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Last Updated: August 10, 2020

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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 three branded drugs marketed by Lundbeck Pharms Llc, Amneal Pharms, Dr Reddys Labs Ltd, Granules Pharms, Invagen Pharms, Par Pharm Inc, Teva Pharms Usa, and Aucta, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for VIGABATRIN

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

SponsorPhase
Washington University School of MedicinePhase 2
Kullasate SakpichaisakulN/A
University of California, Los AngelesPhase 2

See all VIGABATRIN clinical trials

Pharmacology for VIGABATRIN
Medical Subject Heading (MeSH) Categories for VIGABATRIN

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
Invagen Pharms VIGABATRIN vigabatrin FOR SOLUTION;ORAL 211592-001 Dec 3, 2019 AA RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa VIGABATRIN vigabatrin FOR SOLUTION;ORAL 209824-001 Apr 23, 2018 AA RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa VIGABATRIN vigabatrin TABLET;ORAL 209822-001 Jan 14, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms VIGABATRIN vigabatrin FOR SOLUTION;ORAL 210155-001 Mar 13, 2018 AA RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd VIGABATRIN vigabatrin FOR SOLUTION;ORAL 211481-001 Nov 20, 2018 AA RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Colorcon
Johnson and Johnson
Dow
Express Scripts
Merck

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