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Last Updated: October 20, 2019

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SINGULAIR Drug Profile

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When do Singulair patents expire, and what generic alternatives are available?

Singulair is a drug marketed by Merck and Msd Merck Co and is included in three NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has twenty-eight patent family members in twenty-five countries.

The generic ingredient in SINGULAIR is montelukast sodium. There are thirty-five drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.

Drug patent expirations by year for SINGULAIR
Drug Prices for SINGULAIR

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Drug Sales Revenue Trends for SINGULAIR

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Recent Clinical Trials for SINGULAIR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Pharmtechnology LLCPhase 1
ClinPharmInvest, LLCPhase 1
National Institutes of Health (NIH)Phase 2

See all SINGULAIR clinical trials

Recent Litigation for SINGULAIR

Identify potential future generic entrants

District Court Litigation
Case NameDate
MERCK FROSST CANADA & CO. v. DR. REDDY'S LABORATORIES, LTD.2012-03-02
MERCK FROSST CANADA & CO. v. MYLAN PHARMACEUTICALS INC.2011-12-29
DISTRICT COUNCIL 37 HEALTH & SECURITY PLAN v. MERCK SHARP & DOHME PHARMACEUTICALS SRL2009-08-12

See all SINGULAIR litigation

Pharmacology for SINGULAIR
Synonyms for SINGULAIR
(R-(E))-1-(((1-(3-(2-(7-Chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetic acid
(R,E)-2-(1-(((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propyl)thio)methyl)cyclopropyl)acetic acid
{1-[({(1R)-1-{3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl}-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl}sulfanyl)methyl]cyclopropyl}acetic acid
{1-[({(1R)-1-{3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl}-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl}sulfanyl)methyl]cyclopropyl}acetic acid
1-((((1R)-1-(3-((1E)-2-(7-Chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetic acid
1-[[[(1 R)-1-[3-[(1E)-2-(7-chloro-2-quinolinyl)ethenyl] phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]sulfanyl]methyl]cyclopropaneacetic acid
1-[[[(R)-3-[2-(1-Hydroxy-1-methylethyl)phenyl]-1-[3-[2-(7-chloroquinoline-2-yl)ethenyl]phenyl]propyl]thio]methyl]cyclopropane-1-acetic acid
142522-28-9
151767-02-1 (sodium)
158966-92-8
2-[1-({[(1R)-1-{3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl}-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanyl}methyl)cyclopropyl]acetic acid
2-[1-[[(1R)-1-[3-[(E)-2-(7-chloro-2-quinolyl)vinyl]phenyl]-3-[2-(1-hydroxy-1-methyl-ethyl)phenyl]propyl]sulfanylmethyl]cyclopropyl]acetic acid
2-[1-[[(1R)-1-[3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanylmethyl]cyclopropyl]acetic acid
2-[1-[[(1R)-1-[3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanylmethyl]cyclopropyl]ethanoic acid
522M289
5306-EP2270008A1
5306-EP2276739A1
5306-EP2280006A1
5306-EP2281813A1
5306-EP2281815A1
5306-EP2281819A1
5306-EP2284166A1
5306-EP2287154A1
5306-EP2288595A2
5306-EP2292617A1
5306-EP2292619A1
5306-EP2295409A1
5306-EP2298415A1
5306-EP2301933A1
5306-EP2305640A2
5306-EP2305659A1
5306-EP2308562A2
5306-EP2311818A1
5306-EP2311827A1
5306-EP2314590A1
AB01275454-01
AC1NQXXW
ACT04773
Aerokast
AKOS025310659
AN-31084
BCP28542
BDBM50052024
BIDD:GT0394
BRD-K99673372-001-01-9
Brondilat (TN)
C07482
C35H36ClNO3S
cc-91
CCG-221186
CHEBI:50730
CHEBI:94710
CHEMBL787
Cyclopropaneacetic acid, 1-((((1R)-1-(3-((1E)-2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)-
Cyclopropaneacetic acid, 1-(((1-(3-(2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)-, (R-(E))-
Cyclopropaneaceticacid,1-[[[(1R)-1-[3-[(1E)-2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]-
D08229
DB00471
DTXSID9023334
GTPL3340
HMS2089D07
HMS3715N13
HSDB 7582
LS-173539
MHM278SD3E
MK 0476
MolPort-006-167-557
montelukast
Montelukast (INN)
Montelukast [INN:BAN]
Montelukastum
NCGC00188977-01
r-(e)-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid
SB19081
SC-80452
SCHEMBL4486
SCHEMBL4487
Singular
sodium 1-(((1-(3-(2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropylacetate
SR-01000763441
SR-01000763441-3
SR-01000763441-5
UCHDWCPVSPXUMX-TZIWLTJVSA-N
UNII-MHM278SD3E
ZINC3831151

US Patents and Regulatory Information for SINGULAIR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck SINGULAIR montelukast sodium GRANULE;ORAL 021409-001 Jul 26, 2002 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Msd Merck Co SINGULAIR montelukast sodium TABLET;ORAL 020829-002 Feb 20, 1998 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-002 Mar 3, 2000 AB RX Yes No   Start Trial   Start Trial   Start Trial
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-001 Feb 20, 1998 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for SINGULAIR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck SINGULAIR montelukast sodium GRANULE;ORAL 021409-001 Jul 26, 2002   Start Trial   Start Trial
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-001 Feb 20, 1998   Start Trial   Start Trial
Msd Merck Co SINGULAIR montelukast sodium TABLET;ORAL 020829-002 Feb 20, 1998   Start Trial   Start Trial
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-002 Mar 3, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for SINGULAIR
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 10 mg ➤ Subscribe   Start Trial
➤ Subscribe Chewable Tablets 4 mg and 5 mg ➤ Subscribe   Start Trial

Supplementary Protection Certificates for SINGULAIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0480717 C990009 Netherlands   Start Trial PRODUCT NAME: MONTELUKASTUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER NATRII MONTELUKASTUM; NATL REGISTRATION NO/DATE: RVG 23164 AND RVG 23165 19981103; FIRST REGISTRATION: FI 12766 AND 12767 19970825
0480717 98C0022 France   Start Trial PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
0480717 19/1999 Austria   Start Trial PRODUCT NAME: MONTELUKAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE MONTELUKASTNATRIUM; NAT. REGISTRATION NO/DATE: 1-22765 UND 1-22766 19981030; FIRST REGISTRATION: FI 12766 UND 12767 19970825
0480717 9890027-7 Sweden   Start Trial PRODUCT NAME: MONTELUKAST, R-(E)-1-1-3-2-(7-KLOR-2KINOLINYL)-ETENYL)-FENYL)-3-(2-(1-HYDROXI-1-METYLETYL)-FENYL)-PROPYL)-TIO)METYL)-CYKLOPROPANAETTIKSYRA, ELLER ETT FARMACEUTISKT GODDTAGBART SALT DAERAV, FOERETRAEDESVIS NATRIUMSALTET; NAT REG./DATE: 13944 19880111; FIRST REG.: FI EG 12766 19970825
0480717 SPC/GB98/025 United Kingdom   Start Trial PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Medtronic
Baxter
Johnson and Johnson
McKinsey
Moodys

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