NDA (New Drug Application)
ANDA (Generic Application)
Track protection status across key markets to assess launch feasibility.
It is formulated by 1 pharmaceutical company such as ACTELION. It is marketed under 1 brand name, including OPSYNVI. Available in 2 different strengths, such as 10MG;20MG, 10MG;40MG, and administered through 1 route including TABLET;ORAL.
API availability: Loading API feasibility...
Licensing: 1 potential partnersUS Launch window: Loading launch window...
Stay ahead with worldwide patent expiry and latest updates.
FDA approval history for this ingredient
Stay ahead with worldwide patent expiry insights, exclusivity data, and latest updates.
Key expiration dates for US patents covering this ingredient
Stay ahead with worldwide patent expiry insights, market data, and research updates.
Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
|---|
Patents approved by the FDA for the ingredient
|
|
Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"97432","ingredient":"MACITENTAN; TADALAFIL","trade_name":"OPSYNVI","family_id":"8df2aa509a8c4a70b0d2","publication_number":"US7094781B2","cleaned_patent_number":"7094781","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-12-05","publication_date":"2006-08-22","legal_status":"Court proceedings terminated"} | US7094781B2 Molecular Formulation | 22 Aug, 2006 | Court proceedings terminated | 05 Dec, 2025 | |
| {"application_id":"97425","ingredient":"MACITENTAN; TADALAFIL","trade_name":"OPSYNVI","family_id":"41d3707b741c4921b6d2","publication_number":"US10946015B2","cleaned_patent_number":"10946015","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-09-11","publication_date":"2021-03-16","legal_status":"Patented case"} | US10946015B2 Formulation | 16 Mar, 2021 | Patented case | 11 Sep, 2026 | |
| {"application_id":"97361","ingredient":"MACITENTAN; TADALAFIL","trade_name":"OPSYNVI","family_id":"41042dc61aee41c2a345","publication_number":"US8268847B2","cleaned_patent_number":"8268847","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-04-18","publication_date":"2012-09-18","legal_status":"Granted"} | US8268847B2 Formulation | 18 Sep, 2012 | Granted | 18 Apr, 2029 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
Manufacturing Locations
Unlock access to all suppliers of Macitentan; Tadalafil
Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.