Viewing data from:

ISENTRESS

NDA

RALTEGRAVIR POTASSIUM | N022145 | MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC

2 strengths5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)TodayPED (+6 mo)

2027

2028

2029

2030

2031

2032

Today

Sep. 11, 2029

Jun. 2, 2030

Jan. 28, 2028

Apr. 21, 2031

Mar. 30, 2032

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

214 trials from ClinicalTrials.gov — 1 recruiting, 167 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission NCT02140255	Phase 1/2	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	1,120	2015-01-23 → 2031-12-31
Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (0518-023)NCT00377065	—	APPROVED_FOR_MARKETING	Merck Sharp & Dohme LLC	—	—
Raltegravir for HAM/TSP NCT01867320	Early Phase 1	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	19	2013-09-05 → 2018-09-25
A Two Way Cross Over Pharmacokinetic Interaction Study Between Raltegravir and Amlodipine in Healthy Volunteers NCT01841593	Phase 1	Completed	St Stephens Aids Trust	19	2013-04 → 2013-09
QDISS Stud: QD Isentress as Switch Strategy in Virologically Suppressed HIV-1 Infected-Patient NCT03195452	Phase 2	Completed	Nantes University Hospital	100	2017-11-08 → 2020-05-06
Buprenorphine/Raltegravir Pharmacokinetic Interaction Study NCT00858962	N/A	Completed	Yale University	12	2009-03 → 2009-12
Pharmacokinetic Study of Raltegravir in Human Immunodeficiency Virus/Hepatitis C Virus (HIV/VHC) Coinfected Patients With Advanced (Child-Pugh C) Hepatic Cirrhosis NCT01289951	Phase 1	Completed	Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal	10	2010-12 → 2011-10
Study to Characterize the Pharmacokinetics of Raltegravir in the Gastrointestinal (GI) Tract of Healthy Male Volunteers NCT01325051	Phase 1	Completed	Angela Kashuba, PharmD	15	2011-04 → 2011-11
A Pharmacokinetic Study to Evaluate the Effect of Antacids on Raltegravir (MK-0518) in HIV-Infected Participants (MK-0518-247)NCT01622673	Phase 1	Completed	Merck Sharp & Dohme LLC	27	2012-06 → 2012-10
Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid NCT00729924	Phase 2/3	Completed	Vanderbilt University	40	2008-08 → 2011-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$34.49

per ea

Lowest NADAC/Unit

$34.48

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00006308001ISENTRESS HD 600 MG TABLET	$34.49	EA	Brand	—	2026-06-17
00006022761ISENTRESS 400 MG TABLET	$34.48	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$1445.10

Highest Price

$2051.75

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00006-0227-61ISENTRESS 400MG TAB	$2051.75	FSS	Merck Sharp & Dohme LLC	05/31/2030
00006-0227-61ISENTRESS 400MG TAB	$1468.85	Big4	Merck Sharp & Dohme LLC	05/31/2030
00006-3080-01ISENTRESS HD 600MG TAB	$2051.75	FSS	Merck Sharp & Dohme LLC	05/31/2030
00006-3080-01ISENTRESS HD 600MG TAB	$1445.10	Big4	Merck Sharp & Dohme LLC	05/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Isentress (2024)

Total Spending

$112.7M

Total Claims

53,765

Beneficiaries

7,188

Avg Cost/Unit

$33.14

Spending Trend

$214.4M(2019)→$188.3M(2020)→$164.4M(2021)→$146.2M(2022)→$130.5M(2023)→$112.7M(2024)

YoY Change:-1.1%

5yr CAGR:+4.2%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain7 active DMFs3 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

MATRIX PHARMACORP PRIVATE LTDRALTEGRAVIR POTASSIUM

DMF 277282013

MATRIX PHARMACORP PRIVATE LTDRALTEGRAVIR POTASSIUM USP (PROCESS-II)

DMF 305952016

LUPIN MANUFACTURING SOLUTIONS LTDRALTEGRAVIR POTASSIUM USP (CRYSTALLINE)

DMF 342062019

MAITHRI DRUGS PRIVATE LTDRALTEGRAVIR POTASSIUM USP

DMF 360832021

HETERO DRUGS LTDRALTEGRAVIR POTASSIUM (FORM-III)

DMF 371822022

APITORIA PHARMA PRIVATE LTDRALTEGRAVIR POTASSIUM USP

DMF 393152023

APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC)RALTEGRAVIR POTASSIUM USP

DMF 432352025

HETERO DRUGS LTDInactiveRALTEGRAVIR POTASSIUM

DMF 252612011

LUPIN LTDInactiveRALTEGRAVIR POTASSIUM USP

DMF 257532012

EMCURE PHARMACEUTICALS LTDInactiveRALTEGRAVIR POTASSIUM

DMF 269352013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

32 letters from Drugs@FDA

Date	Submission	Document
May 19, 2021	SUPPL -44	View Letter (PDF)
Jul 17, 2020	SUPPL -42	View Letter (PDF)
Jun 20, 2018	SUPPL -39	View Letter (PDF)
Mar 15, 2018	SUPPL -38	View Letter (PDF)
Dec 6, 2017	SUPPL -37	View Letter (PDF)
May 31, 2017	SUPPL -36	View Letter (PDF)
Feb 24, 2015	SUPPL -35	View Letter (PDF)
Feb 19, 2015	SUPPL -34	View Letter (PDF)
Apr 10, 2014	SUPPL -32	View Letter (PDF)
Dec 31, 2013	SUPPL -31	View Letter (PDF)
Oct 25, 2013	SUPPL -30	View Letter (PDF)
Aug 6, 2013	SUPPL -29	View Letter (PDF)
Jul 2, 2013	SUPPL -27	View Letter (PDF)
Apr 9, 2013	SUPPL -28	View Letter (PDF)
Aug 15, 2012	SUPPL -26	View Letter (PDF)
Apr 23, 2012	SUPPL -23	View Letter (PDF)
Apr 2, 2012	SUPPL -21	View Letter (PDF)
Dec 28, 2011	SUPPL -22	View Letter (PDF)
Nov 7, 2011	SUPPL -20	View Letter (PDF)
Jun 17, 2011	SUPPL -15	View Letter (PDF)
Apr 13, 2011	SUPPL -18	View Letter (PDF)
Mar 1, 2011	SUPPL -17	View Letter (PDF)
Jul 2, 2010	SUPPL -11	View Letter (PDF)
Jul 2, 2010	SUPPL -12	View Letter (PDF)
Apr 2, 2010	SUPPL -14	View Letter (PDF)
Jan 20, 2010	SUPPL -13	View Letter (PDF)
Jul 15, 2009	SUPPL -4	View Letter (PDF)
Feb 9, 2009	SUPPL -1	View Letter (PDF)
Feb 3, 2009	SUPPL -1	View Letter (PDF)
Jan 14, 2009	SUPPL -6	View Letter (PDF)
Oct 28, 2008	SUPPL -3	View Letter (PDF)
Oct 22, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 400MG BASE

RLD

3 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 12, 2007

Patents (3) · 3 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
7754731	Mar 11, 2029PED: Sep 11, 2029	PED	Yes	Yes	—
8771733	Jun 2, 2030	—	Yes	Yes	—
8852632	Jan 28, 2028	—	Yes	Yes	—

#002 — EQ 600MG BASE

RLDAB

4 patents0 exclusivities▾

TABLET;ORAL | Approved: May 26, 2017