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Last Updated: December 6, 2019

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Montelukast sodium - Generic Drug Details

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What are the generic drug sources for montelukast sodium and what is the scope of freedom to operate?

Montelukast sodium is the generic ingredient in two branded drugs marketed by Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Mylan Pharms Inc, Teva Pharms, Torrent, Merck, Anbison Lab, Apotex Inc, Aurobindo Pharma Ltd, Cipla, Cspc Ouyi, Hetero Labs Ltd V, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Sandoz Inc, Torrent Pharms Ltd, Unichem Labs Ltd, Unimark Remedies Ltd, Vintage Pharms Llc, West-ward Pharms Int, Msd Merck Co, Accord Hlthcare, Amneal Pharms, Apotex Corp, Glenmark Generics, and L Perrigo Co, and is included in forty-nine NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Montelukast sodium has twenty-eight patent family members in twenty-five countries.

There are thirty-five drug master file entries for montelukast sodium. Forty-six suppliers are listed for this compound.

Drug Sales Revenue Trends for montelukast sodium

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Recent Clinical Trials for montelukast sodium

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

SponsorPhase
Merck Sharp & Dohme Corp.Phase 2
Beijing Chao Yang HospitalPhase 4
GlaxoSmithKlinePhase 1

See all montelukast sodium clinical trials

Recent Litigation for montelukast sodium

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 montelukast sodium litigation

Pharmacology for montelukast sodium
Synonyms for montelukast sodium
1-((((1R)-1-(3-((1E)-2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetic acid monosodium salt
1-[[[(1R)-1-[3-[(1E)-2-(7-Chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid sodium salt
1-[[[(R)-1-[3-[2-(7-Chloro-2-quinolyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]-1-cyclopropaneacetic acid sodium salt
1-[1-[[[(1R)-1-[3-[(1E)-2-(7-Chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic Acid Sodium Salt
151767-02-1
158966-92-8 (Parent)
176636-EP2287154A1
2-[1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]thio]methyl]cyclopropyl]acetate; sodium
ACN-052465
ACT06295
AKOS015833416
AKOS015994699
AKOS032949734
AM62787
AMX10104
AN-380
AOB6098
BC201069
BCP9000959
C35H35ClNO3S.Na
CAS-151767-02-1
CCG-101049
CHEBI:6993
CHEMBL1200681
CM0155
CPD000469188
CS-0548
CYC099
Cyclopropaneacetic acid, 1-((((1R)-1-(3-((1E)-2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)-, monosodium salt
Cyclopropaneacetic acid, 1-(((1-(3-(2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)-, sodium salt, (R-(E))-
Cyclopropaneacetic acid, 1-[[[(1R)-1-[3-[(1E)-2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]-, sodium salt (1:1)
Cyclopropaneacetic acid,1-[[[(1R)-1-[3-[(1E)-2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]-,sodium salt
D00529
DSSTox_CID_26450
DSSTox_GSID_46450
DSSTox_RID_81624
DTXSID8046450
FT-0082752
HMS2051F18
HMS2235H19
HY-13315
J-008841
J-522711
KB-19271
Kipres
Kokast
KS-1087
L-706631
LBFBRXGCXUHRJY-HKHDRNBDSA-M
LS-173407
Lukasm
M2340
MK 0476
MK 476
MK-0476
MK-476
MK-476, Singulair
MLS001304727
MLS001424198
MolPort-002-885-842
Montair
Montelukast (sodium)
MONTELUKAST Na
Montelukast sodium (JP17/USAN)
Montelukast sodium [USAN]
Montelukast sodium salt
Montelukast sodium, 98%
NC00299
NCGC00164568-01
NCGC00164568-04
RL01936
s4211
SAM001246657
SCHEMBL9414
SCHEMBL9415
Singulair
Singulair (TN)
Singular
SMR000469188
sodium (R,E)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetate
sodium {1-[({(1R)-1-{3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl}-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl}sulfanyl)methyl]cyclopropyl}acetate
Sodium 1-((((R)-m -((E)-2-(7-chloro-2-quinolyl)vinyl)-alpha-(o-(1-hydroxy-1-methylethyl)phenethyl)benzyl)thio)methyl)cyclopropaneacetate
Sodium 1-((((R)-m-((E)-2-(7-chloro-2-quinolyl)vinyl)-alpha-(o-(1-hydroxy-1-methylethyl)phenethyl)benzyl)thio)methyl)cyclopropaneacetate
sodium 1-[[[(1R)-1-[3-[(1E)-2-(7-chloroquinoline-2-yl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetate
sodium 2-(1-((((R)-1-(3-((E)-2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propyl)sulfanyl)methyl)cyclopropyl)acetate
sodium 2-[1-[[(1R)-1-[3-[(E)-2-(7-chloro-2-quinolyl)vinyl]phenyl]-3-[2-(1-hydroxy-1-methyl-ethyl)phenyl]propyl]sulfanylmethyl]cyclopropyl]acetate
sodium;2-[1-[[(1R)-1-[3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanylmethyl]cyclopropyl]acetate
SW197679-2
Tox21_112197
Tox21_112197_1
U1O3J18SFL
UNII-U1O3J18SFL
Paragraph IV (Patent) Challenges for MONTELUKAST SODIUM
Tradename Dosage Ingredient NDA Submissiondate
SINGULAIR GRANULE;ORAL montelukast sodium 021409 2008-10-17
SINGULAIR TABLET;ORAL montelukast sodium 020829 2007-02-20
SINGULAIR TABLET, CHEWABLE;ORAL montelukast sodium 020830 2006-12-26

US Patents and Regulatory Information for montelukast sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 201581-001 Aug 6, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Cspc Ouyi MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 209011-001 Apr 18, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 079103-001 Aug 3, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
Teva Pharms MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 078723-002 Aug 3, 2012 AB RX No 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
Hetero Labs Ltd V MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 204093-001 May 22, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 079142-001 Aug 3, 2012 DISCN No No   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 montelukast sodium

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;ORAL 020829-002 Feb 20, 1998   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, CHEWABLE;ORAL 020830-002 Mar 3, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for montelukast sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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
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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Colorcon
Baxter
Dow

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