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Last Updated: March 28, 2024

VIGADRONE Drug Patent Profile


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

Vigadrone is a drug marketed by Aucta and is included in one NDA.

The generic ingredient in VIGADRONE 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 Vigadrone

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

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Summary for VIGADRONE
Drug patent expirations by year for VIGADRONE
Pharmacology for VIGADRONE
Anatomical Therapeutic Chemical (ATC) Classes for VIGADRONE

US Patents and Regulatory Information for VIGADRONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aucta VIGADRONE vigabatrin FOR SOLUTION;ORAL 210196-001 Jun 21, 2018 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 VIGADRONE

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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