NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 15 pharmaceutical companies such as PF PRISM CV, ZYDUS PHARMS, DR REDDYS and others. It is marketed under 5 brand names, including RAPAMUNE, SIROLIMUS, TEMSIROLIMUS and others. Available in 7 different strengths, such as 0.5MG, 1MG, 2MG and others, and administered through 5 routes including TABLET;ORAL, SOLUTION;INTRAVENOUS, SOLUTION;ORAL and others.
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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":"75055","ingredient":"TEMSIROLIMUS","trade_name":"TORISEL","family_id":"9cb0facde7ea421e907f","publication_number":"US8026276B2","cleaned_patent_number":"8026276","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-20","publication_date":"2011-09-27","legal_status":"Granted"} | US8026276B2 | 27 Sep, 2011 | Granted | 20 Jul, 2026 | |
| {"application_id":"67011","ingredient":"SIROLIMUS","trade_name":"FYARRO","family_id":"5e4f414480b742b39441","publication_number":"US8911786B2","cleaned_patent_number":"8911786","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-14","publication_date":"2014-12-16","legal_status":"Granted"} | US8911786B2 Formulation | 16 Dec, 2014 | Granted | 14 Feb, 2029 | |
| {"application_id":"67092","ingredient":"SIROLIMUS","trade_name":"FYARRO","family_id":"84cda2f3c236456ea6e7","publication_number":"US10206887B2","cleaned_patent_number":"10206887","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-04-15","publication_date":"2019-02-19","legal_status":"Granted"} | US10206887B2 Formulation | 19 Feb, 2019 | Granted | 15 Apr, 2030 | |
| {"application_id":"75090","ingredient":"TEMSIROLIMUS","trade_name":"TORISEL","family_id":"7bc01adc44ef4e08b0e7","publication_number":"US8791097B2","cleaned_patent_number":"8791097","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-10","publication_date":"2014-07-29","legal_status":"Granted"} | US8791097B2 | 29 Jul, 2014 | Granted | 10 Nov, 2032 | |
| {"application_id":"130701","ingredient":"SIROLIMUS","trade_name":"FYARRO","family_id":"","publication_number":"US12061183B2","cleaned_patent_number":"12061183","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-03-05","publication_date":"2024-08-13","legal_status":"Granted"} | US12061183B2 Formulation | 13 Aug, 2024 | Granted | 05 Mar, 2036 | |
| {"application_id":"67123","ingredient":"SIROLIMUS","trade_name":"FYARRO","family_id":"0c97fd36ed714e14b049","publication_number":"US10705070B1","cleaned_patent_number":"10705070","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-03-05","publication_date":"2020-07-07","legal_status":"Granted"} | US10705070B2 Formulation | 07 Jul, 2020 | Granted | 05 Mar, 2036 | |
| {"application_id":"67006","ingredient":"SIROLIMUS","trade_name":"FYARRO","family_id":"66a11475f72d42e18717","publication_number":"US20210322391A1","cleaned_patent_number":"12133844","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-06-29","publication_date":"2021-10-21","legal_status":"Pending"} | US12133844B2 | 21 Oct, 2021 | Pending | 29 Jun, 2036 | |
| {"application_id":"66979","ingredient":"SIROLIMUS","trade_name":"FYARRO","family_id":"66a11475f72d42e18717","publication_number":"US10973806B2","cleaned_patent_number":"10973806","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-06-29","publication_date":"2021-04-13","legal_status":"Granted"} | US10973806B2 | 13 Apr, 2021 | Granted | 29 Jun, 2036 | |
| {"application_id":"109361","ingredient":"SIROLIMUS","trade_name":"FYARRO","family_id":"","publication_number":"US11497737B2","cleaned_patent_number":"11497737","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-10-28","publication_date":"2022-11-15","legal_status":"Granted"} | US11497737B2 Formulation | 15 Nov, 2022 | Granted | 28 Oct, 2040 |
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.