VIGABATRIN - Generic Drug Details

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What are the generic drug sources for vigabatrin and what is the scope of patent protection?

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:	5,913
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
University of Florida	Phase 2
Yale 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

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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
Dexcel	VIGABATRIN	vigabatrin	TABLET;ORAL	215109-001	Sep 23, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Msn	VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	215363-001	Sep 7, 2022	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Propel Pharma	VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	213390-001	Jul 29, 2021	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	211790-001	Mar 10, 2022		DISCN	No	No	⤷ 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 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

International Patents for VIGABATRIN

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

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