Montelukast Sodium is Used for treating Asthma It was first introduced by Organon Llc A Sub Of Organon And Co in its drug Singulair on Feb 20, 1998. 29 different companies have introduced drugs containing Montelukast Sodium.
Montelukast Sodium Patents
Given below is the list of patents protecting Montelukast Sodium, along
with the drug name that holds that patent and the company name owning that
drug.
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Montelukast Sodium's patents.
Latest Legal Activities on Montelukast Sodium's Patents
Given below is the list recent legal activities going on the following patents of Montelukast Sodium.
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Montelukast Sodium Generic API Manufacturers
Several generic applications have been filed for Montelukast Sodium. The first generic version for Montelukast Sodium was by Norvium Bioscience Llc and was approved on Aug 3, 2012. And the latest generic version is by Breckenridge Pharmaceutical Inc and was approved on Oct 30, 2020.
Given below is the list of companies who have filed for
Montelukast Sodium generic, along with the locations of their manufacturing plants worldwide.
1. ACCORD HLTHCARE
Accord Healthcare Inc has filed for 1 generic for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Accord Hlthcare.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 10MG BASE
tablet
Prescription
ORAL
AB
Sep 21, 2012
2. AJANTA PHARMA LTD
Ajanta Pharma Ltd has filed for 4 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Ajanta Pharma Ltd.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 10MG BASE
tablet
Discontinued
ORAL
N/A
Jul 31, 2015
EQ 5MG BASE
tablet, chewable
Discontinued
ORAL
N/A
Jul 31, 2015
EQ 4MG BASE
tablet, chewable
Discontinued
ORAL
N/A
Jul 31, 2015
EQ 4MG BASE/PACKET
granule
Prescription
ORAL
AB
Jul 31, 2015
Manufacturing Plant Locations
New
Ajanta Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Ajanta Pharma Ltd as present at those locations.
Country
City
Firm Name
India
Aurangabad
Ajanta Pharma Ltd.
3. AMNEAL PHARMS
Amneal Pharmaceuticals Of New York Llc has filed for 3 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Amneal Pharms.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 10MG BASE
tablet
Prescription
ORAL
AB
Sep 4, 2015
EQ 5MG BASE
tablet, chewable
Prescription
ORAL
AB
Sep 4, 2020
EQ 4MG BASE
tablet, chewable
Prescription
ORAL
AB
Sep 4, 2020
4. ANBISON LAB
Anbison Laboratory Co Ltd has filed for 3 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Anbison Lab.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 5MG BASE
tablet, chewable
Prescription
ORAL
AB
Nov 5, 2015
EQ 4MG BASE
tablet, chewable
Prescription
ORAL
AB
Nov 5, 2015
EQ 10MG BASE
tablet
Prescription
ORAL
AB
Jan 12, 2016
5. APOTEX CORP
Apotex Corp has filed for 1 generic for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Apotex Corp.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 10MG BASE
tablet
Discontinued
ORAL
N/A
Aug 3, 2012
Manufacturing Plant Locations
New
Apotex Corp's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Apotex Corp as present at those locations.
Country
City
Firm Name
United States
Weston
Apotex Corp.
6. APOTEX INC
Apotex Inc has filed for 2 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Apotex Inc.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 4MG BASE
tablet, chewable
Discontinued
ORAL
N/A
Aug 3, 2012
EQ 5MG BASE
tablet, chewable
Discontinued
ORAL
N/A
Aug 3, 2012
Manufacturing Plant Locations
New
Apotex Inc's manufacturing plants are situated in 1 country - Canada. Given below are the details of these plant locations as well as the firm names of Apotex Inc as present at those locations.
Country
City
Firm Name
Canada
North York
Apotex Inc.
Richmond Hill
Apotex Inc.
Toronto
Apotex Inc.
