Glycopyrrolate Global Patent Coverage & Expiry Overview

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It is formulated by 45 pharmaceutical companies such as MERZ PHARMS, HIKMA FARMACEUTICA, OXFORD PHARMS and others. It is marketed under 10 brand names, including CUVPOSA, GLYCOPYRROLATE, UTIBRON NEOHALER and others. Available in 17 different strengths, such as 1MG/5ML, 0.2MG/ML, 2MG and others, and administered through 9 routes including SOLUTION;ORAL, INJECTABLE;INJECTION, TABLET;ORAL and others.

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Sourcing & Feasibility

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

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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":"65473","ingredient":"GLYCOPYRROLATE; INDACATEROL MALEATE","trade_name":"UTIBRON NEOHALER","family_id":"fee51c667a404e40b974","publication_number":"US6878721B1","cleaned_patent_number":"6878721","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-02-25","publication_date":"2005-04-12","legal_status":"Court Proceedings Terminated"} US6878721B2 Molecular Formulation 12 Apr, 2005 Court Proceedings Terminated 25 Feb, 2025
{"application_id":"71291","ingredient":"GLYCOPYRROLATE","trade_name":"LONHALA MAGNAIR KIT","family_id":"372403abdcd74e31aeae","publication_number":"US7931212B2","cleaned_patent_number":"7931212","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-11-25","publication_date":"2011-04-26","legal_status":"Granted"} US7931212B2 Formulation 26 Apr, 2011 Granted 25 Nov, 2025
{"application_id":"71243","ingredient":"GLYCOPYRROLATE","trade_name":"LONHALA MAGNAIR KIT","family_id":"60d8acb5dc524454af8b","publication_number":"US11278683B2","cleaned_patent_number":"11278683","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-08-16","publication_date":"2022-03-22","legal_status":"Granted"} US11278683B2 Formulation 22 Mar, 2022 Granted 16 Aug, 2026
{"application_id":"65526","ingredient":"GLYCOPYRROLATE","trade_name":"SEEBRI NEOHALER","family_id":"f3c6c91bff1b48c0bba2","publication_number":"US8479730B2","cleaned_patent_number":"8479730","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-10-11","publication_date":"2013-07-09","legal_status":"Granted"} US8479730B2 Formulation 09 Jul, 2013 Granted 11 Oct, 2028
{"application_id":"65669","ingredient":"GLYCOPYRROLATE","trade_name":"SEEBRI NEOHALER","family_id":"1e5aaa1f8a784685a4fc","publication_number":"US8182838B2","cleaned_patent_number":"8182838","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-10-20","publication_date":"2012-05-22","legal_status":"Granted"} US8182838B2 Formulation 22 May, 2012 Granted 20 Oct, 2028
{"application_id":"71257","ingredient":"GLYCOPYRROLATE","trade_name":"LONHALA MAGNAIR KIT","family_id":"1eecc3848bf5455aa6e9","publication_number":"US9265900B2","cleaned_patent_number":"9265900","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-12-07","publication_date":"2016-02-23","legal_status":"Expired"} US9265900B2 Formulation 23 Feb, 2016 Expired 07 Dec, 2028
{"application_id":"71200","ingredient":"GLYCOPYRROLATE","trade_name":"LONHALA MAGNAIR KIT","family_id":"b0eab2b7898c4dfb9560","publication_number":"US10940110B2","cleaned_patent_number":"10940110","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-26","publication_date":"2021-03-09","legal_status":"Granted"} US10940110B2 Formulation 09 Mar, 2021 Granted 26 Feb, 2029
{"application_id":"43318","ingredient":"BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE","trade_name":"BEVESPI AEROSPHERE","family_id":"b7a1dcda33db49ccb35b","publication_number":"US9415009B2","cleaned_patent_number":"9415009","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-05-28","publication_date":"2016-08-16","legal_status":"Granted"} US9415009B2 16 Aug, 2016 Granted 28 May, 2030
{"application_id":"43319","ingredient":"BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE","trade_name":"BEVESPI AEROSPHERE","family_id":"b7a1dcda33db49ccb35b","publication_number":"US9463161B2","cleaned_patent_number":"9463161","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-05-28","publication_date":"2016-10-11","legal_status":"Granted"} US9463161B2 Formulation 11 Oct, 2016 Granted 28 May, 2030
{"application_id":"43320","ingredient":"BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE","trade_name":"BEVESPI AEROSPHERE","family_id":"b7a1dcda33db49ccb35b","publication_number":"US10716753B2","cleaned_patent_number":"10716753","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-05-28","publication_date":"2020-07-21","legal_status":"Granted"} US10716753B2 Formulation 21 Jul, 2020 Granted 28 May, 2030
{"application_id":"43316","ingredient":"BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE","trade_name":"BEVESPI AEROSPHERE","family_id":"b7a1dcda33db49ccb35b","publication_number":"US8808713B2","cleaned_patent_number":"8808713","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-05-28","publication_date":"2014-08-19","legal_status":"Granted"} US8808713B2 Formulation 19 Aug, 2014 Granted 28 May, 2030
{"application_id":"43315","ingredient":"BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE","trade_name":"BEVESPI AEROSPHERE","family_id":"b7a1dcda33db49ccb35b","publication_number":"US8703806B2","cleaned_patent_number":"8703806","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-05-28","publication_date":"2014-04-22","legal_status":"Granted"} US8703806B2 22 Apr, 2014 Granted 28 May, 2030
