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Generated: June 19, 2018

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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 montelukast sodium 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, Merck, Anbison Lab Co Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Hetero Labs Ltd V, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Sandoz Inc, Torrent Pharms Ltd, Unimark Remedies Ltd, Vintage Pharms Llc, West-ward Pharms Int, Msd Merck Co, Accord Hlthcare, Amneal Pharms, Apotex Corp, Cipla Ltd, Glenmark Generics, Perrigo R And D, and Unichem Labs Ltd, and is included in forty-six 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-four drug master file entries for montelukast sodium. Fifty-nine suppliers are listed for this compound.
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
ACN-052465
ACT06295
AK326869
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
HE313711
HMS2051F18
HMS2235H19
HY-13315
J-008841
J-522711
KB-19271
Kipres
Kokast
KS-1087
L-706631
LBFBRXGCXUHRJY-HKHDRNBDSA-M
LS-173407
Lukasm
M2340
MFCD00931431
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
NC00299
NCGC00164568-01
NCGC00164568-04
RL01936
s4211
SAM001246657
SCHEMBL9414
SCHEMBL9415
Singulair
Singulair (TN)
SMR000469188
sodium (R,E)-2-(1-(((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propyl)thio)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
Tox21_112197
Tox21_112197_1
U1O3J18SFL
UNII-U1O3J18SFL

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
Cspc Ouyi Pharm Co MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 209011-002 Apr 18, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vintage Pharms Llc MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 091588-001 Aug 3, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Accord Hlthcare MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 202717-001 Sep 21, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sandoz Inc MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 200889-001 Aug 3, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 montelukast sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Merck Co SINGULAIR montelukast sodium TABLET;ORAL 020829-002 Feb 20, 1998 ➤ Sign Up ➤ Sign Up
Merck SINGULAIR montelukast sodium GRANULE;ORAL 021409-001 Jul 26, 2002 ➤ Sign Up ➤ Sign Up
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-001 Feb 20, 1998 ➤ Sign Up ➤ Sign Up
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-002 Mar 3, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for montelukast sodium

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0022 France ➤ Sign Up PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
90009 Netherlands ➤ Sign Up 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
90027-7 Sweden ➤ Sign Up 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
/1999 Austria ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Colorcon
Cipla
UBS
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Julphar
Mallinckrodt
Argus Health
Cerilliant

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