Cysteine Hydrochloride Global Patent Coverage & Expiry Overview

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It is formulated by 2 pharmaceutical companies such as EXELA PHARMA, BAXTER HLTHCARE CORP. It is marketed under 2 brand names, including ELCYS, NOURESS. Available in 2 different strengths, such as 500MG/10ML (50MG/ML), 2500MG/50ML (50MG/ML), and administered through 1 route including 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":"117622","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"ELCYS","family_id":"0bd91be8cc7c4975a28e","publication_number":"US11969439B1","cleaned_patent_number":"11969439","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-15","publication_date":"2024-04-30","legal_status":"Granted"} US11969439B2 30 Apr, 2024 Granted 15 Jan, 2039
{"application_id":"118482","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"ELCYS","family_id":"0bd91be8cc7c4975a28e","publication_number":"US11648262B1","cleaned_patent_number":"11648262","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-15","publication_date":"2023-05-16","legal_status":"Patented case"} US11648262B2 Formulation 16 May, 2023 Patented case 15 Jan, 2039
{"application_id":"109655","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"ELCYS","family_id":"0bd91be8cc7c4975a28e","publication_number":"US11679125B1","cleaned_patent_number":"11679125","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-15","publication_date":"2023-06-20","legal_status":"Patented case"} US11679125B2 Formulation 20 Jun, 2023 Patented case 15 Jan, 2039
{"application_id":"109610","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"ELCYS","family_id":"0bd91be8cc7c4975a28e","publication_number":"US11684636B1","cleaned_patent_number":"11684636","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-15","publication_date":"2023-06-27","legal_status":"Patented case"} US11684636B2 Formulation 27 Jun, 2023 Patented case 15 Jan, 2039
{"application_id":"113067","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"ELCYS","family_id":"0bd91be8cc7c4975a28e","publication_number":"US11826383B1","cleaned_patent_number":"11826383","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-15","publication_date":"2023-11-28","legal_status":"Granted"} US11826383B2 Formulation 28 Nov, 2023 Granted 15 Jan, 2039
{"application_id":"36713","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"ELCYS","family_id":"0bd91be8cc7c4975a28e","publication_number":"US10478453B1","cleaned_patent_number":"10478453","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-15","publication_date":"2019-11-19","legal_status":"Granted"} US10478453B2 Formulation 19 Nov, 2019 Granted 15 Jan, 2039
{"application_id":"36714","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"ELCYS","family_id":"0bd91be8cc7c4975a28e","publication_number":"US10583155B1","cleaned_patent_number":"10583155","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-15","publication_date":"2020-03-10","legal_status":"Granted"} US10583155B2 Formulation 10 Mar, 2020 Granted 15 Jan, 2039
{"application_id":"36715","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"ELCYS","family_id":"0bd91be8cc7c4975a28e","publication_number":"US10653719B1","cleaned_patent_number":"10653719","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-15","publication_date":"2020-05-19","legal_status":"Granted"} US10653719B2 Formulation 19 May, 2020 Granted 15 Jan, 2039
{"application_id":"36717","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"ELCYS","family_id":"0bd91be8cc7c4975a28e","publication_number":"US10905713B2","cleaned_patent_number":"10905713","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-15","publication_date":"2021-02-02","legal_status":"Granted"} US10905713B2 Formulation 02 Feb, 2021 Granted 15 Jan, 2039
{"application_id":"36718","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"ELCYS","family_id":"0bd91be8cc7c4975a28e","publication_number":"US10905714B1","cleaned_patent_number":"10905714","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-15","publication_date":"2021-02-02","legal_status":"Granted"} US10905714B2 Formulation 02 Feb, 2021 Granted 15 Jan, 2039
{"application_id":"36719","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"ELCYS","family_id":"0bd91be8cc7c4975a28e","publication_number":"US10912795B1","cleaned_patent_number":"10912795","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-15","publication_date":"2021-02-09","legal_status":"Patented case"} US10912795B2 Formulation 09 Feb, 2021 Patented case 15 Jan, 2039
{"application_id":"1537","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"ELCYS","family_id":"0bd91be8cc7c4975a28e","publication_number":"US10918662B1","cleaned_patent_number":"10918662","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-15","publication_date":"2021-02-16","legal_status":"Granted"} US10918662B2 Formulation 16 Feb, 2021 Granted 15 Jan, 2039
{"application_id":"36716","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"ELCYS","family_id":"0bd91be8cc7c4975a28e","publication_number":"US10933089B1","cleaned_patent_number":"10933089","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-15","publication_date":"2021-03-02","legal_status":"Granted"} US10933089B2 Formulation 02 Mar, 2021 Granted 15 Jan, 2039
{"application_id":"109374","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"ELCYS","family_id":"0bd91be8cc7c4975a28e","publication_number":"US11510942B1","cleaned_patent_number":"11510942","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-15","publication_date":"2022-11-29","legal_status":"Granted"} US11510942B2 Formulation 29 Nov, 2022 Granted 15 Jan, 2039
{"application_id":"118481","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"ELCYS","family_id":"0bd91be8cc7c4975a28e","publication_number":"US11642370B1","cleaned_patent_number":"11642370","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-15","publication_date":"2023-05-09","legal_status":"Granted"} US11642370B2 Formulation 09 May, 2023 Granted 15 Jan, 2039
{"application_id":"109375","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"ELCYS","family_id":"0bd91be8cc7c4975a28e","publication_number":"US11510941B1","cleaned_patent_number":"11510941","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-03-02","publication_date":"2022-11-29","legal_status":"Granted"} US11510941B2 Formulation 29 Nov, 2022 Granted 02 Mar, 2039
{"application_id":"35135","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"NOURESS","family_id":"f57a492731ae4abb8b52","publication_number":"US10493051B1","cleaned_patent_number":"10493051","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-03-15","publication_date":"2019-12-03","legal_status":"Granted"} US10493051B2 Formulation 03 Dec, 2019 Granted 15 Mar, 2039
{"application_id":"35136","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"NOURESS","family_id":"f8cdc7c460094d5ca32b","publication_number":"US10543186B1","cleaned_patent_number":"10543186","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-03-15","publication_date":"2020-01-28","legal_status":"Granted"} US10543186B2 28 Jan, 2020 Granted 15 Mar, 2039
{"application_id":"35138","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"NOURESS","family_id":"f8cdc7c460094d5ca32b","publication_number":"US11045438B2","cleaned_patent_number":"11045438","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-03-15","publication_date":"2021-06-29","legal_status":"Granted"} US11045438B2 Formulation 29 Jun, 2021 Granted 15 Mar, 2039
{"application_id":"35137","ingredient":"CYSTEINE HYDROCHLORIDE","trade_name":"NOURESS","family_id":"f8cdc7c460094d5ca32b","publication_number":"US10702490B1","cleaned_patent_number":"10702490","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-03-15","publication_date":"2020-07-07","legal_status":"Granted"} US10702490B2 Formulation 07 Jul, 2020 Granted 15 Mar, 2039

Recent Clinical Trials

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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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