NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 14 pharmaceutical companies such as PHARMACHEMIE BV, EXTROVIS, EUGIA PHARMA SPECLTS and others. It is marketed under 3 brand names, including METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM, XATMEP. Available in 7 different strengths, such as EQ 1GM BASE/40ML (EQ 25MG BASE/ML), EQ 50MG BASE/2ML (EQ 25MG BASE/ML), EQ 250MG BASE/10ML (EQ 25MG BASE/ML) and others, and administered through 3 routes including INJECTABLE;INJECTION, TABLET;ORAL, SOLUTION;ORAL.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
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Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"77011","ingredient":"METHOTREXATE SODIUM","trade_name":"XATMEP","family_id":"9533fa5fa2db4a9a96e1","publication_number":"US10231927B2","cleaned_patent_number":"10231927","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-02","publication_date":"2019-03-19","legal_status":"Granted"} | US10231927B2 | 19 Mar, 2019 | Granted | 02 Jan, 2033 | |
| {"application_id":"77017","ingredient":"METHOTREXATE SODIUM","trade_name":"XATMEP","family_id":"9533fa5fa2db4a9a96e1","publication_number":"US10610485B2","cleaned_patent_number":"10610485","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-02","publication_date":"2020-04-07","legal_status":"Granted"} | US10610485B2 Formulation | 07 Apr, 2020 | Granted | 02 Jan, 2033 | |
| {"application_id":"77018","ingredient":"METHOTREXATE SODIUM","trade_name":"XATMEP","family_id":"9533fa5fa2db4a9a96e1","publication_number":"US11116724B2","cleaned_patent_number":"11116724","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-02","publication_date":"2021-09-14","legal_status":"Granted"} | US11116724B2 | 14 Sep, 2021 | Granted | 02 Jan, 2033 | |
| {"application_id":"77019","ingredient":"METHOTREXATE SODIUM","trade_name":"XATMEP","family_id":"9533fa5fa2db4a9a96e1","publication_number":"US11969503B2","cleaned_patent_number":"11969503","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-02","publication_date":"2024-04-30","legal_status":"Granted"} | US11969503B2 Formulation | 30 Apr, 2024 | Granted | 02 Jan, 2033 | |
| {"application_id":"77015","ingredient":"METHOTREXATE SODIUM","trade_name":"XATMEP","family_id":"9533fa5fa2db4a9a96e1","publication_number":"US9259427B2","cleaned_patent_number":"9259427","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-02","publication_date":"2016-02-16","legal_status":"Granted"} | US9259427B2 Formulation | 16 Feb, 2016 | Granted | 02 Jan, 2033 | |
| {"application_id":"77016","ingredient":"METHOTREXATE SODIUM","trade_name":"XATMEP","family_id":"9533fa5fa2db4a9a96e1","publication_number":"US9855215B2","cleaned_patent_number":"9855215","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-02","publication_date":"2018-01-02","legal_status":"Granted"} | US9855215B2 Formulation | 02 Jan, 2018 | Granted | 02 Jan, 2033 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
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Manufacturing Locations
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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.