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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Isentress (2023)

Total Spending

$130.5M

Total Claims

61,413

Beneficiaries

7,475

Avg Cost/Unit

$33.53

Spending Trend

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

YoY Change:+5.7%

5yr CAGR:+6.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain8 active DMFs2 inactive

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

HETERO DRUGS LTDRALTEGRAVIR POTASSIUM

DMF 252612011

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

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)

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