Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

McKesson
McKinsey
AstraZeneca
Dow
Moodys
Baxter

Last Updated: December 7, 2022

Levetiracetam - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


What are the generic drug sources for levetiracetam and what is the scope of freedom to operate?

Levetiracetam is the generic ingredient in six branded drugs marketed by Ucb Inc, Akorn, Am Regent, Beowulf Asset, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly Pharm, Hikma Farmaceutica, Hospira Inc, Jubilant Generics, Micro Labs, Mylan Labs Ltd, Prinston Inc, Sagent Pharms, Sun Pharm Inds Ltd, Gland Pharma Ltd, Hq Speciality Pharma, Nexus Pharms, ACI, Actavis Mid Atlantic, Aiping Pharm Inc, Alembic Labs, Amneal Pharms, Apotex Inc, Aurobindo Pharma, Belcher, Breckenridge, Chartwell Molecular, Hetero Labs Ltd Iii, Lupin Ltd, MSN, Pharm Assoc, Taro, Tolmar, Wockhardt Bio Ag, Tripoint, Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Anda Repository, Apotex, Florida, Hisun Pharm Hangzhou, Lotus Pharm Co Ltd, Mylan Pharms Inc, Overseas, Pharmadax Inc, Rouses Point Pharms, Sandoz, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva Pharms, Torrent Pharms Ltd, Aprecia Pharms, Accord Hlthcare, Alkem Labs Ltd, Chartwell Rx, Dr Reddys Labs Ltd, Fosun Pharma, Invagen Pharms, Lupin, Mylan, Nostrum Labs Inc, Orbion Pharms, Oxford Pharms, Secan Pharms, Stallion Labs, Torrent Pharms, Viwit Pharm, Vkt Pharma, Watson Labs Inc, Zhejiang Jingxin, and Zydus Pharms Usa Inc, and is included in one hundred and one NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Levetiracetam has ninety-four patent family members in thirty countries.

There are thirty-five drug master file entries for levetiracetam. Eighty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for levetiracetam

See drug prices for levetiracetam

Drug Sales Revenue Trends for levetiracetam

See drug sales revenues for levetiracetam

Recent Clinical Trials for levetiracetam

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

SponsorPhase
All India Institute of Medical Sciences, New DelhiPhase 2/Phase 3
Sohag UniversityPhase 2
Janssen Research & Development, LLCPhase 2

See all levetiracetam clinical trials

Generic filers with tentative approvals for LEVETIRACETAM
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing1GMTABLET;ORAL
See Plans and PricingSee Plans and Pricing750MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing250MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology 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
Stallion Labs LEVETIRACETAM levetiracetam TABLET;ORAL 079042-002 Jan 15, 2009 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rouses Point Pharms LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 202524-001 Aug 27, 2012 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hisun Pharm Hangzhou LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 207175-001 Sep 28, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actavis Labs Fl Inc LEVETIRACETAM levetiracetam TABLET;ORAL 077408-001 Mar 2, 2009 DISCN No No See Plans and Pricing See Plans and Pricing 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 levetiracetam

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-001 Jul 31, 2015 See Plans and Pricing See Plans and Pricing
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-003 Jul 31, 2015 See Plans and Pricing See Plans and Pricing
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-002 Jul 31, 2015 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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

Supplementary Protection Certificates for levetiracetam

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 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
McKinsey
Merck
Johnson and Johnson
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.