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Last Updated: November 4, 2024

SABRIL Drug Patent Profile


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

Sabril is a drug marketed by Lundbeck Pharms Llc and is included in two NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Sabril

A generic version of SABRIL was approved as vigabatrin by ENDO OPERATIONS on April 27th, 2017.

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Summary for SABRIL
Drug patent expirations by year for SABRIL
Drug Prices for SABRIL

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Recent Clinical Trials for SABRIL

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

SponsorPhase
Washington University School of MedicinePhase 2
Kullasate SakpichaisakulN/A
Benuvia Therapeutics Inc.Phase 3

See all SABRIL clinical trials

Pharmacology for SABRIL

US Patents and Regulatory Information for SABRIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lundbeck Pharms Llc SABRIL vigabatrin FOR SOLUTION;ORAL 022006-001 Aug 21, 2009 AA RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lundbeck Pharms Llc SABRIL vigabatrin TABLET;ORAL 020427-001 Aug 21, 2009 AB RX Yes Yes ⤷  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 SABRIL

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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