NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as IDORSIA. It is marketed under 1 brand name, including TRYVIO. Available in 1 different strength, such as 12.5MG, and administered through 1 route including TABLET;ORAL.
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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":"123321","ingredient":"APROCITENTAN","trade_name":"TRYVIO","family_id":"","publication_number":"US8324232B2","cleaned_patent_number":"8324232","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-21","publication_date":"2012-12-04","legal_status":"Granted"} | US8324232B2 Molecular Formulation | 04 Dec, 2012 | Granted | 21 Sep, 2029 | |
| {"application_id":"28085","ingredient":"APROCITENTAN","trade_name":"TRYVIO","family_id":"46345a94b5534e1085e3","publication_number":"US11174247B2","cleaned_patent_number":"11174247","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-11-06","publication_date":"2021-11-16","legal_status":"Granted"} | US11174247B2 | 16 Nov, 2021 | Granted | 06 Nov, 2037 | |
| {"application_id":"28084","ingredient":"APROCITENTAN","trade_name":"TRYVIO","family_id":"46345a94b5534e1085e3","publication_number":"US10919881B2","cleaned_patent_number":"10919881","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-02-26","publication_date":"2021-02-16","legal_status":"Granted"} | US10919881B2 Molecular Formulation | 16 Feb, 2021 | Granted | 26 Feb, 2038 | |
| {"application_id":"242162","ingredient":"APROCITENTAN","trade_name":"TRYVIO","family_id":"","publication_number":"US12297189B2","cleaned_patent_number":"12297189","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-02-26","publication_date":"2025-05-13","legal_status":"Granted"} | US12297189B2 Formulation | 13 May, 2025 | Granted | 26 Feb, 2038 | |
| {"application_id":"28088","ingredient":"APROCITENTAN","trade_name":"TRYVIO","family_id":"46345a94b5534e1085e3","publication_number":"US11787782B2","cleaned_patent_number":"11787782","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-03-02","publication_date":"2023-10-17","legal_status":"Granted"} | US11787782B2 | 17 Oct, 2023 | Granted | 02 Mar, 2038 | |
| {"application_id":"28086","ingredient":"APROCITENTAN","trade_name":"TRYVIO","family_id":"46345a94b5534e1085e3","publication_number":"US11680058B2","cleaned_patent_number":"11680058","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-07-26","publication_date":"2023-06-20","legal_status":"Granted"} | US11680058B2 | 20 Jun, 2023 | Granted | 26 Jul, 2038 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
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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.