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 in its drug Methotrexate Sodium on Approved Prior to Jan 1, 1982. Other drugs containing Methotrexate Sodium are Methotrexate Lpf, Methotrexate Preservative Free, Methotrexate Sodium Preservative Free, Xatmep. 30 different companies have introduced drugs containing Methotrexate Sodium.


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.

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

Activity Date Patent Number
Patent litigations
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


Methotrexate Sodium's Family Patents

Family Patents

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Methotrexate Sodium Generic API Manufacturers

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, along with the locations of their manufacturing plants worldwide.