You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 28, 2024

Vigabatrin - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

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
Yale University	Phase 2
Thomas Jefferson University	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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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
Alkem Labs Ltd	VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	213375-001	Dec 2, 2020	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Annora Pharma	VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	213519-001	Jan 26, 2021	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Specgx Llc	VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	212626-001	Jul 28, 2021		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus	VIGABATRIN	vigabatrin	TABLET;ORAL	215707-001	Jan 19, 2022	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

Subscribe to access the full database, or Try a Trial
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

Make Better Decisions: Try a trial or see plans & pricing

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.