Methotrexate Sodium Patent Expiration
Methotrexate Sodium is Used for treating acute lymphoblastic leukemia and juvenile rheumatoid arthritis. It was first introduced by Strides Pharma Global Pte Ltd
Methotrexate Sodium Patents
Given below is the list of patents protecting Methotrexate 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 |
|---|---|---|---|---|
| Xatmep | US10231927 | Methotrexate composition | Jan 02, 2033 | Azurity |
| Xatmep | US10610485 | Methotrexate composition | Jan 02, 2033 | Azurity |
| Xatmep | US11116724 | Methotrexate composition | Jan 02, 2033 | Azurity |
| Xatmep | US11969503 | Methotrexate composition | Jan 02, 2033 | Azurity |
| Xatmep | US9259427 | Methotrexate composition | Jan 02, 2033 | Azurity |
| Xatmep | US9855215 | Methotrexate composition | Jan 02, 2033 | Azurity |
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 Methotrexate Sodium's patents.
Latest Legal Activities on Methotrexate Sodium's Patents
Given below is the list recent legal activities going on the following patents of Methotrexate Sodium.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Sep, 2023 | US10610485 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 05 Aug, 2022 | US10231927 |
| Patent Issue Date Used in PTA Calculation | 14 Sep, 2021 | US11116724 |
| Recordation of Patent Grant Mailed | 14 Sep, 2021 | US11116724 |
| Email Notification | 26 Aug, 2021 | US11116724 |
| Issue Notification Mailed | 25 Aug, 2021 | US11116724 |
| Dispatch to FDC | 16 Aug, 2021 | US11116724 |
| Application Is Considered Ready for Issue | 16 Aug, 2021 | US11116724 |
| Issue Fee Payment Received | 10 Aug, 2021 | US11116724 |
| Issue Fee Payment Verified | 10 Aug, 2021 | US11116724 |
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Methotrexate Sodium Generics
Several generic applications have been filed for Methotrexate Sodium. The first generic version for Methotrexate Sodium was by Bristol Laboratories Inc Div Bristol Myers Co and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Alembic Pharmaceuticals Ltd and was approved on Jun 3, 2024.
Given below is the list of companies who have filed for Methotrexate Sodium generic.
1. LOTUS PHARM CO LTD
Lotus Pharmaceutical Co Ltd Nantou Plant has filed for 1 generic for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Lotus Pharm Co Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2.5MG BASE | tablet | Discontinued | ORAL | N/A | Apr 23, 2021 |
2. BARR
Barr Laboratories Inc has filed for 5 different strengths of generic version for Methotrexate Sodium. Out of these eq 7.5mg base version comes by the name TREXALL, eq 5mg base version comes by the name TREXALL, eq 10mg base version comes by the name TREXALL, eq 15mg base version comes by the name TREXALL. Given below are the details of the strengths of this generic introduced by Barr.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2.5MG BASE | tablet | Prescription | ORAL | AB | Oct 15, 1990 |
| EQ 7.5MG BASE | tablet | Prescription | ORAL | N/A | Mar 21, 2001 |
| EQ 5MG BASE | tablet | Prescription | ORAL | N/A | Mar 21, 2001 |
| EQ 10MG BASE | tablet | Prescription | ORAL | N/A | Mar 21, 2001 |
| EQ 15MG BASE
(reference standard) | tablet | Prescription | ORAL | N/A | Mar 21, 2001 |
3. DURAMED PHARMS BARR
Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc has filed for 1 generic for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Duramed Pharms Barr.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2.5MG BASE | tablet | Discontinued | ORAL | N/A | Jun 17, 1999 |
4. AMNEAL PHARMS
Amneal Pharmaceuticals Of New York Llc has filed for 1 generic for Methotrexate 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 2.5MG BASE | tablet | Prescription | ORAL | AB | Dec 22, 2017 |
5. EUGIA PHARMA
Eugia Pharma Specialities Ltd has filed for 1 generic for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Eugia Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2.5MG BASE | tablet | Prescription | ORAL | AB | Jan 30, 2020 |
