NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 34 pharmaceutical companies such as TEVA PHARMS USA, NORVIUM BIOSCIENCE, HETERO LABS LTD III and others. It is marketed under 7 brand names, including TADALAFIL, ALYQ, ENTADFI and others. Available in 8 different strengths, such as 10MG, 5MG, 2.5MG and others, and administered through 4 routes including TABLET;ORAL, CAPSULE;ORAL, SUSPENSION;ORAL and others.
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Licensing: 34 potential partnersUS Launch window: Loading launch window...
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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":"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":"Patented case"} | US8268847B2 Formulation | 18 Sep, 2012 | Patented case | 18 Apr, 2029 | |
| {"application_id":"139405","ingredient":"TADALAFIL","trade_name":"TADLIQ","family_id":"79f502b554734a40bd75","publication_number":"US12186322B2","cleaned_patent_number":"12186322","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-12-24","publication_date":"2025-01-07","legal_status":"Granted"} | US12186322B2 Formulation | 07 Jan, 2025 | Granted | 24 Dec, 2038 | |
| {"application_id":"116358","ingredient":"TADALAFIL","trade_name":"TADLIQ","family_id":"79f502b554734a40bd75","publication_number":"US11975006B2","cleaned_patent_number":"11975006","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-12-24","publication_date":"2024-05-07","legal_status":"Granted"} | US11975006B2 Formulation | 07 May, 2024 | Granted | 24 Dec, 2038 | |
| {"application_id":"83191","ingredient":"TADALAFIL","trade_name":"TADLIQ","family_id":"79f502b554734a40bd75","publication_number":"US11382917B2","cleaned_patent_number":"11382917","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-12-24","publication_date":"2022-07-12","legal_status":"Granted"} | US11382917B2 Formulation | 12 Jul, 2022 | Granted | 24 Dec, 2038 | |
| {"application_id":"116356","ingredient":"TADALAFIL","trade_name":"TADLIQ","family_id":"79f502b554734a40bd75","publication_number":"US11666576B2","cleaned_patent_number":"11666576","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-12-24","publication_date":"2023-06-06","legal_status":"Granted"} | US11666576B2 Formulation | 06 Jun, 2023 | Granted | 24 Dec, 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.