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Last Updated: July 2, 2022

Levetiracetam - Generic Drug Details


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What are the generic sources for levetiracetam and what is the scope of patent protection?

Levetiracetam is the generic ingredient in six branded drugs marketed by Ucb Inc, Akorn, Am Regent, 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, Xgen Pharms, Gland Pharma Ltd, Hq Speciality Pharma, Nexus Pharms, ACI, Actavis Mid Atlantic, Alembic Labs, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Breckenridge, Chartwell Molecular, Genus, Hetero Labs Ltd Iii, Lupin Ltd, Pharm Assoc, Taro, Tolmar, Tris Pharma Inc, Wockhardt Bio Ag, Tripoint, Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Anda Repository, Apotex, Florida, Genus Lifesciences, 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, Virtus Pharms, Aprecia Pharms, Accord Hlthcare, Alkem Labs Ltd, Aurobindo Pharma, 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 ninety-nine 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

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Drug Sales Revenue Trends for levetiracetam

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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 Pricing500MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing1GMTABLET;ORAL
See Plans and PricingSee Plans and Pricing750MGTABLET;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
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
Nostrum Labs Inc LEVETIRACETAM levetiracetam TABLET;ORAL 090511-004 Aug 18, 2011 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-002 Jul 31, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Invagen Pharms LEVETIRACETAM levetiracetam TABLET;ORAL 078234-001 Jan 15, 2009 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Oxford Pharms LEVETIRACETAM levetiracetam TABLET;ORAL 077319-003 Mar 20, 2009 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms LEVETIRACETAM levetiracetam TABLET;ORAL 078101-001 Jan 15, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lotus Pharm Co Ltd LEVETIRACETAM levetiracetam TABLET;ORAL 090906-004 Oct 31, 2016 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Inds Ltd LEVETIRACETAM levetiracetam INJECTABLE;INTRAVENOUS 090754-001 Jun 16, 2010 AP RX 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
Ucb Inc KEPPRA XR levetiracetam TABLET, EXTENDED RELEASE;ORAL 022285-001 Sep 12, 2008 See Plans and Pricing See Plans and Pricing
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-004 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
Ucb Inc KEPPRA levetiracetam SOLUTION;ORAL 021505-001 Jul 15, 2003 See Plans and Pricing See Plans and Pricing
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-003 Nov 30, 1999 See Plans and Pricing See Plans and Pricing
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-001 Jul 31, 2015 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
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
Sun Pharmaceutical Industries Europe B.V. Levetiracetam Sun levetiracetam EMEA/H/C/002051
Levetiracetam Sun 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 Sun is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults and children from four 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 Sun concentrate is an alternative for patients when oral administration is temporarily not feasible.
Authorised yes no no 2011-12-14
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for levetiracetam

Country Patent Number Title Estimated Expiration
Australia 2006274263 Pharmaceutical compositions comprising levetiracetam and process for their preparation See Plans and Pricing
Spain 2688880 See Plans and Pricing
Japan 5739080 See Plans and Pricing
Mexico 2007004294 COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN LEVETIRACETAM Y PROCESO PARA SU PREPARACION. (PHARMACEUTICAL COMPOSITIONS COMPRISING LEVETIRACETAM AND PROCESS FOR THEIR PREPARATION.) See Plans and Pricing
Brazil PI0518506 tablete e formulaÇço de liberaÇço prolongada de levetiracetam See Plans and Pricing
Canada 2595988 FORMULATION DE LEVETIRACETAM A LIBERATION PROLONGEE (EXTENDED RELEASE FORMULATION OF LEVETIRACETAM) See Plans and Pricing
Japan 5183470 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for levetiracetam

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0162036 C300028 Netherlands See Plans and Pricing PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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