NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as GENZYME CORP. It is marketed under 1 brand name, including QFITLIA. Available in 2 different strengths, such as EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML), EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML), and administered through 1 route including SOLUTION;SUBCUTANEOUS.
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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":"164442","ingredient":"FITUSIRAN SODIUM","trade_name":"QFITLIA","family_id":"","publication_number":"US9376680B2","cleaned_patent_number":"9376680","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-15","publication_date":"2016-06-28","legal_status":"Granted"} | US9376680B2 Molecular Formulation | 28 Jun, 2016 | Granted | 15 Mar, 2033 | |
| {"application_id":"164443","ingredient":"FITUSIRAN SODIUM","trade_name":"QFITLIA","family_id":"","publication_number":"US9127274B2","cleaned_patent_number":"9127274","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-22","publication_date":"2015-09-08","legal_status":"Granted"} | US9127274B2 Molecular Formulation | 08 Sep, 2015 | Granted | 22 Mar, 2033 | |
| {"application_id":"164441","ingredient":"FITUSIRAN SODIUM","trade_name":"QFITLIA","family_id":"29810c6331c94e6aad4c","publication_number":"US11091759B2","cleaned_patent_number":"11091759","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-12-07","publication_date":"2021-08-17","legal_status":"Granted"} | US11091759B2 | 17 Aug, 2021 | Granted | 07 Dec, 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.