Vigabatrin - Generic Drug Details

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

Vigabatrin is the generic ingredient in five branded drugs marketed by Lundbeck Pharms Llc, Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms, Annora Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Dexcel, Dr Reddys, Endo Operations, Granules, Invagen Pharms, MSN, Propel Pharma, Specgx Llc, Teva Pharms Usa, Zydus Lifesciences, Aucta, Pyros Pharms, Hikma, Ryan Labs, and Upsher Smith Labs, and is included in thirty NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Vigabatrin has three patent family members in two countries.

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

Summary for vigabatrin

International Patents:	3
US Patents:	1
Tradenames:	5
Applicants:	22
NDAs:	30
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	30
Patent Applications:	5,859
Drug Prices:	Drug price trends for vigabatrin
What excipients (inactive ingredients) are in vigabatrin?	vigabatrin excipients list
DailyMed Link:	vigabatrin at DailyMed

See drug prices for vigabatrin

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Granules	VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	213469-001	Apr 24, 2020		DISCN	No	No
Upsher Smith Labs	VIGABATRIN	vigabatrin	TABLET;ORAL	214749-001	Jun 29, 2023	AB	RX	No	No
Teva Pharms Usa	VIGABATRIN	vigabatrin	TABLET;ORAL	209822-001	Jan 14, 2019	AB	RX	No	No
Ryan Labs	VIGABATRIN	vigabatrin	TABLET;ORAL	215519-001	Apr 28, 2023	AB	RX	No	No
Zydus Lifesciences	VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	214671-001	Mar 2, 2023		DISCN	No	No
Aucta	VIGADRONE	vigabatrin	FOR SOLUTION;ORAL	210196-001	Jun 21, 2018	AA	RX	No	No
Amneal Pharms	VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	210155-001	Mar 13, 2018	AA	RX	No	No

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

International Patents for vigabatrin

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2591389	Pharmaceuticals solution for oral dosage
World Intellectual Property Organization (WIPO)	2020039262
United Kingdom	202103724