Sofpironium Bromide Global Patent Coverage & Expiry Overview

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It is formulated by 1 pharmaceutical company such as BOTANIX SB. It is marketed under 1 brand name, including SOFDRA. Available in 1 different strength, such as EQ 12.45% BASE (EQ 72MG BASE/ACTUATION), and administered through 1 route including GEL, METERED;TOPICAL.

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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":"138471","ingredient":"SOFPIRONIUM BROMIDE","trade_name":"SOFDRA","family_id":"","publication_number":"US8628759B2","cleaned_patent_number":"8628759","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-13","publication_date":"2014-01-14","legal_status":"Granted"} US8628759B2 14 Jan, 2014 Granted 13 Nov, 2026
{"application_id":"130695","ingredient":"SOFPIRONIUM BROMIDE","trade_name":"SOFDRA","family_id":"","publication_number":"US8147809B2","cleaned_patent_number":"8147809","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-03-26","publication_date":"2012-04-03","legal_status":"Granted"} US8147809B2 Molecular Formulation 03 Apr, 2012 Granted 26 Mar, 2027
{"application_id":"138474","ingredient":"SOFPIRONIUM BROMIDE","trade_name":"SOFDRA","family_id":"","publication_number":"US10383846B2","cleaned_patent_number":"10383846","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-14","publication_date":"2019-08-20","legal_status":"Granted"} US10383846B2 20 Aug, 2019 Granted 14 Mar, 2034
{"application_id":"138477","ingredient":"SOFPIRONIUM BROMIDE","trade_name":"SOFDRA","family_id":"","publication_number":"US9220707B2","cleaned_patent_number":"9220707","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-14","publication_date":"2015-12-29","legal_status":"Patented Case"} US9220707B2 29 Dec, 2015 Patented Case 14 Mar, 2034
{"application_id":"138475","ingredient":"SOFPIRONIUM BROMIDE","trade_name":"SOFDRA","family_id":"","publication_number":"US9492429B2","cleaned_patent_number":"9492429","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-14","publication_date":"2016-11-15","legal_status":"Patented Case"} US9492429B2 Formulation 15 Nov, 2016 Patented Case 14 Mar, 2034
{"application_id":"138476","ingredient":"SOFPIRONIUM BROMIDE","trade_name":"SOFDRA","family_id":"","publication_number":"US9895350B2","cleaned_patent_number":"9895350","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-14","publication_date":"2018-02-20","legal_status":"Patented Case"} US9895350B2 20 Feb, 2018 Patented Case 14 Mar, 2034
{"application_id":"138468","ingredient":"SOFPIRONIUM BROMIDE","trade_name":"SOFDRA","family_id":"","publication_number":"US11026919B2","cleaned_patent_number":"11026919","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-05-22","publication_date":"2021-06-08","legal_status":"Granted"} US11026919B2 Formulation 08 Jun, 2021 Granted 22 May, 2034
{"application_id":"138466","ingredient":"SOFPIRONIUM BROMIDE","trade_name":"SOFDRA","family_id":"","publication_number":"US11052067B2","cleaned_patent_number":"11052067","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-05-22","publication_date":"2021-07-06","legal_status":"Granted"} US11052067B2 Formulation 06 Jul, 2021 Granted 22 May, 2034
{"application_id":"138465","ingredient":"SOFPIRONIUM BROMIDE","trade_name":"SOFDRA","family_id":"","publication_number":"US11084788B2","cleaned_patent_number":"11084788","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-05-22","publication_date":"2021-08-10","legal_status":"Granted"} US11084788B2 Formulation 10 Aug, 2021 Granted 22 May, 2034
{"application_id":"138470","ingredient":"SOFPIRONIUM BROMIDE","trade_name":"SOFDRA","family_id":"","publication_number":"US10959983B2","cleaned_patent_number":"10959983","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-05-22","publication_date":"2021-03-30","legal_status":"Granted"} US10959983B2 30 Mar, 2021 Granted 22 May, 2034
{"application_id":"138469","ingredient":"SOFPIRONIUM BROMIDE","trade_name":"SOFDRA","family_id":"","publication_number":"US10961191B2","cleaned_patent_number":"10961191","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-05-22","publication_date":"2021-03-30","legal_status":"Granted"} US10961191B2 30 Mar, 2021 Granted 22 May, 2034
{"application_id":"138467","ingredient":"SOFPIRONIUM BROMIDE","trade_name":"SOFDRA","family_id":"","publication_number":"US11034652B2","cleaned_patent_number":"11034652","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-05-22","publication_date":"2021-06-15","legal_status":"Granted"} US11034652B2 Formulation 15 Jun, 2021 Granted 22 May, 2034
{"application_id":"242104","ingredient":"SOFPIRONIUM BROMIDE","trade_name":"SOFDRA","family_id":"","publication_number":"US12156865B2","cleaned_patent_number":"12156865","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-05-22","publication_date":"2024-12-03","legal_status":"Granted"} US12156865B2 Formulation 03 Dec, 2024 Granted 22 May, 2034
{"application_id":"138472","ingredient":"SOFPIRONIUM BROMIDE","trade_name":"SOFDRA","family_id":"","publication_number":"US10952990B2","cleaned_patent_number":"10952990","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-05-22","publication_date":"2021-03-23","legal_status":"Granted"} US10952990B2 23 Mar, 2021 Granted 22 May, 2034
{"application_id":"138473","ingredient":"SOFPIRONIUM BROMIDE","trade_name":"SOFDRA","family_id":"","publication_number":"US10947192B2","cleaned_patent_number":"10947192","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-05-22","publication_date":"2021-03-16","legal_status":"Granted"} US10947192B2 16 Mar, 2021 Granted 22 May, 2034
{"application_id":"138464","ingredient":"SOFPIRONIUM BROMIDE","trade_name":"SOFDRA","family_id":"","publication_number":"US11123325B2","cleaned_patent_number":"11123325","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-07-20","publication_date":"2021-09-21","legal_status":"Granted"} US11123325B2 Formulation 21 Sep, 2021 Granted 20 Jul, 2037
{"application_id":"130697","ingredient":"SOFPIRONIUM BROMIDE","trade_name":"SOFDRA","family_id":"","publication_number":"US11566000B2","cleaned_patent_number":"11566000","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-05-22","publication_date":"2023-01-31","legal_status":"Granted"} US11566000B2 Molecular Formulation 31 Jan, 2023 Granted 22 May, 2040
{"application_id":"130696","ingredient":"SOFPIRONIUM BROMIDE","trade_name":"SOFDRA","family_id":"","publication_number":"US11584715B2","cleaned_patent_number":"11584715","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-05-22","publication_date":"2023-02-21","legal_status":"Granted"} US11584715B2 Molecular Formulation 21 Feb, 2023 Granted 22 May, 2040

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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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