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Last Updated: March 19, 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 Am Regent, Baxter Hlthcare Corp, Beowulf Asset, 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, Gland Pharma Ltd, Hq Spclt Pharma, and Nexus. and is included in one hundred 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
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Drug Sales Revenue Trends for LEVETIRACETAM

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Recent Clinical Trials for LEVETIRACETAM

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SponsorPhase
AgeneBioPhase 2
McMaster UniversityPhase 3
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
Prinston Inc LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 203468-002 May 21, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkem Labs Ltd LEVETIRACETAM levetiracetam TABLET;ORAL 216375-003 May 27, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Labs Fl Inc LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 091093-001 Sep 12, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msn LEVETIRACETAM levetiracetam SOLUTION;ORAL 214757-001 Jul 15, 2022 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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