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Last Updated: April 16, 2024

Vigabatrin - Generic Drug Details

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What are the generic sources for vigabatrin and what is the scope of freedom to operate?

Vigabatrin is the generic ingredient in four branded drugs marketed by Lundbeck Pharms Llc, 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, Aucta, Pyros Pharms, Hikma, and Upsher Smith Labs, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for vigabatrin. Eighteen suppliers are listed for this compound.

Summary for vigabatrin

US Patents:	0
Tradenames:	4
Applicants:	21
NDAs:	29
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	30
Patent Applications:	5,978
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in vigabatrin?	vigabatrin excipients list
DailyMed Link:	vigabatrin at DailyMed

Recent Clinical Trials for vigabatrin

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

Sponsor	Phase
Amzell	Phase 3
Thomas Jefferson University	Phase 2
University of Florida	Phase 2

See all vigabatrin clinical trials

Pharmacology for vigabatrin

Drug Class	Anti-epileptic Agent

Medical Subject Heading (MeSH) Categories for vigabatrin

Anticonvulsants
Enzyme Inhibitors
GABA Agents

Anatomical Therapeutic Chemical (ATC) Classes for vigabatrin

N03AG	Fatty acid derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for vigabatrin

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pyros Pharms	VIGPODER	vigabatrin	FOR SOLUTION;ORAL	214961-001	Jun 24, 2022	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Par Pharm Inc	VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	208218-001	Apr 27, 2017	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Propel Pharma	VIGABATRIN	vigabatrin	TABLET;ORAL	215519-001	Apr 28, 2023	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
Hikma	VIGABATRIN	vigabatrin	TABLET;ORAL	213104-001	Aug 29, 2022	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Accord Hlthcare	VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	214425-001	Nov 13, 2020		DISCN	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

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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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