NDA (New Drug Application)
ANDA (Generic Application)
It is formulated by 14 pharmaceutical companies such as PLANO PHARMS, SANDOZ, CIPLA and others. It is marketed under 4 brand names, including ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN IN DEXTROSE, ARGATROBAN and others. Available in 4 different strengths, such as 125MG/125ML (1MG/ML), 50MG/50ML (1MG/ML), 250MG/2.5ML (100MG/ML) and others, and administered through 3 routes including INJECTABLE;INTRAVENOUS, SOLUTION;INTRAVENOUS, INJECTABLE;INJECTION.
Track protection status across key markets to assess launch feasibility.
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Licensing: 14 potential partnersUS Launch window: Loading launch window...
FDA approval history for this ingredient
Key expiration dates for US patents covering this ingredient
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":"62396","ingredient":"ARGATROBAN","trade_name":"ARGATROBAN IN SODIUM CHLORIDE","family_id":"6839e853a5e6420ead9c","publication_number":"US7589106B2","cleaned_patent_number":"7589106","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-09-26","publication_date":"2009-09-15","legal_status":"Granted"} | US7589106B2 Formulation | 15 Sep, 2009 | Granted | 26 Sep, 2027 | |
| {"application_id":"62391","ingredient":"ARGATROBAN","trade_name":"ARGATROBAN IN SODIUM CHLORIDE","family_id":"6839e853a5e6420ead9c","publication_number":"US7687516B2","cleaned_patent_number":"7687516","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-09-26","publication_date":"2010-03-30","legal_status":"Granted"} | US7687516B2 Formulation | 30 Mar, 2010 | Granted | 26 Sep, 2027 |
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
Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.