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Montelukast Sodium Patent Expiration

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. 30 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.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Singulair US8007830 Granule formation Oct 24, 2022

(Expired)

 Organon
Singulair US5565473

(Pediatric)

 Unsaturated hydroxyalkylquinoline acids as leukotriene antagonists Aug 03, 2012

(Expired)

 Organon



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.

Given below is the list recent legal activities going on the following patents of Montelukast Sodium.

Activity Date Patent Number
Patent litigations
Expire Patent
Critical
 02 Oct, 2023 US8007830
Maintenance Fee Reminder Mailed
Critical
 19 Apr, 2023 US8007830
Payment of Maintenance Fee, 8th Year, Large Entity 16 Jan, 2019 US8007830
Recordation of Patent Grant Mailed
Critical
 30 Aug, 2011 US8007830
Patent Issue Date Used in PTA Calculation
Critical
 30 Aug, 2011 US8007830
Issue Notification Mailed
Critical
 10 Aug, 2011 US8007830
Application Is Considered Ready for Issue
Critical
 26 Jul, 2011 US8007830
Dispatch to FDC 26 Jul, 2011 US8007830
Issue Fee Payment Received
Critical
 25 Jul, 2011 US8007830
Issue Fee Payment Verified
Critical
 25 Jul, 2011 US8007830


Montelukast Sodium's Family Patents

Family Patents

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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.
Toronto Apotex Inc.
Richmond Hill 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
Berlin Breckenridge Pharmaceutical, Inc
Boca Raton 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
Pithampur, District Dhar Cipla Limited
Bangalore Cipla Ltd.
Mumbai Cipla Limited
Bengaluru Cipla Limited
Vasco Da Gama Cipla Limited
Raigad Cipla Limited
Kurkumbh Village, Dist. Pune Cipla, Ltd.





11. DR REDDYS LABS LTD

Dr Reddys Laboratories 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 Dr Reddys Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
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
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Cherry Hill Hikma Pharmaceuticals USA Inc.
Dayton Hikma Injectables USA Inc
Eatontown Hikma Pharmaceuticals USA, Inc.
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
Rangareddy NATCO Pharma Limited
Chennai NATCO Pharma Limited Chemical Division Chennai
Hyderabad Natco Pharma Limited
Paravada Natco Pharma Limited
Hyderabad NATCO PHARMA LTD
Rangareddy District Natco Pharma Ltd. - Chemical Division





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)
Saddle Brook Rising Pharmaceuticals, Inc.
Rising Sun Rising Sun Veterinary Clinic
Mount Morris Rising Creek Bakery LLC
East Brunswick Rising Pharma Holding, Inc.
Decatur Rising Pharma Holdings, Inc
Livingston Risingsun Iodine Products Corp.
Phoenix Rising Sun Farms Inc
Fort Bragg Rising Tide Sea Vegetables
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. SENORES PHARMS

Senores Pharmaceuticals 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 Senores Pharms.

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





24. 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





25. 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





26. 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
Gandhi Nagar Torrent Pharmaceuticals Limited
Indrad Torrent Pharmaceuticals Limited
Pithampur Torrent Pharmaceuticals Limited
Bharuch Torrent Pharmaceuticals Limited
Thanam Torrent Pharmaceuticals Limited
United States
Basking Ridge Torrent Pharma Inc.
Kalamazoo Torrent Pharma Inc.





27. 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





28. 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
Ghaziabad Unichem Laboratories Ltd.
Pilerne Bardez Unichem Laboratories Limited
District Raigad Unichem Laboratories Ltd
Kolhapur Unichem Laboratories Limited
Pithampur Unichem Laboratories Limited
Mumbai Unichem Laboratories Limited
United States
East Brunswick Unichem Pharmaceuticals USA Inc.
Hasbrouck Heights Unichem Pharmaceuticals Usa Inc





29. 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.

Country City Firm Name
India
Kerala Unimark Remedies Ltd.