Orange Book product · Brand (NDA)

VIGAFYDE

VIGABATRIN

Brand (NDA)NDA 217684RX PYROS PHARMS

Jun 17, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 17, 2024
2 yr ago
Today
Patent 12016857 expires
Listed drug product patent expiration.
Aug 16, 2039
in 13 yr 4 mo
Patent 12290499 expires
Listed drug product patent expiration.
Oct 17, 2042
in 16 yr 7 mo
Patent 12576054 expires
Listed drug product patent expiration.
Jun 08, 2043
in 17 yr 3 mo

Active ingredient

VIGABATRIN

Strength

100MG/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 217684

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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