NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as PF PRISM CV. It is marketed under 1 brand name, including XALKORI. Available in 5 different strengths, such as 200MG, 250MG, 20MG and others, and administered through 2 routes including CAPSULE;ORAL, CAPSULE, PELLETS;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":"53775","ingredient":"CRIZOTINIB","trade_name":"XALKORI","family_id":"4fc527c689374f7b9243","publication_number":"US8785632B2","cleaned_patent_number":"8785632","drug_product_flag":"-, Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-03-01","publication_date":"2014-07-22","legal_status":"Patented case"} | US8785632B2 Molecular | 22 Jul, 2014 | Patented case | 01 Mar, 2025 | |
| {"application_id":"53782","ingredient":"CRIZOTINIB","trade_name":"XALKORI","family_id":"6ae4261b3dfd4bbfb472","publication_number":"US7230098B2","cleaned_patent_number":"7230098","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-08-26","publication_date":"2007-06-12","legal_status":"Granted"} | US7230098B2 Molecular | 12 Jun, 2007 | Granted | 26 Aug, 2025 | |
| {"application_id":"53704","ingredient":"CRIZOTINIB","trade_name":"XALKORI","family_id":"8632d17868cf49779d2d","publication_number":"US7825137B2","cleaned_patent_number":"7825137","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-12","publication_date":"2010-11-02","legal_status":"Granted"} | US7825137B2 | 02 Nov, 2010 | Granted | 12 May, 2027 | |
| {"application_id":"53731","ingredient":"CRIZOTINIB","trade_name":"XALKORI","family_id":"4fc527c689374f7b9243","publication_number":"US7858643B2","cleaned_patent_number":"7858643","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-10-08","publication_date":"2010-12-28","legal_status":"Granted"} | US7858643B2 Molecular Formulation | 28 Dec, 2010 | Granted | 08 Oct, 2029 | |
| {"application_id":"53825","ingredient":"CRIZOTINIB","trade_name":"XALKORI","family_id":"f9ae15df80824e14ba30","publication_number":"US8217057B2","cleaned_patent_number":"8217057","drug_product_flag":"-, Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-11-06","publication_date":"2012-07-10","legal_status":"Granted"} | US8217057B2 Molecular | 10 Jul, 2012 | Granted | 06 Nov, 2029 |
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.