NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 23 pharmaceutical companies such as EAGLE PHARMS, ACTAVIS, APOTEX and others. It is marketed under 5 brand names, including PEMFEXY, PEMETREXED, PEMETREXED DISODIUM and others. Available in 14 different strengths, such as 500MG/20ML (25MG/ML), 100MG/4ML (25MG/ML), 1GM/40ML (25MG/ML) and others, and administered through 2 routes including SOLUTION;INTRAVENOUS, POWDER;INTRAVENOUS.
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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":"115845","ingredient":"PEMETREXED DISODIUM","trade_name":"PEMETREXED","family_id":"7255cf1e89924abc8357","publication_number":"US11147817B2","cleaned_patent_number":"11147817","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-03-26","publication_date":"2021-10-19","legal_status":"Granted"} | US11147817B2 Formulation | 19 Oct, 2021 | Granted | 26 Mar, 2035 | |
| {"application_id":"41042","ingredient":"PEMETREXED","trade_name":"PEMFEXY","family_id":"8c2679f171a243a088f1","publication_number":"US9604990B2","cleaned_patent_number":"9604990","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-10-28","publication_date":"2017-03-28","legal_status":"Granted"} | US9604990B2 Molecular | 28 Mar, 2017 | Granted | 28 Oct, 2035 | |
| {"application_id":"117526","ingredient":"PEMETREXED","trade_name":"PEMFEXY","family_id":"339f4014c5914a6b8a33","publication_number":"US11793813B2","cleaned_patent_number":"11793813","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-02-19","publication_date":"2023-10-24","legal_status":"Granted"} | US11793813B2 Formulation | 24 Oct, 2023 | Granted | 19 Feb, 2036 |
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.