Sodium Thiosulfate Global Patent Coverage & Expiry Overview

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It is formulated by 2 pharmaceutical companies such as HOPE PHARMS, FENNEC PHARMS INC. It is marketed under 3 brand names, including NITHIODOTE, SODIUM THIOSULFATE, PEDMARK. Available in 3 different strengths, such as 300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML), 12.5GM/50ML (250MG/ML), 12.5GM/100ML (125MG/ML), and administered through 2 routes including SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS, SOLUTION;INTRAVENOUS.

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Sourcing & Feasibility

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

NDA (New Drug Application) ANDA (Generic Application)

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US Orange Book Patents Expiration Timeline

Key expiration dates for US patents covering this ingredient

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Orange Book Drug Strengths

Latest drug strengths approved by FDA

Strength Route of Administration Companies Latest Approval Date

Orange Book Patents

Patents approved by the FDA for the ingredient

Patent Number Publication Date Legal Status Patent Expiry Date
{"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":"70364","ingredient":"SODIUM NITRITE; SODIUM THIOSULFATE","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":"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; SODIUM THIOSULFATE","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
{"application_id":"108561","ingredient":"SODIUM THIOSULFATE","trade_name":"PEDMARK","family_id":"480d18d4ca704cdfbc52","publication_number":"US10596190B2","cleaned_patent_number":"10596190","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-01-05","publication_date":"2020-03-24","legal_status":"Granted"} US10596190B2 24 Mar, 2020 Granted 05 Jan, 2038
{"application_id":"108576","ingredient":"SODIUM THIOSULFATE","trade_name":"PEDMARK","family_id":"037d178759f741228135","publication_number":"US11291728B2","cleaned_patent_number":"11291728","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-07-01","publication_date":"2022-04-05","legal_status":"Granted"} US11291728B2 Formulation 05 Apr, 2022 Granted 01 Jul, 2039
{"application_id":"109900","ingredient":"SODIUM THIOSULFATE","trade_name":"PEDMARK","family_id":"b2613494d0854ffa9b13","publication_number":"US11617793B2","cleaned_patent_number":"11617793","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-07-01","publication_date":"2023-04-04","legal_status":"Granted"} US11617793B2 Formulation 04 Apr, 2023 Granted 01 Jul, 2039
{"application_id":"123007","ingredient":"SODIUM THIOSULFATE","trade_name":"PEDMARK","family_id":"037d178759f741228135","publication_number":"US11964018B2","cleaned_patent_number":"11964018","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-07-01","publication_date":"2024-04-23","legal_status":"Granted"} US11964018B2 23 Apr, 2024 Granted 01 Jul, 2039
{"application_id":"108600","ingredient":"SODIUM THIOSULFATE","trade_name":"PEDMARK","family_id":"b92a34dfe19043388088","publication_number":"US11510984B2","cleaned_patent_number":"11510984","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-07-01","publication_date":"2022-11-29","legal_status":"Granted"} US11510984B2 Formulation 29 Nov, 2022 Granted 01 Jul, 2039
{"application_id":"112686","ingredient":"SODIUM THIOSULFATE","trade_name":"PEDMARK","family_id":"b2613494d0854ffa9b13","publication_number":"US11992530B2","cleaned_patent_number":"11992530","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-07-01","publication_date":"2024-05-28","legal_status":"Granted"} US11992530B2 28 May, 2024 Granted 01 Jul, 2039
{"application_id":"123008","ingredient":"SODIUM THIOSULFATE","trade_name":"PEDMARK","family_id":"037d178759f741228135","publication_number":"US11998604B2","cleaned_patent_number":"11998604","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-07-01","publication_date":"2024-06-04","legal_status":"Granted"} US11998604B2 04 Jun, 2024 Granted 01 Jul, 2039

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

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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.

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