Orange Book product · Brand (NDA)

RUKOBIA

FOSTEMSAVIR TROMETHAMINE

Brand (NDA)NDA 212950RX VIIV HLTHCARE

Jul 02, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 02, 2020
6 yr 1 mo ago
Today
Patent 7745625 expires
Listed drug substance patent expiration.
Nov 19, 2027
in 1 yr 5 mo
Patent 8168615 expires
Listed drug product patent expiration.
Jul 13, 2029
in 3 yr 1 mo

Active ingredient

FOSTEMSAVIR TROMETHAMINE

Strength

EQ 600MG BASE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 212950

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
7745625	Nov 19, 2027	in 1 yr 5 mo	Substance
8168615	Jul 13, 2029	in 3 yr 1 mo	Product