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Last Updated: March 28, 2024

VIGABATRIN Drug Patent Profile


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

Vigabatrin is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms, Annora Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Dexcel, Dr Reddys, Granules, Invagen Pharms, MSN, Par Pharm Inc, Propel Pharma, Specgx Llc, Teva Pharms Usa, Zydus, Hikma, and Upsher Smith Labs. and is included in twenty-five NDAs.

The generic ingredient in VIGABATRIN is vigabatrin. There are five drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the vigabatrin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Vigabatrin

A generic version of VIGABATRIN was approved as vigabatrin by PAR PHARM INC on April 27th, 2017.

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Drug patent expirations by year for VIGABATRIN
Recent Clinical Trials for VIGABATRIN

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SponsorPhase
AmzellPhase 3
Thomas Jefferson UniversityPhase 2
University of FloridaPhase 2

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Pharmacology for VIGABATRIN
Medical Subject Heading (MeSH) Categories for VIGABATRIN
Anatomical Therapeutic Chemical (ATC) Classes for VIGABATRIN

US Patents and Regulatory Information for VIGABATRIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare VIGABATRIN vigabatrin FOR SOLUTION;ORAL 214425-001 Nov 13, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd VIGABATRIN vigabatrin TABLET;ORAL 215601-001 May 10, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Upsher Smith Labs VIGABATRIN vigabatrin TABLET;ORAL 214749-001 Jun 29, 2023 AB 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 VIGABATRIN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
ORPHELIA Pharma SAS Kigabeq vigabatrin EMEA/H/C/004534
Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for:Treatment in monotherapy of infantile spasms (West's syndrome).Treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated.
Authorised no no no 2018-09-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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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.