NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 20 pharmaceutical companies such as HIKMA, HENGRUI PHARMA, ANI PHARMS and others. It is marketed under 1 brand name, including CYCLOPHOSPHAMIDE. Available in 14 different strengths, such as 25MG, 50MG, 1GM/VIAL and others, and administered through 3 routes including CAPSULE;ORAL, INJECTABLE;INJECTION, SOLUTION;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":"73395","ingredient":"CYCLOPHOSPHAMIDE","trade_name":"CYCLOPHOSPHAMIDE","family_id":"c77d783323754a59b9db","publication_number":"US9662342B2","cleaned_patent_number":"9662342","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-06-26","publication_date":"2017-05-30","legal_status":"Granted"} | US9662342B2 Formulation | 30 May, 2017 | Granted | 26 Jun, 2035 | |
| {"application_id":"115776","ingredient":"CYCLOPHOSPHAMIDE","trade_name":"CYCLOPHOSPHAMIDE","family_id":"bd91fe4e7bc142ec8edf","publication_number":"US10849916B2","cleaned_patent_number":"10849916","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-07-13","publication_date":"2020-12-01","legal_status":"Patented case"} | US10849916B2 Formulation | 01 Dec, 2020 | Patented case | 13 Jul, 2035 | |
| {"application_id":"115777","ingredient":"CYCLOPHOSPHAMIDE","trade_name":"CYCLOPHOSPHAMIDE","family_id":"bd91fe4e7bc142ec8edf","publication_number":"US11382923B2","cleaned_patent_number":"11382923","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-12-01","publication_date":"2022-07-12","legal_status":"Granted"} | US11382923B2 Formulation | 12 Jul, 2022 | Granted | 01 Dec, 2035 | |
| {"application_id":"73408","ingredient":"CYCLOPHOSPHAMIDE","trade_name":"CYCLOPHOSPHAMIDE","family_id":"84d25da759e54c5fbc9f","publication_number":"US10993952B2","cleaned_patent_number":"10993952","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-02-15","publication_date":"2021-05-04","legal_status":"Granted"} | US10993952B2 Formulation | 04 May, 2021 | Granted | 15 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.