Orange Book product · Brand (NDA)

SESQUIENT

FOSPHENYTOIN SODIUM

Brand (NDA)NDA 210864DISCN LUPIN

Nov 05, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 05, 2020
5 yr 8 mo ago
Today
Patent 7635773 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 8410077 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 9200088 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 9750822 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 9493582 expires
Listed drug product patent expiration.
Feb 27, 2033
in 6 yr 10 mo

Active ingredient

FOSPHENYTOIN SODIUM

Strength

EQ 100MG PHENYTOIN NA/2ML (EQ 50MG PHENYTOIN NA/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 210864

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
7635773	Mar 13, 2029	in 2 yr 9 mo	Product
8410077	Mar 13, 2029	in 2 yr 9 mo	Product
9200088	Mar 13, 2029	in 2 yr 9 mo	Product
9750822	Mar 13, 2029	in 2 yr 9 mo	Product
9493582	Feb 27, 2033	in 6 yr 10 mo	Product