Viewing data from:

SINGULAIR

NDA

MONTELUKAST SODIUM | N021409 | ORGANON LLC A SUB OF ORGANON AND CO

1 strength0 unique patents0 unique exclusivities

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

API Supply Chain25 active DMFs11 inactive

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

DELMAR CHEMICALS INCMONTELUKAST SODIUM THIOL ACID

DMF 162432002

TAPI NL BVMONTELUKAST SODIUM

DMF 198292006

MATRIX PHARMACORP PRIVATE LTDMONTELUKAST SODIUM USP

DMF 204252007

MSN PHARMACHEM PRIVATE LTDMONTELUKAST SODIUM USP [ROUTE CODE - MT"]

DMF 205802007

FORMOSA LABORATORIES INCMONTELUKAST SODIUM

DMF 217022008

MSN PHARMACHEM PRIVATE LTDMONTELUKAST SODIUM USP [ROUTE CODE - "MB"]

DMF 224842009

APOTEX INCMONTELUKAST SODIUM USP

DMF 234952010

LAURUS LABS LTDMONTELUKAST SODIUM USP

DMF 237362010

UNIMARK REMEDIES LTDMONTELUKAST SODIUM (PROCESS B)

DMF 243242010

MOREPEN LABORATORIES LTDMONTELUKAST SODIUM

DMF 244452010

DR REDDYS LABORATORIES LTDMONTELUKAST SODIUM [PROCESS-2]

DMF 245162010

HETERO DRUGS LTDMONTELUKAST SODIUM

DMF 246672011

TORRENT PHARMACEUTICALS LTDMONTELUKAST SODIUM

DMF 247212011

MACLEODS PHARMACEUTICALS LTDMONTELUKAST SODIUM

DMF 251042011

MELODY HEALTHCARE PVT LTDMONTELUKAST SODIUM

DMF 258232011

APITORIA PHARMA PRIVATE LTDMONTELUKAST SODIUM USP (NON-STERILE DRUG SUBSTANCE)

DMF 272342013

CIPLA LTDMONTELUKAST SODIUM USP

DMF 280872014

CHINA GATEWAY PHARMACEUTICAL DEVELOPMENT CO LTDMONTELUKAST SODIUM

DMF 285472014

NENTER AND CO INCMONTELUKAST SODIUM INTERMEDIATE MK5

DMF 305212016

TAPI NL BVMONTELUKAST SODIUM

DMF 314132017

ZHEJIANG TIANYU PHARMACEUTICAL CO LTDMONTELUKAST SODIUM

DMF 323072018

UNICHEM LABORATORIES LTDMONTELUKAST SODIUM USP

DMF 331632018

SHANDONG NEW TIME PHARMACEUTICAL CO LTDMONTELUKAST SODIUM USP

DMF 339732019

ZENFOLD SUSTAINABLE TECHNOLOGIES PRIVATE LTDMONTELUKAST SODIUM USP

DMF 391912023

JIANGSU ALPHA GROUP SHENGJI PHARMACEUTICAL (SUQIAN) CO LTDMONTELUKAST SODIUM INTERMEDIATE (MK-5)

DMF 418202025

DR REDDYS LABORATORIES LTDInactiveMONTELUKAST SODIUM USP

DMF 200352006

UNIMARK REMEDIES LTDInactiveMONTELUKAST SODIUM

DMF 205642007

UNIMARK REMEDIES LTDInactiveMONTELUKAST SODIUM (NI)

DMF 218932008

UNIMARK REMEDIES LTDInactiveMONTELUKAST SODIUM (PROCESS A)

DMF 238372010

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveMONTELUKAST SODIUM USP

DMF 245882011

SINTENOVO SA DE CVInactiveMONTELUKAST SODIUM

DMF 247472011

PHARMACEUTICAL WORKS POLPHARMA SAInactiveMONTELUKAST SODIUM

DMF 250612011

LG LIFE SCIENCES LTDInactiveMONTELUKAST SODIUM

DMF 255462011

NEULAND LABORATORIES LTDInactiveMONTELUKAST SODIUM

DMF 255682011

UNIMARK REMEDIES LTDInactiveMONTELUKAST SODIUM USP (PROCESS-C)

DMF 264392012

MSN PHARMACHEM PRIVATE LTDInactiveMONTELUKAST SODIUM USP [ROUTE CODE - "MK"]

DMF 270412013

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

Approval Letters

33 letters from Drugs@FDA

Date	Submission	Document
Feb 23, 2021	SUPPL -52	View Letter (PDF)
Apr 30, 2020	SUPPL -51	View Letter (PDF)
Aug 12, 2019	SUPPL -50	View Letter (PDF)
Dec 31, 2018	SUPPL -49	View Letter (PDF)
Dec 31, 2018	SUPPL -48	View Letter (PDF)
Dec 15, 2016	SUPPL -47	View Letter (PDF)
Nov 28, 2014	SUPPL -45	View Letter (PDF)
Dec 31, 2013	SUPPL -43	View Letter (PDF)
Mar 22, 2013	SUPPL -42	View Letter (PDF)
Oct 22, 2012	SUPPL -39	View Letter (PDF)
Oct 2, 2012	SUPPL -40	View Letter (PDF)
Mar 28, 2012	SUPPL -36	View Letter (PDF)
Dec 21, 2011	SUPPL -37	View Letter (PDF)
May 3, 2011	SUPPL -34	View Letter (PDF)
Aug 16, 2010	SUPPL -31	View Letter (PDF)
Apr 29, 2010	SUPPL -29	View Letter (PDF)
Nov 10, 2009	SUPPL -28	View Letter (PDF)
Jan 30, 2009	SUPPL -27	View Letter (PDF)
Apr 28, 2008	SUPPL -26	View Letter (PDF)
Apr 22, 2008	SUPPL -25	View Letter (PDF)
Mar 11, 2008	SUPPL -23	View Letter (PDF)
Apr 20, 2007	SUPPL -16	View Letter (PDF)
Dec 28, 2006	SUPPL -19	View Letter (PDF)
May 22, 2006	SUPPL -18	View Letter (PDF)
Dec 6, 2005	SUPPL -14	View Letter (PDF)
Jul 29, 2005	SUPPL -12	View Letter (PDF)
Jun 29, 2005	SUPPL -17	View Letter (PDF)
May 27, 2005	SUPPL -15	View Letter (PDF)
Nov 17, 2004	SUPPL -10	View Letter (PDF)
Dec 23, 2003	SUPPL -7	View Letter (PDF)
Oct 9, 2003	SUPPL -5	View Letter (PDF)
Jan 23, 2003	SUPPL -3	View Letter (PDF)
Jul 26, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 4MG BASE/PACKET

RLD

0 patents0 exclusivities▴

GRANULE;ORAL | Approved: Jul 26, 2002

No patent or exclusivity listings for this strength.

Change History (3)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

Organon discontinued SINGULAIR (montelukast sodium) NDA 021409, changing its product type from prescription to discontinued status.

Old: RX

New: DISCN

MODIFIEDrs7/1/2026

SINGULAIR (montelukast sodium) by Organon lost its reference-standard designation in the Orange Book.

Old: Yes

New: No

MODIFIEDTE Code7/1/2026

Organon's SINGULAIR (montelukast sodium) oral product NDA 021409 had its therapeutic equivalence code changed from AB.

Old: AB