Is there a generic for Vigabatrin?

Yes. The FDA Orange Book lists 27 approved generic (ANDA) applications for Vigabatrin, referencing the brand VIGAFYDE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Vigabatrin?

VIGAFYDE (NDA 217684, PYROS PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Vigabatrin?

The Orange Book lists 3 patents against Vigabatrin products, with the earliest listed expiry in 2039. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Vigabatrin are approved?

Vigabatrin is approved in the following dosage forms: for solution, solution, tablet.

FDA Orange Book · active-ingredient family

Vigabatrin

Vigabatrin is approved as 3 brand and 27 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VIGAFYDE · NDA 217684

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · for solution, solution, tablet

Product	Applicant	Application	TE	Approved
VIGAFYDERLD	PYROS PHARMS	NDA 217684	—	Jun 17, 2024
SABRILRLD	LUNDBECK PHARMS LLC	NDA 022006	AA	Aug 21, 2009
SABRILRLD	LUNDBECK PHARMS LLC	NDA 020427	AB	Aug 21, 2009

Generic (ANDA) products (27)

Product	Applicant	Application	TE	Approved
VIGABATRIN	UPSHER SMITH LABS	ANDA 214749	AB	Jun 29, 2023
VIGABATRIN	CARNEGIE	ANDA 215519	AB	Apr 28, 2023
VIGABATRIN	ZYDUS LIFESCIENCES	ANDA 214671	—	Mar 02, 2023
VIGABATRIN	MSN	ANDA 215363	AA	Sep 07, 2022
VIGABATRIN	HIKMA	ANDA 213104	AB	Aug 29, 2022
VIGPODER	PYROS PHARMS	ANDA 214961	AA	Jun 24, 2022
VIGABATRIN	AMNEAL PHARMS	ANDA 210042	—	Jun 22, 2022
VIGABATRIN	AUROBINDO PHARMA LTD	ANDA 215601	AB	May 10, 2022
VIGABATRIN	CHARTWELL RX	ANDA 211790	—	Mar 10, 2022
VIGABATRIN	ZYDUS LIFESCIENCES	ANDA 215707	AB	Jan 19, 2022
VIGABATRIN	AUROBINDO PHARMA LTD	ANDA 213899	AA	Sep 29, 2021
VIGABATRIN	DEXCEL	ANDA 215109	AB	Sep 23, 2021
VIGABATRIN	PROPEL PHARMA	ANDA 213390	—	Jul 29, 2021
VIGABATRIN	SPECGX LLC	ANDA 212626	—	Jul 28, 2021
VIGABATRIN	DEXCEL	ANDA 214992	—	May 13, 2021
VIGABATRIN	DR REDDYS	ANDA 211539	AB	Jan 29, 2021
VIGABATRIN	ANNORA PHARMA	ANDA 213519	AA	Jan 26, 2021
VIGABATRIN	ALKEM LABS LTD	ANDA 213375	AA	Dec 02, 2020
VIGABATRIN	ACCORD HLTHCARE	ANDA 214425	—	Nov 13, 2020
VIGABATRIN	GRANULES	ANDA 213469	—	Apr 24, 2020
VIGABATRIN	INVAGEN PHARMS	ANDA 211592	AA	Dec 03, 2019
VIGABATRIN	TEVA PHARMS USA	ANDA 209822	AB	Jan 14, 2019
VIGABATRIN	DR REDDYS	ANDA 211481	AA	Nov 20, 2018
VIGADRONE	AUCTA	ANDA 210196	AA	Jun 21, 2018
VIGABATRIN	TEVA PHARMS USA	ANDA 209824	—	Apr 23, 2018
VIGABATRIN	AMNEAL PHARMS	ANDA 210155	AA	Mar 13, 2018
VIGABATRIN	PH HEALTH	ANDA 208218	AA	Apr 27, 2017

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12016857	Aug 16, 2039	in 13 yr 4 mo	Product
12290499	Oct 17, 2042	in 16 yr 7 mo	Product
12576054	Jun 08, 2043	in 17 yr 3 mo	Product

Vigabatrin — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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