Orange Book product · Brand (NDA)

ISENTRESS

RALTEGRAVIR POTASSIUM

Brand (NDA)NDA 205786RX MSD SUB MERCK

Dec 20, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 20, 2013
12 yr 8 mo ago
Today
Patent 7754731 expires
Listed drug substance patent expiration.
Mar 11, 2029
in 2 yr 9 mo
Patent 7754731*PED expires
Listed listed patent expiration.
Sep 11, 2029
in 3 yr 3 mo

Active ingredient

RALTEGRAVIR POTASSIUM

Strength

EQ 100MG BASE/PACKET

Dosage form

POWDER

Route

ORAL

TE code

Not listed

Application

NDA 205786

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
7754731	Mar 11, 2029	in 2 yr 9 mo	SubstanceProductU-257
7754731*PED	Sep 11, 2029	in 3 yr 3 mo