of North Carolina, Chapel HillPhase 4
AgeneBioPhase 2
Hamilton Health Sciences CorporationPhase 3

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Pharmacology for LEVETIRACETAM
Anatomical Therapeutic Chemical (ATC) Classes for LEVETIRACETAM
Paragraph IV (Patent) Challenges for LEVETIRACETAM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
KEPPRA XR Extended-release Tablets levetiracetam 1000 mg 022285 2 2011-01-07
KEPPRA Tablets levetiracetam 1000 mg 021035 1 2007-01-24

US Patents and Regulatory Information for LEVETIRACETAM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 091668-001 Nov 1, 2012 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma LEVETIRACETAM levetiracetam TABLET;ORAL 078993-002 Jan 15, 2009 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aiping Pharm Inc LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 204754-002 Aug 26, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Quagen LEVETIRACETAM levetiracetam SOLUTION;ORAL 090079-001 Apr 11, 2012 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sciegen Pharms Inc LEVETIRACETAM levetiracetam TABLET;ORAL 215069-001 Jun 11, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Prinston Inc LEVETIRACETAM levetiracetam TABLET;ORAL 078106-001 Feb 10, 2009 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 LEVETIRACETAM

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
Pharmathen S.A. Matever levetiracetam EMEA/H/C/002024
Matever 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.Matever 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
Actavis Group PTC ehf Levetiracetam Actavis levetiracetam EMEA/H/C/002355
Levetiracetam Actavis 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 Actavis 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
Actavis Group PTC ehf Levetiracetam Actavis Group levetiracetam EMEA/H/C/002305
Levetiracetam Actavis Group 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 Actavis Group is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from 1 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 2011-12-04
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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