NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as PROVEPHARM SAS. It is marketed under 1 brand name, including BLUDIGO. Available in 1 different strength, such as 40MG/5ML (8MG/ML), and administered through 1 route including SOLUTION;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":"120824","ingredient":"INDIGOTINDISULFONATE SODIUM","trade_name":"BLUDIGO","family_id":"ee753fa97ee54ed29b6c","publication_number":"US11845867B2","cleaned_patent_number":"11845867","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-11-25","publication_date":"2023-12-19","legal_status":"Granted"} | US11845867B2 Molecular | 19 Dec, 2023 | Granted | 25 Nov, 2036 | |
| {"application_id":"73179","ingredient":"INDIGOTINDISULFONATE SODIUM","trade_name":"BLUDIGO","family_id":"6a805cfca3d14596bb0f","publication_number":"US10927258B2","cleaned_patent_number":"10927258","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-12-23","publication_date":"2021-02-23","legal_status":"Granted"} | US10927258B2 Molecular | 23 Feb, 2021 | Granted | 23 Dec, 2037 | |
| {"application_id":"73181","ingredient":"INDIGOTINDISULFONATE SODIUM","trade_name":"BLUDIGO","family_id":"6a805cfca3d14596bb0f","publication_number":"US11499050B2","cleaned_patent_number":"11499050","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-12-23","publication_date":"2022-11-15","legal_status":"Granted"} | US11499050B2 Molecular | 15 Nov, 2022 | Granted | 23 Dec, 2037 |
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.