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It is formulated by 3 pharmaceutical companies such as EAGLE PHARMS, EUGIA PHARMA SPECLTS, HIKMA. It is marketed under 2 brand names, including RYANODEX, DANTROLENE SODIUM. Available in 2 different strengths, such as 250MG/VIAL, 20MG/VIAL, and administered through 2 routes including FOR SUSPENSION;INTRAVENOUS, INJECTABLE;INJECTION.
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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 | |
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{"application_id":"58228","ingredient":"DANTROLENE SODIUM","trade_name":"RYANODEX","family_id":"2ada4b37441b4df78c33","publication_number":"US7758890B2","cleaned_patent_number":"7758890","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-06-30","publication_date":"2010-07-20","legal_status":"Granted"} | US7758890B2 Formulation | 20 Jul, 2010 | Granted | 30 Jun, 2025 |
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.