NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as PFIZER. It is marketed under 1 brand name, including LORBRENA. Available in 2 different strengths, such as 25MG, 100MG, 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":"95987","ingredient":"LORLATINIB","trade_name":"LORBRENA","family_id":"b3db76abe3bd447eb5dd","publication_number":"US8680111B2","cleaned_patent_number":"8680111","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-05","publication_date":"2014-03-25","legal_status":"Granted"} | US8680111B2 Molecular Formulation | 25 Mar, 2014 | Granted | 05 Mar, 2033 | |
| {"application_id":"95961","ingredient":"LORLATINIB","trade_name":"LORBRENA","family_id":"7c18576a9d0e49688b34","publication_number":"US10420749B2","cleaned_patent_number":"10420749","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-07-27","publication_date":"2019-09-24","legal_status":"Granted"} | US10420749B2 Molecular Formulation | 24 Sep, 2019 | Granted | 27 Jul, 2036 | |
| {"application_id":"95982","ingredient":"LORLATINIB","trade_name":"LORBRENA","family_id":"7c18576a9d0e49688b34","publication_number":"US11020376B2","cleaned_patent_number":"11020376","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-07-27","publication_date":"2021-06-01","legal_status":"Granted"} | US11020376B2 Formulation | 01 Jun, 2021 | Granted | 27 Jul, 2036 | |
| {"application_id":"95945","ingredient":"LORLATINIB","trade_name":"LORBRENA","family_id":"97d54bb823964d1f86c0","publication_number":"US11299500B2","cleaned_patent_number":"11299500","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-10-04","publication_date":"2022-04-12","legal_status":"Granted"} | US11299500B2 Molecular | 12 Apr, 2022 | Granted | 04 Oct, 2038 |
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.