NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as ASTRAZENECA. It is marketed under 1 brand name, including TAGRISSO. Available in 2 different strengths, such as EQ 40MG BASE, EQ 80MG 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":"100326","ingredient":"OSIMERTINIB MESYLATE","trade_name":"TAGRISSO","family_id":"205aa5c585c8403e851a","publication_number":"US11524951B2","cleaned_patent_number":"11524951","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-07-25","publication_date":"2022-12-13","legal_status":"Granted"} | US11524951B2 Molecular Formulation | 13 Dec, 2022 | Granted | 25 Jul, 2032 | |
| {"application_id":"100208","ingredient":"OSIMERTINIB MESYLATE","trade_name":"TAGRISSO","family_id":"32496cacc95c4fdaa7dd","publication_number":"US9732058B2","cleaned_patent_number":"9732058","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-07-25","publication_date":"2017-08-15","legal_status":"Granted"} | US9732058B2 Molecular Formulation | 15 Aug, 2017 | Granted | 25 Jul, 2032 | |
| {"application_id":"100322","ingredient":"OSIMERTINIB MESYLATE","trade_name":"TAGRISSO","family_id":"32496cacc95c4fdaa7dd","publication_number":"US8946235B2","cleaned_patent_number":"8946235","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-08-08","publication_date":"2015-02-03","legal_status":"Granted"} | US8946235B2 Molecular Formulation | 03 Feb, 2015 | Granted | 08 Aug, 2032 | |
| {"application_id":"7167","ingredient":"OSIMERTINIB MESYLATE","trade_name":"TAGRISSO","family_id":"fcc9e2b8e2e74109bb70","publication_number":"US10183020B2","cleaned_patent_number":"10183020","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-01-02","publication_date":"2019-01-22","legal_status":"Granted"} | US10183020B2 Formulation | 22 Jan, 2019 | Granted | 02 Jan, 2035 |
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.