NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 2 pharmaceutical companies such as BOEHRINGER INGELHEIM, LUPIN. It is marketed under 3 brand names, including SPIRIVA RESPIMAT, STIOLTO RESPIMAT, TIOTROPIUM BROMIDE. Available in 4 different strengths, such as EQ 0.0025MG BASE/INH, EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH, EQ 0.00125MG BASE/INH and others, and administered through 2 routes including SPRAY, METERED;INHALATION, POWDER;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":"80845","ingredient":"OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE","trade_name":"SPIRIVA RESPIMAT","family_id":"35a9e028cdbe405c8fe5","publication_number":"US7284474B2","cleaned_patent_number":"7284474","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-02-26","publication_date":"2007-10-23","legal_status":"Expired"} | US7284474B2 | 23 Oct, 2007 | Expired | 26 Feb, 2025 | |
| {"application_id":"80921","ingredient":"OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE","trade_name":"STIOLTO RESPIMAT","family_id":"41bb72de674c45f1a71b","publication_number":"US8034809B2","cleaned_patent_number":"8034809","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-05-12","publication_date":"2011-10-11","legal_status":"Granted"} | US8034809B2 | 11 Oct, 2011 | Granted | 12 May, 2025 | |
| {"application_id":"80898","ingredient":"OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE","trade_name":"STIOLTO RESPIMAT","family_id":"41bb72de674c45f1a71b","publication_number":"US7220742B2","cleaned_patent_number":"7220742","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-05-12","publication_date":"2007-05-22","legal_status":"Granted"} | US7220742B2 Molecular Formulation | 22 May, 2007 | Granted | 12 May, 2025 | |
| {"application_id":"65972","ingredient":"TIOTROPIUM BROMIDE","trade_name":"SPIRIVA","family_id":"4367c15edc064a27a237","publication_number":"US8022082B2","cleaned_patent_number":"8022082","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-19","publication_date":"2011-09-20","legal_status":"Granted"} | US8022082B2 | 20 Sep, 2011 | Granted | 19 Jul, 2026 | |
| {"application_id":"80967","ingredient":"OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE","trade_name":"STIOLTO RESPIMAT","family_id":"e42c5e7cc5d848d398db","publication_number":"US7727984B2","cleaned_patent_number":"7727984","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-19","publication_date":"2010-06-01","legal_status":"Expired"} | US7727984B2 Molecular | 01 Jun, 2010 | Expired | 19 Jan, 2027 | |
| {"application_id":"80814","ingredient":"OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE","trade_name":"SPIRIVA RESPIMAT","family_id":"f28f0dd9210c453e8c27","publication_number":"US7396341B2","cleaned_patent_number":"7396341","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-04-10","publication_date":"2008-07-08","legal_status":"Granted"} | US7396341B2 | 08 Jul, 2008 | Granted | 10 Apr, 2027 | |
| {"application_id":"80746","ingredient":"OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE","trade_name":"SPIRIVA RESPIMAT","family_id":"1a54511ec83b48d5a977","publication_number":"US9027967B2","cleaned_patent_number":"9027967","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-09-30","publication_date":"2015-05-12","legal_status":"Granted"} | US9027967B2 | 12 May, 2015 | Granted | 30 Sep, 2027 | |
| {"application_id":"80774","ingredient":"OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE","trade_name":"SPIRIVA RESPIMAT","family_id":"1a54511ec83b48d5a977","publication_number":"US7837235B2","cleaned_patent_number":"7837235","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-09-13","publication_date":"2010-11-23","legal_status":"Granted"} | US7837235B2 | 23 Nov, 2010 | Granted | 13 Sep, 2028 | |
| {"application_id":"80736","ingredient":"OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE","trade_name":"SPIRIVA RESPIMAT","family_id":"4a93c86f882540d4bb81","publication_number":"US8733341B2","cleaned_patent_number":"8733341","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-04-16","publication_date":"2014-05-27","legal_status":"Granted"} | US8733341B2 | 27 May, 2014 | Granted | 16 Apr, 2031 |
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.