Orange Book product · Brand (NDA)

ISENTRESS

RALTEGRAVIR POTASSIUM

Brand (NDA)NDA 022145RX MSD SUB MERCK

Oct 12, 2007

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 12, 2007
19 yr ago
Today
Patent 8852632 expires
Listed drug substance patent expiration.
Jan 28, 2028
in 1 yr 8 mo
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
Patent 8771733 expires
Listed drug substance patent expiration.
Jun 02, 2030
in 4 yr

Active ingredient

RALTEGRAVIR POTASSIUM

Strength

EQ 400MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 022145

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
8852632	Jan 28, 2028	in 1 yr 8 mo	SubstanceProductU-257
7754731	Mar 11, 2029	in 2 yr 9 mo	SubstanceProductU-257
7754731*PED	Sep 11, 2029	in 3 yr 3 mo
8771733	Jun 02, 2030	in 4 yr	SubstanceProductU-257