NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as HOPE PHARMS. It is marketed under 2 brand names, including NITHIODOTE, SODIUM NITRITE. Available in 2 different strengths, such as 300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML), 300MG/10ML (30MG/ML), and administered through 2 routes including SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS, 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":"70364","ingredient":"SODIUM NITRITE","trade_name":"NITHIODOTE","family_id":"45a15a16ffec44f2a641","publication_number":"US9687506B2","cleaned_patent_number":"9687506","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-02-10","publication_date":"2017-06-27","legal_status":"Granted"} | US9687506B2 Formulation | 27 Jun, 2017 | Granted | 10 Feb, 2030 | |
| {"application_id":"115537","ingredient":"SODIUM NITRITE; SODIUM THIOSULFATE","trade_name":"NITHIODOTE","family_id":"766b19b9e1e8440bbab3","publication_number":"US11753301B2","cleaned_patent_number":"11753301","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-02-10","publication_date":"2023-09-12","legal_status":"Granted"} | US11753301B2 Molecular Formulation | 12 Sep, 2023 | Granted | 10 Feb, 2030 | |
| {"application_id":"183598","ingredient":"SODIUM NITRITE; SODIUM THIOSULFATE","trade_name":"NITHIODOTE","family_id":"766b19b9e1e8440bbab3","publication_number":"US12304813B2","cleaned_patent_number":"12304813","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-02-10","publication_date":"2025-05-20","legal_status":"Patented case"} | US12304813B2 Formulation | 20 May, 2025 | Patented case | 10 Feb, 2030 | |
| {"application_id":"70328","ingredient":"SODIUM NITRITE; SODIUM THIOSULFATE","trade_name":"NITHIODOTE","family_id":"766b19b9e1e8440bbab3","publication_number":"US10479686B2","cleaned_patent_number":"10479686","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-07-07","publication_date":"2019-11-19","legal_status":"Patented case"} | US10479686B2 Formulation | 19 Nov, 2019 | Patented case | 07 Jul, 2030 | |
| {"application_id":"70324","ingredient":"SODIUM NITRITE; SODIUM THIOSULFATE","trade_name":"NITHIODOTE","family_id":"766b19b9e1e8440bbab3","publication_number":"US9345724B2","cleaned_patent_number":"9345724","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-07-07","publication_date":"2016-05-24","legal_status":"Granted"} | US9345724B2 Molecular Formulation | 24 May, 2016 | Granted | 07 Jul, 2030 | |
| {"application_id":"70326","ingredient":"SODIUM NITRITE; SODIUM THIOSULFATE","trade_name":"NITHIODOTE","family_id":"766b19b9e1e8440bbab3","publication_number":"US9585912B2","cleaned_patent_number":"9585912","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-07-07","publication_date":"2017-03-07","legal_status":"Granted"} | US9585912B2 Molecular Formulation | 07 Mar, 2017 | Granted | 07 Jul, 2030 | |
| {"application_id":"70304","ingredient":"SODIUM NITRITE; SODIUM THIOSULFATE","trade_name":"NITHIODOTE","family_id":"766b19b9e1e8440bbab3","publication_number":"US8496973B2","cleaned_patent_number":"8496973","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-29","publication_date":"2013-07-30","legal_status":"Patented case"} | US8496973B2 Molecular Formulation | 30 Jul, 2013 | Patented case | 29 Mar, 2031 | |
| {"application_id":"70335","ingredient":"SODIUM NITRITE","trade_name":"NITHIODOTE","family_id":"45a15a16ffec44f2a641","publication_number":"US8568793B2","cleaned_patent_number":"8568793","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-12-24","publication_date":"2013-10-29","legal_status":"Granted"} | US8568793B2 Molecular Formulation | 29 Oct, 2013 | Granted | 24 Dec, 2031 |
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.