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 NOVARTIS. It is marketed under 1 brand name, including KISQALI FEMARA CO-PACK (COPACKAGED). Available in 1 different strength, such as 2.5MG;EQ 200MG BASE, and administered through 1 route including 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 |
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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":"95380","ingredient":"LETROZOLE; RIBOCICLIB SUCCINATE","trade_name":"KISQALI FEMARA CO-PACK (COPACKAGED)","family_id":"3691f13a1e0e4ef3889c","publication_number":"US8324225B2","cleaned_patent_number":"8324225","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-06-17","publication_date":"2012-12-04","legal_status":"Granted"} | US8324225B2 Molecular Formulation | 04 Dec, 2012 | Granted | 17 Jun, 2028 | |
| {"application_id":"95324","ingredient":"LETROZOLE; RIBOCICLIB SUCCINATE","trade_name":"KISQALI FEMARA CO-PACK (COPACKAGED)","family_id":"67d46f11f2b54407adcf","publication_number":"US9416136B2","cleaned_patent_number":"9416136","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-08-20","publication_date":"2016-08-16","legal_status":"Granted"} | US9416136B2 | 16 Aug, 2016 | Granted | 20 Aug, 2029 | |
| {"application_id":"95272","ingredient":"LETROZOLE; RIBOCICLIB SUCCINATE","trade_name":"KISQALI FEMARA CO-PACK (COPACKAGED)","family_id":"67d46f11f2b54407adcf","publication_number":"US8962630B2","cleaned_patent_number":"8962630","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-12-09","publication_date":"2015-02-24","legal_status":"Granted"} | US8962630B2 | 24 Feb, 2015 | Granted | 09 Dec, 2029 | |
| {"application_id":"95323","ingredient":"LETROZOLE; RIBOCICLIB SUCCINATE","trade_name":"KISQALI FEMARA CO-PACK (COPACKAGED)","family_id":"67d46f11f2b54407adcf","publication_number":"US8685980B2","cleaned_patent_number":"8685980","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-05-25","publication_date":"2014-04-01","legal_status":"Patented case"} | US8685980B2 Molecular Formulation | 01 Apr, 2014 | Patented case | 25 May, 2030 | |
| {"application_id":"95322","ingredient":"LETROZOLE; RIBOCICLIB SUCCINATE","trade_name":"KISQALI FEMARA CO-PACK (COPACKAGED)","family_id":"67d46f11f2b54407adcf","publication_number":"US8415355B2","cleaned_patent_number":"8415355","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-13","publication_date":"2013-04-09","legal_status":"Granted"} | US8415355B2 Molecular Formulation | 09 Apr, 2013 | Granted | 13 Mar, 2031 | |
| {"application_id":"95334","ingredient":"LETROZOLE; RIBOCICLIB SUCCINATE","trade_name":"KISQALI FEMARA CO-PACK (COPACKAGED)","family_id":"04b9fb87d1d84462a2d8","publication_number":"US9868739B2","cleaned_patent_number":"9868739","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-11-09","publication_date":"2018-01-16","legal_status":"Granted"} | US9868739B2 | 16 Jan, 2018 | Granted | 09 Nov, 2031 | |
| {"application_id":"95373","ingredient":"LETROZOLE; RIBOCICLIB SUCCINATE","trade_name":"KISQALI FEMARA CO-PACK (COPACKAGED)","family_id":"04b9fb87d1d84462a2d8","publication_number":"US9193732B2","cleaned_patent_number":"9193732","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-11-09","publication_date":"2015-11-24","legal_status":"Granted"} | US9193732B2 Molecular Formulation | 24 Nov, 2015 | Granted | 09 Nov, 2031 | |
| {"application_id":"130729","ingredient":"LETROZOLE; RIBOCICLIB SUCCINATE","trade_name":"KISQALI FEMARA CO-PACK (COPACKAGED)","family_id":"","publication_number":"US12064434B2","cleaned_patent_number":"12064434","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-04-14","publication_date":"2024-08-20","legal_status":"Granted"} | US12064434B2 Formulation | 20 Aug, 2024 | Granted | 14 Apr, 2036 | |
| {"application_id":"95423","ingredient":"LETROZOLE; RIBOCICLIB SUCCINATE","trade_name":"KISQALI FEMARA CO-PACK (COPACKAGED)","family_id":"5a0062b941284f229588","publication_number":"US10799506B2","cleaned_patent_number":"10799506","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-04-14","publication_date":"2020-10-13","legal_status":"Granted"} | US10799506B2 Formulation | 13 Oct, 2020 | Granted | 14 Apr, 2036 |
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 Letrozole; Ribociclib Succinate
Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.