NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as AMNEAL. It is marketed under 1 brand name, including ONGENTYS. Available in 2 different strengths, such as 25MG, 50MG, and administered through 1 route including CAPSULE;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 |
|---|
Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"49850","ingredient":"OPICAPONE","trade_name":"ONGENTYS","family_id":"99f82a1e0efb48a3be3c","publication_number":"US9550759B2","cleaned_patent_number":"9550759","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-26","publication_date":"2017-01-24","legal_status":"Granted"} | US9550759B2 | 24 Jan, 2017 | Granted | 26 Jul, 2026 | |
| {"application_id":"49883","ingredient":"OPICAPONE","trade_name":"ONGENTYS","family_id":"99f82a1e0efb48a3be3c","publication_number":"US8907099B2","cleaned_patent_number":"8907099","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-12","publication_date":"2014-12-09","legal_status":"Granted"} | US8907099B2 Molecular | 09 Dec, 2014 | Granted | 12 May, 2027 | |
| {"application_id":"49891","ingredient":"OPICAPONE","trade_name":"ONGENTYS","family_id":"c8df182f5688414db505","publication_number":"US9745290B2","cleaned_patent_number":"9745290","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-10-10","publication_date":"2017-08-29","legal_status":"Granted"} | US9745290B2 Formulation | 29 Aug, 2017 | Granted | 10 Oct, 2027 | |
| {"application_id":"49882","ingredient":"OPICAPONE","trade_name":"ONGENTYS","family_id":"99f82a1e0efb48a3be3c","publication_number":"US8168793B2","cleaned_patent_number":"8168793","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-04-02","publication_date":"2012-05-01","legal_status":"Granted"} | US8168793B2 Molecular Formulation | 01 May, 2012 | Granted | 02 Apr, 2029 | |
| {"application_id":"49918","ingredient":"OPICAPONE","trade_name":"ONGENTYS","family_id":"c8df182f5688414db505","publication_number":"US8524746B2","cleaned_patent_number":"8524746","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-07-14","publication_date":"2013-09-03","legal_status":"Granted"} | US8524746B2 | 03 Sep, 2013 | Granted | 14 Jul, 2029 | |
| {"application_id":"49970","ingredient":"OPICAPONE","trade_name":"ONGENTYS","family_id":"25f309dee6584da49f7d","publication_number":"US10071085B2","cleaned_patent_number":"10071085","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-03-31","publication_date":"2018-09-11","legal_status":"Granted"} | US10071085B2 Formulation | 11 Sep, 2018 | Granted | 31 Mar, 2030 | |
| {"application_id":"49948","ingredient":"OPICAPONE","trade_name":"ONGENTYS","family_id":"25f309dee6584da49f7d","publication_number":"US10583130B2","cleaned_patent_number":"10583130","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-03-31","publication_date":"2020-03-10","legal_status":"Granted"} | US10583130B2 | 10 Mar, 2020 | Granted | 31 Mar, 2030 | |
| {"application_id":"138441","ingredient":"OPICAPONE","trade_name":"ONGENTYS","family_id":"","publication_number":"US12129247B2","cleaned_patent_number":"12129247","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-01-11","publication_date":"2024-10-29","legal_status":"Granted"} | US12129247B2 | 29 Oct, 2024 | Granted | 11 Jan, 2032 | |
| {"application_id":"49924","ingredient":"OPICAPONE","trade_name":"ONGENTYS","family_id":"e977fbde18cf40de9f78","publication_number":"US9630955B2","cleaned_patent_number":"9630955","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-12-12","publication_date":"2017-04-25","legal_status":"Granted"} | US9630955B2 Molecular Formulation | 25 Apr, 2017 | Granted | 12 Dec, 2032 |
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.