NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as GERON. It is marketed under 1 brand name, including RYTELO. Available in 2 different strengths, such as EQ 47MG BASE/VIAL, EQ 188MG BASE/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":"124061","ingredient":"IMETELSTAT SODIUM","trade_name":"RYTELO","family_id":"","publication_number":"US7494982B2","cleaned_patent_number":"7494982","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-12-27","publication_date":"2009-02-24","legal_status":"Expired"} | US7494982B2 Molecular Formulation | 24 Feb, 2009 | Expired | 27 Dec, 2025 | |
| {"application_id":"124060","ingredient":"IMETELSTAT SODIUM","trade_name":"RYTELO","family_id":"","publication_number":"US9375485B2","cleaned_patent_number":"9375485","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-15","publication_date":"2016-06-28","legal_status":"Granted"} | US9375485B2 | 28 Jun, 2016 | Granted | 15 Mar, 2033 | |
| {"application_id":"139381","ingredient":"IMETELSTAT SODIUM","trade_name":"RYTELO","family_id":"","publication_number":"US12171778B2","cleaned_patent_number":"12171778","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-06-16","publication_date":"2024-12-24","legal_status":"Granted"} | US12171778B2 | 24 Dec, 2024 | Granted | 16 Jun, 2039 |
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.