{"application_id":"43174","ingredient":"BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE","trade_name":"BEVESPI AEROSPHERE","family_id":"b7a1dcda33db49ccb35b","publication_number":"US8324266B2","cleaned_patent_number":"8324266","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-05-28","publication_date":"2012-12-04","legal_status":"Granted"} US8324266B2 04 Dec, 2012 Granted 28 May, 2030
{"application_id":"71231","ingredient":"GLYCOPYRROLATE","trade_name":"LONHALA MAGNAIR KIT","family_id":"60d8acb5dc524454af8b","publication_number":"US9789270B2","cleaned_patent_number":"9789270","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-10-30","publication_date":"2017-10-17","legal_status":"Granted"} US9789270B2 Formulation 17 Oct, 2017 Granted 30 Oct, 2030
{"application_id":"43317","ingredient":"BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE","trade_name":"BEVESPI AEROSPHERE","family_id":"b7a1dcda33db49ccb35b","publication_number":"US8815258B2","cleaned_patent_number":"8815258","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-17","publication_date":"2014-08-26","legal_status":"Granted"} US8815258B2 26 Aug, 2014 Granted 17 Mar, 2031
{"application_id":"71245","ingredient":"GLYCOPYRROLATE","trade_name":"LONHALA MAGNAIR KIT","family_id":"00b67c60c66947afbd90","publication_number":"US9168556B2","cleaned_patent_number":"9168556","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-09-01","publication_date":"2015-10-27","legal_status":"Granted"} US9168556B2 Formulation 27 Oct, 2015 Granted 01 Sep, 2032
{"application_id":"71278","ingredient":"GLYCOPYRROLATE","trade_name":"LONHALA MAGNAIR KIT","family_id":"16ddd5c207db4877a688","publication_number":"US9604018B2","cleaned_patent_number":"9604018","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-05-16","publication_date":"2017-03-28","legal_status":"Granted"} US9604018B2 Formulation 28 Mar, 2017 Granted 16 May, 2033
{"application_id":"71250","ingredient":"GLYCOPYRROLATE","trade_name":"LONHALA MAGNAIR KIT","family_id":"1c035663352c41ca8f66","publication_number":"US10376661B2","cleaned_patent_number":"10376661","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-09-14","publication_date":"2019-08-13","legal_status":"Granted"} US10376661B2 Formulation 13 Aug, 2019 Granted 14 Sep, 2035
{"application_id":"71270","ingredient":"GLYCOPYRROLATE","trade_name":"LONHALA MAGNAIR KIT","family_id":"b1a7fe39a45849c1a916","publication_number":"US10688518B2","cleaned_patent_number":"10688518","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-11-12","publication_date":"2020-06-23","legal_status":"Granted"} US10688518B2 Formulation 23 Jun, 2020 Granted 12 Nov, 2036
{"application_id":"71217","ingredient":"GLYCOPYRROLATE","trade_name":"LONHALA MAGNAIR KIT","family_id":"3ada03d369ad49b88370","publication_number":"US10744277B2","cleaned_patent_number":"10744277","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-12-07","publication_date":"2020-08-18","legal_status":"Granted"} US10744277B2 Formulation 18 Aug, 2020 Granted 07 Dec, 2036
{"application_id":"43343","ingredient":"BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE","trade_name":"BREZTRI AEROSPHERE","family_id":"bff98297e8ad4b09adb0","publication_number":"US11331442B2","cleaned_patent_number":"11331442","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-10-05","publication_date":"2022-05-17","legal_status":"Granted"} US11331442B2 Formulation 17 May, 2022 Granted 05 Oct, 2038
{"application_id":"43354","ingredient":"BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE","trade_name":"BREZTRI AEROSPHERE","family_id":"bff98297e8ad4b09adb0","publication_number":"US11833292B2","cleaned_patent_number":"11833292","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-10-05","publication_date":"2023-12-05","legal_status":"Granted"} US11833292B2 Formulation 05 Dec, 2023 Granted 05 Oct, 2038
{"application_id":"138496","ingredient":"GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE","trade_name":"PREVDUO","family_id":"","publication_number":"US12151020B2","cleaned_patent_number":"12151020","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-10-25","publication_date":"2024-11-26","legal_status":"Granted"} US12151020B2 Formulation 26 Nov, 2024 Granted 25 Oct, 2038
{"application_id":"111316","ingredient":"GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE","trade_name":"PREVDUO","family_id":"","publication_number":"US10456354B1","cleaned_patent_number":"10456354","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-10-25","publication_date":"2019-10-29","legal_status":"Granted"} US10456354B2 Formulation 29 Oct, 2019 Granted 25 Oct, 2038
{"application_id":"122902","ingredient":"GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE","trade_name":"PREVDUO","family_id":"","publication_number":"US11938217B2","cleaned_patent_number":"11938217","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-10-25","publication_date":"2024-03-26","legal_status":"Granted"} US11938217B2 Formulation 26 Mar, 2024 Granted 25 Oct, 2038
{"application_id":"111317","ingredient":"GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE","trade_name":"PREVDUO","family_id":"","publication_number":"US11110054B2","cleaned_patent_number":"11110054","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-10-25","publication_date":"2021-09-07","legal_status":"Granted"} US11110054B2 Formulation 07 Sep, 2021 Granted 25 Oct, 2038

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.