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Generated: December 11, 2018

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SINGULAIR Drug Profile

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Which patents cover Singulair, and when can generic versions of Singulair launch?

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. Fifty-seven suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.

Drug patent expirations by year for SINGULAIR
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
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
Apxi toxin
BDBM50052024
BIDD:GT0394
BRD-K99673372-001-01-9
Brondilat
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]-
D00QET
D08229
DB00471
DTXSID9023334
GTPL3340
HE072072
HE315307
HMS2089D07
HSDB 7582
LS-173539
MHM278SD3E
MK 0476
MK-0476
MolPort-006-167-557
Montair
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
SC-80452
SCHEMBL4486
SCHEMBL4487
Singulair (TN)
Singular
sodium 1-(((1-(3-(2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropylacetate
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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Msd Merck Co SINGULAIR montelukast sodium TABLET;ORAL 020829-002 Feb 20, 1998 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-002 Mar 3, 2000 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-001 Feb 20, 1998 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Try a Free Trial ➤ Try a Free Trial
Msd Merck Co SINGULAIR montelukast sodium TABLET;ORAL 020829-002 Feb 20, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-001 Feb 20, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-002 Mar 3, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for SINGULAIR
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 10 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Chewable Tablets 4 mg and 5 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for SINGULAIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90009 Netherlands ➤ Try a Free 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
/1999 Austria ➤ Try a Free 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
90027-7 Sweden ➤ Try a Free 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
C/GB98/025 United Kingdom ➤ Try a Free 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
C0022 France ➤ Try a Free Trial PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

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Healthtrust
Chubb
McKesson
Fuji
US Army
Fish and Richardson
Cipla

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