Norepinephrine Bitartrate Global Patent Coverage & Expiry Overview

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It is formulated by 16 pharmaceutical companies such as BAXTER HLTHCARE CORP, MYLAN LABS LTD, SANDOZ and others. It is marketed under 3 brand names, including NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE, NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE. Available in 5 different strengths, such as EQ 1MG BASE/ML, EQ 8MG BASE/250ML (EQ 32MCG BASE/ML), EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) and others, and administered through 2 routes including INJECTABLE;INJECTION, 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":"164434","ingredient":"NOREPINEPHRINE BITARTRATE","trade_name":"NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE","family_id":"","publication_number":"USRE49443E","cleaned_patent_number":"RE49443","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-02-26","publication_date":"2023-03-07","legal_status":"Granted"} USRE49443E1 Formulation 07 Mar, 2023 Granted 26 Feb, 2035
{"application_id":"164432","ingredient":"NOREPINEPHRINE BITARTRATE","trade_name":"NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE","family_id":"","publication_number":"USRE49422E","cleaned_patent_number":"RE49422","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-02-26","publication_date":"2023-02-21","legal_status":"Granted"} USRE49422E1 Formulation 21 Feb, 2023 Granted 26 Feb, 2035
{"application_id":"164433","ingredient":"NOREPINEPHRINE BITARTRATE","trade_name":"NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE","family_id":"","publication_number":"US10251848B2","cleaned_patent_number":"10251848","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-02-26","publication_date":"2019-04-09","legal_status":"Granted"} US10251848B2 Formulation 09 Apr, 2019 Granted 26 Feb, 2035
{"application_id":"108557","ingredient":"NOREPINEPHRINE BITARTRATE","trade_name":"NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE","family_id":"78b0053c851847818923","publication_number":"US10568850B2","cleaned_patent_number":"10568850","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-01-30","publication_date":"2020-02-25","legal_status":"Granted"} US10568850B2 Formulation 25 Feb, 2020 Granted 30 Jan, 2038
{"application_id":"108553","ingredient":"NOREPINEPHRINE BITARTRATE","trade_name":"NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE","family_id":"78b0053c851847818923","publication_number":"US10159657B2","cleaned_patent_number":"10159657","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-01-30","publication_date":"2018-12-25","legal_status":"Granted"} US10159657B2 Formulation 25 Dec, 2018 Granted 30 Jan, 2038
{"application_id":"111794","ingredient":"NOREPINEPHRINE BITARTRATE","trade_name":"NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE","family_id":"0b697d9d56d046be8f53","publication_number":"US11602508B2","cleaned_patent_number":"11602508","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-01-30","publication_date":"2023-03-14","legal_status":"Granted"} US11602508B2 Formulation 14 Mar, 2023 Granted 30 Jan, 2038
{"application_id":"111795","ingredient":"NOREPINEPHRINE BITARTRATE","trade_name":"NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE","family_id":"0b697d9d56d046be8f53","publication_number":"US2022409558A1","cleaned_patent_number":"12245996","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-01-30","publication_date":"2022-12-29","legal_status":"Pending"} US12245996B2 Formulation 29 Dec, 2022 Pending 30 Jan, 2038
{"application_id":"108551","ingredient":"NOREPINEPHRINE BITARTRATE","trade_name":"NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE","family_id":"78b0053c851847818923","publication_number":"US11413259B2","cleaned_patent_number":"11413259","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-01-30","publication_date":"2022-08-16","legal_status":"Granted"} US11413259B2 Formulation 16 Aug, 2022 Granted 30 Jan, 2038
{"application_id":"108554","ingredient":"NOREPINEPHRINE BITARTRATE","trade_name":"NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE","family_id":"78b0053c851847818923","publication_number":"US10226436B2","cleaned_patent_number":"10226436","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-01-30","publication_date":"2019-03-12","legal_status":"Granted"} US10226436B2 Formulation 12 Mar, 2019 Granted 30 Jan, 2038
{"application_id":"108555","ingredient":"NOREPINEPHRINE BITARTRATE","trade_name":"NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE","family_id":"78b0053c851847818923","publication_number":"US10420735B2","cleaned_patent_number":"10420735","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-01-30","publication_date":"2019-09-24","legal_status":"Granted"} US10420735B2 Formulation 24 Sep, 2019 Granted 30 Jan, 2038
{"application_id":"108108","ingredient":"NOREPINEPHRINE BITARTRATE","trade_name":"NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE","family_id":"fb1a1ef4ff6f406a946d","publication_number":"US10888534B2","cleaned_patent_number":"10888534","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-04-26","publication_date":"2021-01-12","legal_status":"Granted"} US10888534B2 Formulation 12 Jan, 2021 Granted 26 Apr, 2039
{"application_id":"242127","ingredient":"NOREPINEPHRINE BITARTRATE","trade_name":"NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE","family_id":"","publication_number":"US12290494B2","cleaned_patent_number":"12290494","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-03-08","publication_date":"2025-05-06","legal_status":"Granted"} US12290494B2 Formulation 06 May, 2025 Granted 08 Mar, 2041
{"application_id":"130705","ingredient":"NOREPINEPHRINE BITARTRATE","trade_name":"NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE","family_id":"","publication_number":"US12097170B2","cleaned_patent_number":"12097170","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-03-08","publication_date":"2024-09-24","legal_status":"Granted"} US12097170B2 Formulation 24 Sep, 2024 Granted 08 Mar, 2041

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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