6. EXTROVIS
Extrovis Ag has filed for 1 generic for Methotrexate Sodium. This eq 1gm base/40ml (eq 25mg base/ml) version comes by the name METHOTREXATE SODIUM PRESERVATIVE FREE. Given below are the details of the strengths of this generic introduced by Extrovis.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | injectable | Discontinued | INJECTION | N/A | Mar 29, 2012 |
7. ALEMBIC
Alembic Pharmaceuticals Ltd has filed for 1 generic for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Alembic.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2.5MG BASE | tablet | Prescription | ORAL | AB | Jun 3, 2024 |
8. ELITE LABS INC
Elite Laboratories Inc has filed for 1 generic for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Elite Labs Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2.5MG BASE | tablet | Prescription | ORAL | AB | May 16, 2024 |
9. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 6 different strengths of generic version for Methotrexate Sodium. Out of these eq 50mg base/2ml (eq 25mg base/ml) version comes by the name METHOTREXATE SODIUM PRESERVATIVE FREE, eq 250mg base/10ml (eq 25mg base/ml) version comes by the name METHOTREXATE SODIUM PRESERVATIVE FREE, eq 1gm base/vial version comes by the name METHOTREXATE SODIUM PRESERVATIVE FREE. 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 50MG BASE/2ML (EQ 25MG BASE/ML)
(reference standard) | injectable | Prescription | INJECTION | AP | Sep 16, 1986 |
| EQ 200MG BASE/8ML (EQ 25MG BASE/ML)
(reference standard) | injectable | Prescription | INJECTION | N/A | Sep 16, 1986 |
| EQ 250MG BASE/10ML (EQ 25MG BASE/ML) | injectable | Prescription | INJECTION | AP | Sep 16, 1986 |
| EQ 100MG BASE/4ML (EQ 25MG BASE/ML)
(reference standard) | injectable | Prescription | INJECTION | AP | Sep 16, 1986 |
| EQ 2.5MG BASE
(reference standard) | tablet | Prescription | ORAL | AB | Aug 1, 1994 |
| EQ 1GM BASE/VIAL
(reference standard) | injectable | Prescription | INJECTION | N/A | Aug 12, 2005 |
10. BRISTOL
Bristol Laboratories Inc Div Bristol Myers Co has filed for 4 different strengths of generic version for Methotrexate Sodium. All of these versions come by the name MEXATE. Given below are the details of the strengths of this generic introduced by Bristol.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 250MG BASE/VIAL
(reference listed drug) | injectable | Discontinued | INJECTION | N/A | Approved Prior to Jan 1, 1982 |
| EQ 100MG BASE/VIAL
(reference listed drug) | injectable | Discontinued | INJECTION | N/A | Approved Prior to Jan 1, 1982 |
| EQ 50MG BASE/VIAL
(reference listed drug) | injectable | Discontinued | INJECTION | N/A | Approved Prior to Jan 1, 1982 |
| EQ 20MG BASE/VIAL
(reference listed drug) | injectable | Discontinued | INJECTION | N/A | Approved Prior to Jan 1, 1982 |
11. PHARMACHEMIE USA
Pharmachemie Usa Inc has filed for 1 generic for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Pharmachemie Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 25MG BASE/ML | injectable | Discontinued | INJECTION | N/A | Jul 8, 1988 |
12. PHARMACHEMIE BV
Pharmachemie Bv has filed for 5 different strengths of generic version for Methotrexate Sodium. All of these versions come by the name METHOTREXATE SODIUM PRESERVATIVE FREE. Given below are the details of the strengths of this generic introduced by Pharmachemie Bv.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | injectable | Prescription | INJECTION | AP | Jan 11, 2010 |
| EQ 250MG BASE/10ML (EQ 25MG BASE/ML) | injectable | Prescription | INJECTION | AP | Jan 11, 2010 |
| EQ 250MG/10ML (EQ 25MG BASE/ML) | injectable | Prescription | INJECTION | AP | Jan 11, 2010 |
| EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | injectable | Prescription | INJECTION | AP | Jan 11, 2010 |