7. AUROBINDO PHARMA LTD
Aurobindo Pharma Ltd has filed for 4 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Aurobindo Pharma Ltd.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 4MG BASE
tablet, chewable
Prescription
ORAL
AB
Aug 3, 2012
EQ 5MG BASE
tablet, chewable
Prescription
ORAL
AB
Aug 3, 2012
EQ 10MG BASE
tablet
Prescription
ORAL
AB
Aug 3, 2012
EQ 4MG BASE/PACKET
granule
Prescription
ORAL
AB
Feb 18, 2020
Manufacturing Plant Locations
New
Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.
Country
City
Firm Name
India
Medchal
Aurobindo Pharma Ltd
8. BRECKENRIDGE
Breckenridge Pharmaceutical Inc has filed for 1 generic for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Breckenridge.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 10MG BASE
tablet
Discontinued
ORAL
N/A
Oct 30, 2020
Manufacturing Plant Locations
New
Breckenridge's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Breckenridge as present at those locations.
Country
City
Firm Name
United States
Boca Raton
Breckenridge Pharmaceutical, Inc.
Berlin
Breckenridge Pharmaceutical, Inc
9. CHARTWELL MOLECULAR
Chartwell Molecular Holdings Llc has filed for 3 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Chartwell Molecular.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 10MG BASE
tablet
Prescription
ORAL
AB
Aug 3, 2012
EQ 4MG BASE
tablet, chewable
Prescription
ORAL
AB
Dec 6, 2018
EQ 5MG BASE
tablet, chewable
Prescription
ORAL
AB
Dec 6, 2018
10. CIPLA
Cipla Ltd has filed for 1 generic for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Cipla.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 10MG BASE
tablet
Prescription
ORAL
AB
Oct 28, 2016
Manufacturing Plant Locations
New
Cipla's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Cipla as present at those locations.
Country
City
Firm Name
India
Bengaluru
Cipla Limited
Bangalore
Cipla Ltd.
Vasco Da Gama
Cipla Limited
Pithampur, District Dhar
Cipla Limited
Mumbai
Cipla Limited
Raigad
Cipla Limited
Kurkumbh Village, Dist. Pune
Cipla, Ltd.
11. DR REDDYS LABS LTD
Dr Reddys Laboratories Ltd has filed for 4 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Dr Reddys Labs Ltd.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 4MG BASE
tablet, chewable
Prescription
ORAL
AB
Aug 6, 2012
EQ 5MG BASE
tablet, chewable
Prescription
ORAL
AB
Aug 6, 2012
EQ 10MG BASE
tablet
Prescription
ORAL
AB
Aug 6, 2012
EQ 4MG BASE/PACKET
granule
Prescription
ORAL
AB
Sep 17, 2012
12. GLENMARK PHARMS LTD
Glenmark Pharmaceuticals Ltd has filed for 1 generic for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Glenmark Pharms Ltd.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 10MG BASE
tablet
Prescription
ORAL
AB
Aug 3, 2012
13. HETERO LABS LTD V
Hetero Labs Ltd Unit V has filed for 3 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Hetero Labs Ltd V.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 10MG BASE
tablet
Prescription
ORAL
AB
Sep 10, 2014
EQ 5MG BASE
tablet, chewable
Prescription
ORAL
AB
May 22, 2015
EQ 4MG BASE
tablet, chewable
Prescription
ORAL
AB
May 22, 2015
14. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Hikma.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 10MG BASE
tablet
Discontinued
ORAL
N/A
Aug 3, 2012
EQ 4MG BASE
tablet, chewable
Discontinued
ORAL
N/A
Aug 3, 2012
EQ 5MG BASE
tablet, chewable
Discontinued
ORAL
N/A
Aug 3, 2012
Manufacturing Plant Locations
New
Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.
Country
City
Firm Name
United States
Eatontown
Hikma Pharmaceuticals USA, Inc.
Cherry Hill
Hikma Pharmaceuticals USA Inc.
Dayton
Hikma Injectables USA Inc
Carlsbad
Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Portugal
Terrugem Snt
Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman
Hikma Pharmaceuticals LLC
15. JUBILANT GENERICS
Jubilant Generics Ltd has filed for 2 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Jubilant Generics.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 5MG BASE
tablet, chewable
Discontinued
ORAL
N/A
Feb 27, 2015
EQ 4MG BASE
tablet, chewable
Discontinued
ORAL
N/A
Feb 27, 2015
Manufacturing Plant Locations
New
Jubilant Generics's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Jubilant Generics as present at those locations.
