NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 7 pharmaceutical companies such as FRESENIUS KABI USA, NORVIUM BIOSCIENCE, GLAND and others. It is marketed under 1 brand name, including CASPOFUNGIN ACETATE. Available in 2 different strengths, such as 70MG/VIAL, 50MG/VIAL, and administered through 1 route including 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":"66566","ingredient":"CASPOFUNGIN ACETATE","trade_name":"CASPOFUNGIN ACETATE","family_id":"b9b5b7a96d3540519c9f","publication_number":"US9636407B2","cleaned_patent_number":"9636407","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-12-21","publication_date":"2017-05-02","legal_status":"Granted"} | US9636407B2 Formulation | 02 May, 2017 | Granted | 21 Dec, 2032 |
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.