NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 2 pharmaceutical companies such as BAYER HLTHCARE, MSN. It is marketed under 2 brand names, including ADEMPAS, RIOCIGUAT. Available in 5 different strengths, such as 0.5MG, 1MG, 1.5MG and others, 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":"2017","ingredient":"RIOCIGUAT","trade_name":"ADEMPAS","family_id":"8bbe161b716b43b9abb0","publication_number":"US7173037B2","cleaned_patent_number":"7173037","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-04","publication_date":"2007-02-06","legal_status":"Expired"} | US7173037B2 Molecular Formulation | 06 Feb, 2007 | Expired | 04 Dec, 2026 | |
| {"application_id":"34893","ingredient":"RIOCIGUAT","trade_name":"ADEMPAS","family_id":"162409c26de446cc8913","publication_number":"US10662188B2","cleaned_patent_number":"10662188","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-02-18","publication_date":"2020-05-26","legal_status":"Granted"} | US10662188B2 Molecular Formulation | 26 May, 2020 | Granted | 18 Feb, 2034 | |
| {"application_id":"2019","ingredient":"RIOCIGUAT","trade_name":"ADEMPAS","family_id":"162409c26de446cc8913","publication_number":"US11203593B2","cleaned_patent_number":"11203593","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-02-18","publication_date":"2021-12-21","legal_status":"Granted"} | US11203593B2 Molecular Formulation | 21 Dec, 2021 | Granted | 18 Feb, 2034 |
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.