Country
City
Firm Name
India
Roorkee
Jubilant Generics Limited
16. L PERRIGO CO
L Perrigo Co has filed for 1 generic for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
L Perrigo Co.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 10MG BASE
tablet
Discontinued
ORAL
N/A
Apr 26, 2017
17. LANNETT CO INC
Lannett Co Inc has filed for 2 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Lannett Co Inc.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 4MG BASE
tablet, chewable
Prescription
ORAL
AB
Aug 3, 2012
EQ 5MG BASE
tablet, chewable
Prescription
ORAL
AB
Aug 3, 2012
18. MACLEODS PHARMS LTD
Macleods Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Macleods Pharms Ltd.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 10MG BASE
tablet
Prescription
ORAL
AB
Sep 11, 2014
EQ 5MG BASE
tablet, chewable
Prescription
ORAL
AB
Mar 12, 2015
EQ 4MG BASE
tablet, chewable
Prescription
ORAL
AB
Mar 12, 2015
19. NATCO PHARMA
Natco Pharma Ltd has filed for 2 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Natco Pharma.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 4MG BASE
tablet, chewable
Discontinued
ORAL
N/A
Aug 3, 2012
EQ 5MG BASE
tablet, chewable
Discontinued
ORAL
N/A
Aug 3, 2012
Manufacturing Plant Locations
New
Natco Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Natco Pharma as present at those locations.
Country
City
Firm Name
India
Hyderabad
NATCO PHARMA LTD
Paravada
Natco Pharma Limited
Hyderabad
Natco Pharma Limited
Chennai
NATCO Pharma Limited Chemical Division Chennai
Rangareddy District
Natco Pharma Ltd. - Chemical Division
Rangareddy
NATCO Pharma Limited
20. NORVIUM BIOSCIENCE
Norvium Bioscience Llc has filed for 2 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Norvium Bioscience.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 10MG BASE
tablet
Discontinued
ORAL
N/A
Aug 3, 2012
EQ 4MG BASE/PACKET
granule
Discontinued
ORAL
N/A
Dec 18, 2012
21. RISING
Rising Pharma Holdings Inc has filed for 3 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Rising.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 5MG BASE
tablet, chewable
Prescription
ORAL
AB
Apr 18, 2017
EQ 4MG BASE
tablet, chewable
Prescription
ORAL
AB
Apr 18, 2017
EQ 10MG BASE
tablet
Prescription
ORAL
AB
Apr 24, 2017
Manufacturing Plant Locations
New
Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.
Country
City
Firm Name
United States
Flagstaff
Rising High Enterprises, LLC (DBA RisingHy)
Rising Sun
Rising Sun Veterinary Clinic
Fort Bragg
Rising Tide Sea Vegetables
Mount Morris
Rising Creek Bakery LLC
Decatur
Rising Pharma Holdings, Inc
Saddle Brook
Rising Pharmaceuticals, Inc.
East Brunswick
Rising Pharma Holding, Inc.
Livingston
Risingsun Iodine Products Corp.
Phoenix
Rising Sun Farms Inc
Mexico
Pueblo San Clemente
RISING FARMS SAPI DE CV
India
Ahmedabad
Rising Retina Clinic
22. SANDOZ INC
Sandoz Inc has filed for 3 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Sandoz Inc.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 4MG BASE
tablet, chewable
Discontinued
ORAL
N/A
Aug 3, 2012
EQ 10MG BASE
tablet
Discontinued
ORAL
N/A
Aug 3, 2012
EQ 5MG BASE
tablet, chewable
Discontinued
ORAL
N/A
Aug 3, 2012
Manufacturing Plant Locations
New
Sandoz Inc's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Sandoz Inc as present at those locations.
