NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 2 pharmaceutical companies such as ASTRAZENECA, ASTRAZENECA AB. It is marketed under 2 brand names, including BEVESPI AEROSPHERE, BREZTRI AEROSPHERE. Available in 2 different strengths, such as 0.0048MG/INH;0.0090MG/INH, 0.16MG/INH;0.0048MG/INH;0.009MG/INH, and administered through 1 route including AEROSOL, METERED;INHALATION.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
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Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"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":"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":"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":"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":"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":"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":"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":"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 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
Manufacturing Locations
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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.