Montelukast Sodium Patent Expiration
Montelukast Sodium is Used for treating Asthma It was first introduced by Organon Llc A Sub Of Organon And Co
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 |
US5565473 (Pediatric) | Unsaturated hydroxyalkylquinoline acids as leukotriene antagonists |
Aug 03, 2012
(Expired) | Organon |
| Singulair | US8007830 | Granule formation |
Oct 24, 2022
(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.
Latest Legal Activities on Montelukast Sodium's Patents
Given below is the list recent legal activities going on the following patents of Montelukast Sodium.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Expire Patent | 02 Oct, 2023 | US8007830 |
| Maintenance Fee Reminder Mailed | 19 Apr, 2023 | US8007830 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Jan, 2019 | US8007830 |
| Recordation of Patent Grant Mailed | 30 Aug, 2011 | US8007830 |
| Patent Issue Date Used in PTA Calculation | 30 Aug, 2011 | US8007830 |
| Issue Notification Mailed | 10 Aug, 2011 | US8007830 |
| Application Is Considered Ready for Issue | 26 Jul, 2011 | US8007830 |
| Dispatch to FDC | 26 Jul, 2011 | US8007830 |
| Issue Fee Payment Received | 25 Jul, 2011 | US8007830 |
| Issue Fee Payment Verified | 25 Jul, 2011 | US8007830 |
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Montelukast Sodium Generics
Several generic applications have been filed for Montelukast Sodium. The first generic version for Montelukast Sodium was by Mylan Pharmaceuticals Inc 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.
1. GRAVITI PHARMS
Graviti Pharmaceuticals Inc has filed for 1 generic for Montelukast Sodium. Given below are the details of the strengths of this generic introduced by Graviti Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 10MG BASE | tablet | Prescription | ORAL | AB | Apr 24, 2017 |
2. 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 |
3. 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 |
4. 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 |
5. 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 |
6. 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 |
7. 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 |
8. 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 |
9. 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 |
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 |
11. 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 |
12. 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 |
13. 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 |
14. 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 |
15. 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 |
16. 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 |
17. 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 |
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. 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 |
20. MYLAN PHARMS INC
Mylan Pharmaceuticals Inc 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 Mylan Pharms Inc.
| 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 |
| EQ 4MG BASE/PACKET | granule | Discontinued | ORAL | N/A | Dec 18, 2012 |
21. 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 | Prescription | ORAL | AB | Aug 3, 2012 |
| EQ 10MG BASE | tablet | Prescription | ORAL | AB | Aug 3, 2012 |
| EQ 5MG BASE | tablet, chewable | Prescription | ORAL | AB | Aug 3, 2012 |
22. RISING
Rising Pharma Holdings 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 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 |
23. 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 |
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. 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 |
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. 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 |
28. 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 |