Viewing data from:

ISENTRESS

NDA

RALTEGRAVIR POTASSIUM | N203045 | MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC

2 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)TodayPED (+6 mo)

2027

2028

2029

2030

Today

7754731

Sep. 11, 2029

8771733

Jun. 2, 2030

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

17 letters from Drugs@FDA

Date	Submission	Document
May 19, 2021	SUPPL -17	View Letter (PDF)
Jul 17, 2020	SUPPL -16	View Letter (PDF)
Mar 12, 2018	SUPPL -15	View Letter (PDF)
Dec 6, 2017	SUPPL -14	View Letter (PDF)
May 31, 2017	SUPPL -13	View Letter (PDF)
Feb 24, 2015	SUPPL -12	View Letter (PDF)
Feb 19, 2015	SUPPL -11	View Letter (PDF)
Apr 10, 2014	SUPPL -10	View Letter (PDF)
Dec 31, 2013	SUPPL -9	View Letter (PDF)
Oct 25, 2013	SUPPL -8	View Letter (PDF)
Aug 6, 2013	SUPPL -7	View Letter (PDF)
Jul 2, 2013	SUPPL -4	View Letter (PDF)
Apr 9, 2013	SUPPL -5	View Letter (PDF)
Aug 15, 2012	SUPPL -3	View Letter (PDF)
Apr 23, 2012	SUPPL -2	View Letter (PDF)
Apr 2, 2012	SUPPL -1	View Letter (PDF)
Dec 27, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 25MG BASE

RLD

1 patent0 exclusivities▴

TABLET, CHEWABLE;ORAL | Approved: Dec 21, 2011

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7754731	Mar 11, 2029PED: Sep 11, 2029	PED	Yes	Yes		—

#002 — EQ 100MG BASE

RLD

2 patents0 exclusivities▾

TABLET, CHEWABLE;ORAL | Approved: Dec 21, 2011