NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as JANSSEN BIOTECH. It is marketed under 1 brand name, including LAZCLUZE. Available in 2 different strengths, such as EQ 80MG BASE, EQ 240MG 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":"130731","ingredient":"LAZERTINIB MESYLATE","trade_name":"LAZCLUZE","family_id":"","publication_number":"US9593098B2","cleaned_patent_number":"9593098","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-10-13","publication_date":"2017-03-14","legal_status":"Granted"} | US9593098B2 Molecular Formulation | 14 Mar, 2017 | Granted | 13 Oct, 2035 | |
| {"application_id":"130735","ingredient":"LAZERTINIB MESYLATE","trade_name":"LAZCLUZE","family_id":"","publication_number":"US11453656B2","cleaned_patent_number":"11453656","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-04-18","publication_date":"2022-09-27","legal_status":"Granted"} | US11453656B2 Molecular Formulation | 27 Sep, 2022 | Granted | 18 Apr, 2038 | |
| {"application_id":"130732","ingredient":"LAZERTINIB MESYLATE","trade_name":"LAZCLUZE","family_id":"","publication_number":"US11981659B2","cleaned_patent_number":"11981659","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-04-18","publication_date":"2024-05-14","legal_status":"Granted"} | US11981659B2 | 14 May, 2024 | Granted | 18 Apr, 2038 | |
| {"application_id":"130734","ingredient":"LAZERTINIB MESYLATE","trade_name":"LAZCLUZE","family_id":"","publication_number":"US11879013B2","cleaned_patent_number":"11879013","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-05-21","publication_date":"2024-01-23","legal_status":"Granted"} | US11879013B2 | 23 Jan, 2024 | Granted | 21 May, 2040 | |
| {"application_id":"164478","ingredient":"LAZERTINIB MESYLATE","trade_name":"LAZCLUZE","family_id":"","publication_number":"US12138351B2","cleaned_patent_number":"12138351","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-04-13","publication_date":"2024-11-12","legal_status":"Granted"} | US12138351B2 Formulation | 12 Nov, 2024 | Granted | 13 Apr, 2041 | |
| {"application_id":"130733","ingredient":"LAZERTINIB MESYLATE","trade_name":"LAZCLUZE","family_id":"","publication_number":"US11850248B2","cleaned_patent_number":"11850248","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-08-01","publication_date":"2023-12-26","legal_status":"Granted"} | US11850248B2 | 26 Dec, 2023 | Granted | 01 Aug, 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.