Country
City
Firm Name
United States
Princeton
Sandoz Inc
East Hanover
Sandoz Incorporated
23. STRIDES PHARMA
Strides Pharma Global Pte Ltd has filed for 3 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Strides Pharma.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 10MG BASE
tablet
Discontinued
ORAL
N/A
Aug 3, 2012
EQ 4MG BASE
tablet, chewable
Discontinued
ORAL
N/A
Aug 3, 2012
EQ 5MG BASE
tablet, chewable
Discontinued
ORAL
N/A
Aug 3, 2012
Manufacturing Plant Locations
New
Strides Pharma's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Strides Pharma as present at those locations.
Country
City
Firm Name
United States
East Brunswick
Strides Pharma Inc.
Chestnut Ridge
Strides Pharma, Inc.
India
Bangalore
Strides Pharma Science Limited
Puducherry
Strides Pharma Science Limited
24. TEVA PHARMS
Teva Pharmaceuticals Usa has filed for 4 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Teva Pharms.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 4MG BASE/PACKET
granule
Discontinued
ORAL
N/A
Aug 3, 2012
EQ 10MG BASE
tablet
Prescription
ORAL
AB
Aug 3, 2012
EQ 4MG BASE
tablet, chewable
Prescription
ORAL
AB
Aug 3, 2012
EQ 5MG BASE
tablet, chewable
Prescription
ORAL
AB
Aug 3, 2012
25. TORRENT
Torrent Pharmaceuticals Ltd has filed for 1 generic for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Torrent.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 4MG BASE/PACKET
granule
Prescription
ORAL
AB
Jul 31, 2018
Manufacturing Plant Locations
New
Torrent's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Torrent as present at those locations.
Country
City
Firm Name
India
Bharuch
Torrent Pharmaceuticals Limited
Pithampur
Torrent Pharmaceuticals Limited
Indrad
Torrent Pharmaceuticals Limited
Gandhi Nagar
Torrent Pharmaceuticals Limited
Thanam
Torrent Pharmaceuticals Limited
United States
Kalamazoo
Torrent Pharma Inc.
Basking Ridge
Torrent Pharma Inc.
26. TORRENT PHARMS LTD
Torrent Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Torrent Pharms Ltd.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 4MG BASE
tablet, chewable
Prescription
ORAL
AB
Aug 3, 2012
EQ 5MG BASE
tablet, chewable
Prescription
ORAL
AB
Aug 3, 2012
EQ 10MG BASE
tablet
Prescription
ORAL
AB
Aug 3, 2012
27. UNICHEM
Unichem Laboratories Ltd has filed for 3 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Unichem.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 10MG BASE
tablet
Prescription
ORAL
AB
Oct 8, 2015
EQ 4MG BASE
tablet, chewable
Discontinued
ORAL
N/A
Jul 2, 2018
EQ 5MG BASE
tablet, chewable
Discontinued
ORAL
N/A
Jul 2, 2018
Manufacturing Plant Locations
New
Unichem's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Unichem as present at those locations.
Country
City
Firm Name
India
Pilerne Bardez
Unichem Laboratories Limited
District Raigad
Unichem Laboratories Ltd
Ghaziabad
Unichem Laboratories Ltd.
Kolhapur
Unichem Laboratories Limited
Mumbai
Unichem Laboratories Limited
Pithampur
Unichem Laboratories Limited
United States
East Brunswick
Unichem Pharmaceuticals USA Inc.
Hasbrouck Heights
Unichem Pharmaceuticals Usa Inc
28. UNIMARK REMEDIES LTD
Unimark Remedies Ltd has filed for 3 different strengths of generic version for Montelukast Sodium. Given below are the
details of the strengths of this generic introduced by
Unimark Remedies Ltd.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 5MG BASE
tablet, chewable
Prescription
ORAL
AB
Oct 30, 2014
EQ 10MG BASE
tablet
Prescription
ORAL
AB
Oct 30, 2014
EQ 4MG BASE
tablet, chewable
Prescription
ORAL
AB
Oct 30, 2014
Manufacturing Plant Locations
New
Unimark Remedies Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Unimark Remedies Ltd as present at those locations.
