raltegravir potassium · Msd Sub Merck · NDA 022145, 203045, 205786

Isentress

Earliest generic entry, as listed · earliest of 4 marketed strengths

11 Sep 2029

Other strengths are listed to 2 Jun 2030.

Blocked by patent: US 7754731 (pediatric extension).

Listed patents · 3 unexpired

4 Orange Book listing rows for 3 patents, including 1 pediatric extension. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

Patent	Claims	Expires	Notes
US 8771733	drug substance, drug product, use U-257	2 Jun 2030	2 strengths · listed 27 Mar 2023
US 7754731	drug substance, drug product, use U-257	11 Sep 2029	2 listing rows
US 7754731 listing row	drug substance, drug product, use U-257	11 Mar 2029	4 strengths · listed 20 Jan 2012
US 7754731 listing row	pediatric extension · sets the listed date	11 Sep 2029	4 strengths
US 8852632	drug substance, drug product, use U-257	28 Jan 2028	listed 27 Mar 2023

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 4

NDA · product	Form	Strength	Approved	Listed expiry
022145 · 001 · RLD	tablet, oral	EQ 400MG BASE	12 Oct 2007	2 Jun 2030
203045 · 001 · RLD	tablet, chewable, oral	EQ 25MG BASE	21 Dec 2011	11 Sep 2029
203045 · 002 · RLD	tablet, chewable, oral	EQ 100MG BASE	21 Dec 2011	2 Jun 2030
205786 · 001 · RLD	powder, oral	EQ 100MG BASE/PACKET	20 Dec 2013	11 Sep 2029