NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as GENENTECH INC. It is marketed under 1 brand name, including EVRYSDI. Available in 2 different strengths, such as 0.75MG/ML, 5MG, and administered through 2 routes including FOR SOLUTION;ORAL, 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 |
|---|
Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"57015","ingredient":"RISDIPLAM","trade_name":"EVRYSDI","family_id":"c7df6082d9274fc6b208","publication_number":"US9586955B2","cleaned_patent_number":"9586955","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-02-08","publication_date":"2017-03-07","legal_status":"Granted"} | US9586955B2 Molecular Formulation | 07 Mar, 2017 | Granted | 08 Feb, 2033 | |
| {"application_id":"56972","ingredient":"RISDIPLAM","trade_name":"EVRYSDI","family_id":"3a73ecce40fe4f50b96d","publication_number":"US9969754B2","cleaned_patent_number":"9969754","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-05-11","publication_date":"2018-05-15","legal_status":"Granted"} | US9969754B2 Molecular Formulation | 15 May, 2018 | Granted | 11 May, 2035 | |
| {"application_id":"57011","ingredient":"RISDIPLAM","trade_name":"EVRYSDI","family_id":"3a73ecce40fe4f50b96d","publication_number":"US11827646B2","cleaned_patent_number":"11827646","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-01-25","publication_date":"2023-11-28","legal_status":"Granted"} | US11827646B2 | 28 Nov, 2023 | Granted | 25 Jan, 2036 | |
| {"application_id":"123143","ingredient":"RISDIPLAM","trade_name":"EVRYSDI","family_id":"2ecef10a209c4dc5b427","publication_number":"US11938136B2","cleaned_patent_number":"11938136","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-11-08","publication_date":"2024-03-26","legal_status":"Granted"} | US11938136B2 Formulation | 26 Mar, 2024 | Granted | 08 Nov, 2036 | |
| {"application_id":"111301","ingredient":"RISDIPLAM","trade_name":"EVRYSDI","family_id":"f345d927365a48c19dfa","publication_number":"US11534444B2","cleaned_patent_number":"11534444","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-10-04","publication_date":"2022-12-27","legal_status":"Granted"} | US11534444B2 | 27 Dec, 2022 | Granted | 04 Oct, 2038 | |
| {"application_id":"138453","ingredient":"RISDIPLAM","trade_name":"EVRYSDI","family_id":"","publication_number":"US12122789B2","cleaned_patent_number":"12122789","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-04-15","publication_date":"2024-10-22","legal_status":"Granted"} | US12122789B2 Molecular Formulation | 22 Oct, 2024 | Granted | 15 Apr, 2041 |
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.