| EQ 100MG BASE/4ML (EQ 25MG BASE/ML) | injectable | Prescription | INJECTION | N/A | Feb 27, 2012 |
13. ABIC
Abic Ltd has filed for 4 different strengths of generic version for Methotrexate Sodium. All of these versions come by the name ABITREXATE. Given below are the details of the strengths of this generic introduced by Abic.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 25MG BASE/ML | injectable | Discontinued | INJECTION | N/A | Mar 10, 1987 |
| EQ 50MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Jul 17, 1987 |
| EQ 250MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Jul 17, 1987 |
| EQ 100MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Jul 17, 1987 |
14. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Zydus Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2.5MG BASE | tablet | Prescription | ORAL | AB | Jan 13, 2017 |
15. ACCORD HLTHCARE
Accord Healthcare Inc has filed for 4 different strengths of generic version for Methotrexate Sodium. Out of these eq 250mg base/10ml (eq 25mg base/ml) version comes by the name METHOTREXATE SODIUM PRESERVATIVE FREE, eq 50mg base/2ml (eq 25mg base/ml) version comes by the name METHOTREXATE SODIUM PRESERVATIVE FREE, eq 1gm base/40ml (eq 25mg base/ml) version comes by the name METHOTREXATE SODIUM PRESERVATIVE FREE. 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 250MG BASE/10ML (EQ 25MG BASE/ML)
(reference standard) | injectable | Prescription | INJECTION | AP | Apr 30, 2007 |
| EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
(reference standard) | injectable | Prescription | INJECTION | AP | Apr 30, 2007 |
| EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
(reference standard) | injectable | Prescription | INJECTION | AP | Apr 30, 2007 |
| EQ 2.5MG BASE | tablet | Prescription | ORAL | AB | Jan 24, 2020 |
16. DAITO
Daito Pharmaceutical Co Ltd has filed for 1 generic for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Daito.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2.5MG BASE | tablet | Prescription | ORAL | AB | Aug 7, 2023 |
17. EUGIA PHARMA SPECLTS
Eugia Pharma Specialities Ltd has filed for 4 different strengths of generic version for Methotrexate Sodium. All of these versions come by the name METHOTREXATE SODIUM PRESERVATIVE FREE. Given below are the details of the strengths of this generic introduced by Eugia Pharma Speclts.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | injectable | Discontinued | INJECTION | N/A | Mar 29, 2012 |
| EQ 100MG BASE/4ML (EQ 25MG BASE/ML) | injectable | Discontinued | INJECTION | N/A | Mar 29, 2012 |
| EQ 200MG BASE/8ML (EQ 25MG BASE/ML) | injectable | Discontinued | INJECTION | N/A | Mar 29, 2012 |
| EQ 250MG BASE/10ML (EQ 25MG BASE/ML) | injectable | Discontinued | INJECTION | N/A | Mar 29, 2012 |
18. PHARMACIA AND UPJOHN
Pharmacia And Upjohn Co has filed for 5 different strengths of generic version for Methotrexate Sodium. Out of these eq 25mg base/vial version comes by the name FOLEX, eq 100mg base/vial version comes by the name FOLEX, eq 50mg base/vial version comes by the name FOLEX, eq 250mg base/vial version comes by the name FOLEX, eq 25mg base/ml version comes by the name FOLEX PFS. Given below are the details of the strengths of this generic introduced by Pharmacia And Upjohn.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 25MG BASE/VIAL
(reference listed drug) | injectable | Discontinued | INJECTION | N/A | Apr 8, 1983 |
| EQ 100MG BASE/VIAL
(reference listed drug) | injectable | Discontinued | INJECTION | N/A | Apr 8, 1983 |
| EQ 50MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Apr 8, 1983 |
| EQ 250MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Oct 24, 1985 |
| EQ 25MG BASE/ML | injectable | Discontinued | INJECTION | N/A | Aug 23, 1991 |
19. SANDOZ
