NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 20 pharmaceutical companies such as SUNOVION PHARMS INC, ACCORD HLTHCARE, AMNEAL PHARMS CO and others. It is marketed under 2 brand names, including LATUDA, LURASIDONE HYDROCHLORIDE. Available in 5 different strengths, such as 80MG, 40MG, 20MG and others, 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":"95617","ingredient":"LURASIDONE HYDROCHLORIDE","trade_name":"LATUDA","family_id":"cd644a18cf754fc981ca","publication_number":"USRE45573E1","cleaned_patent_number":"RE45573","drug_product_flag":"-","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-12-23","publication_date":"2015-06-23","legal_status":"Patented case"} | USRE45573E1 | 23 Jun, 2015 | Patented case | 23 Dec, 2025 | |
| {"application_id":"95582","ingredient":"LURASIDONE HYDROCHLORIDE","trade_name":"LATUDA","family_id":"af1a0c1c910146e487ca","publication_number":"US9555027B2","cleaned_patent_number":"9555027","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-05-26","publication_date":"2017-01-31","legal_status":"Patented case"} | US9555027B2 Formulation | 31 Jan, 2017 | Patented case | 26 May, 2026 | |
| {"application_id":"95609","ingredient":"LURASIDONE HYDROCHLORIDE","trade_name":"LATUDA","family_id":"af1a0c1c910146e487ca","publication_number":"US8729085B2","cleaned_patent_number":"8729085","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-26","publication_date":"2014-05-20","legal_status":"Granted"} | US8729085B2 | 20 May, 2014 | Granted | 26 Nov, 2026 | |
| {"application_id":"95611","ingredient":"LURASIDONE HYDROCHLORIDE","trade_name":"LATUDA","family_id":"af1a0c1c910146e487ca","publication_number":"US9907794B2","cleaned_patent_number":"9907794","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-26","publication_date":"2018-03-06","legal_status":"Granted"} | US9907794B2 | 06 Mar, 2018 | Granted | 26 Nov, 2026 | |
| {"application_id":"95610","ingredient":"LURASIDONE HYDROCHLORIDE","trade_name":"LATUDA","family_id":"af1a0c1c910146e487ca","publication_number":"US8883794B2","cleaned_patent_number":"8883794","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-26","publication_date":"2014-11-11","legal_status":"Granted"} | US8883794B2 | 11 Nov, 2014 | Granted | 26 Nov, 2026 | |
| {"application_id":"95562","ingredient":"LURASIDONE HYDROCHLORIDE","trade_name":"LATUDA","family_id":"4957c99797714eeb8195","publication_number":"US9827242B2","cleaned_patent_number":"9827242","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-05-23","publication_date":"2017-11-28","legal_status":"Granted"} | US9827242B2 | 28 Nov, 2017 | Granted | 23 May, 2031 | |
| {"application_id":"95555","ingredient":"LURASIDONE HYDROCHLORIDE","trade_name":"LATUDA","family_id":"4957c99797714eeb8195","publication_number":"US9259423B2","cleaned_patent_number":"9259423","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-11-23","publication_date":"2016-02-16","legal_status":"Granted"} | US9259423B2 | 16 Feb, 2016 | Granted | 23 Nov, 2031 |
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.