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Last Updated: November 22, 2024

LEVETIRACETAM IN SODIUM CHLORIDE Drug Patent Profile


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

Levetiracetam In Sodium Chloride is a drug marketed by B Braun Medical Inc, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hq Spclt Pharma, and Nexus. and is included in eight NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Levetiracetam In Sodium Chloride

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

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Drug patent expirations by year for LEVETIRACETAM IN SODIUM CHLORIDE
Recent Clinical Trials for LEVETIRACETAM IN SODIUM CHLORIDE

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SponsorPhase
University of North Carolina, Chapel HillPhase 4
AgeneBioPhase 2
McMaster UniversityPhase 3

See all LEVETIRACETAM IN SODIUM CHLORIDE clinical trials

Pharmacology for LEVETIRACETAM IN SODIUM CHLORIDE

US Patents and Regulatory Information for LEVETIRACETAM IN SODIUM CHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
B Braun Medical Inc LEVETIRACETAM IN SODIUM CHLORIDE levetiracetam INJECTABLE;INTRAVENOUS 209705-001 Feb 27, 2024 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma LEVETIRACETAM IN SODIUM CHLORIDE levetiracetam INJECTABLE;INTRAVENOUS 211356-001 Feb 12, 2024 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Nexus LEVETIRACETAM IN SODIUM CHLORIDE levetiracetam INJECTABLE;INTRAVENOUS 213532-003 Jul 6, 2020 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eugia Pharma LEVETIRACETAM IN SODIUM CHLORIDE levetiracetam INJECTABLE;INTRAVENOUS 207160-002 Jan 4, 2017 AP 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 IN SODIUM CHLORIDE

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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