Sandoz Inc has filed for 3 different strengths of generic version for Methotrexate Sodium. All of these versions come by the name METHOTREXATE SODIUM PRESERVATIVE FREE. Given below are the details of the strengths of this generic introduced by Sandoz.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | injectable | Prescription | INJECTION | AP | Mar 31, 2009 |
| EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | injectable | Prescription | INJECTION | AP | Mar 31, 2009 |
| EQ 250MG BASE/10ML (EQ 25MG BASE/ML) | injectable | Prescription | INJECTION | AP | Mar 31, 2009 |
20. ABRAXIS PHARM
Abraxis Pharmaceutical Products has filed for 5 different strengths of generic version for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Abraxis Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 20MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Oct 11, 1985 |
| EQ 50MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Oct 11, 1985 |
| EQ 100MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Oct 11, 1985 |
| EQ 25MG BASE/ML | injectable | Discontinued | INJECTION | N/A | Jun 13, 1986 |
| EQ 2.5MG BASE/ML | injectable | Discontinued | INJECTION | N/A | Jun 13, 1986 |
21. FRESENIUS KABI USA
Fresenius Kabi Usa Llc has filed for 4 different strengths of generic version for Methotrexate Sodium. Out of these eq 25mg base/ml version comes by the name METHOTREXATE PRESERVATIVE FREE, eq 1gm base/vial version comes by the name METHOTREXATE PRESERVATIVE FREE. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
(reference standard) | injectable | Prescription | INJECTION | AP | Feb 26, 1999 |
| EQ 25MG BASE/ML | injectable | Discontinued | INJECTION | N/A | Feb 26, 1999 |
| EQ 250MG BASE/10ML (EQ 25MG BASE/ML) | injectable | Discontinued | INJECTION | N/A | Feb 26, 1999 |
| EQ 1GM BASE/VIAL | injectable | Prescription | INJECTION | AP | Feb 26, 1999 |
22. SAGENT PHARMS INC
Sagent Pharmaceuticals Inc has filed for 3 different strengths of generic version for Methotrexate Sodium. All of these versions come by the name METHOTREXATE SODIUM PRESERVATIVE FREE. Given below are the details of the strengths of this generic introduced by Sagent Pharms Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | injectable | Prescription | INJECTION | AP | Aug 9, 2018 |
| EQ 250MG BASE/10ML (EQ 25MG BASE/ML) | injectable | Prescription | INJECTION | AP | Aug 9, 2018 |
| EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | injectable | Prescription | INJECTION | AP | Aug 9, 2018 |
23. MYLAN
Mylan Pharmaceuticals Inc has filed for 1 generic for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Mylan.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2.5MG BASE | tablet | Prescription | ORAL | AB | May 15, 1992 |
24. BRISTOL MYERS
Bristol Myers Co has filed for 1 generic for Methotrexate Sodium. This eq 25mg base/ml version comes by the name MEXATE-AQ. Given below are the details of the strengths of this generic introduced by Bristol Myers.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 25MG BASE/ML
(reference listed drug) | injectable | Discontinued | INJECTION | N/A | Feb 14, 1985 |
25. BRISTOL MYERS SQUIBB
Bristol Myers Squibb has filed for 1 generic for Methotrexate Sodium. This eq 25mg base/ml version comes by the name MEXATE-AQ PRESERVED. Given below are the details of the strengths of this generic introduced by Bristol Myers Squibb.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 25MG BASE/ML | injectable | Discontinued | INJECTION | N/A | Apr 14, 1989 |
26. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 1 generic for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Sun Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2.5MG BASE | tablet | Prescription | ORAL | AB | May 21, 2015 |
27. NORBROOK
Norbrook Laboratories Ltd has filed for 1 generic for Methotrexate Sodium. Given below are the details of the strengths of this generic introduced by Norbrook.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 25MG BASE/ML | injectable | Discontinued | INJECTION | N/A | May 9, 1986 |