Olanzapine Global Patent Coverage & Expiry Overview

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It is formulated by 35 pharmaceutical companies such as TEVA PHARMS, STRIDES PHARMA, DR REDDYS LABS LTD and others. It is marketed under 3 brand names, including OLANZAPINE, OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, LYBALVI. Available in 16 different strengths, such as 2.5MG, 5MG, 20MG and others, and administered through 4 routes including TABLET;ORAL, TABLET, ORALLY DISINTEGRATING;ORAL, INJECTABLE;INTRAMUSCULAR and others.

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Sourcing & Feasibility

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

NDA (New Drug Application) ANDA (Generic Application)

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US Orange Book Patents Expiration Timeline

Key expiration dates for US patents covering this ingredient

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Orange Book Drug Strengths

Latest drug strengths approved by FDA

Strength Route of Administration Companies Latest Approval Date

Orange Book Patents

Patents approved by the FDA for the ingredient

Patent Number Publication Date Legal Status Patent Expiry Date
{"application_id":"1843","ingredient":"OLANZAPINE; SAMIDORPHAN L-MALATE","trade_name":"LYBALVI","family_id":"c113a6e3256f49d98f74","publication_number":"US7262298B2","cleaned_patent_number":"7262298","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-11-23","publication_date":"2007-08-28","legal_status":"Granted"} US7262298B2 Molecular 28 Aug, 2007 Granted 23 Nov, 2025
{"application_id":"34946","ingredient":"OLANZAPINE; SAMIDORPHAN L-MALATE","trade_name":"LYBALVI","family_id":"6d388f4a710145c089c7","publication_number":"US10716785B2","cleaned_patent_number":"10716785","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-23","publication_date":"2020-07-21","legal_status":"Granted"} US10716785B2 21 Jul, 2020 Granted 23 Aug, 2031
{"application_id":"34947","ingredient":"OLANZAPINE; SAMIDORPHAN L-MALATE","trade_name":"LYBALVI","family_id":"6d388f4a710145c089c7","publication_number":"US11185541B2","cleaned_patent_number":"11185541","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-23","publication_date":"2021-11-30","legal_status":"Granted"} US11185541B2 30 Nov, 2021 Granted 23 Aug, 2031
{"application_id":"34948","ingredient":"OLANZAPINE; SAMIDORPHAN L-MALATE","trade_name":"LYBALVI","family_id":"6d388f4a710145c089c7","publication_number":"US11241425B2","cleaned_patent_number":"11241425","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-23","publication_date":"2022-02-08","legal_status":"Granted"} US11241425B2 08 Feb, 2022 Granted 23 Aug, 2031
{"application_id":"21204","ingredient":"OLANZAPINE; SAMIDORPHAN L-MALATE","trade_name":"LYBALVI","family_id":"6d388f4a710145c089c7","publication_number":"US11351166B2","cleaned_patent_number":"11351166","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-23","publication_date":"2022-06-07","legal_status":"Patented case"} US11351166B2 07 Jun, 2022 Patented case 23 Aug, 2031
{"application_id":"105172","ingredient":"OLANZAPINE; SAMIDORPHAN L-MALATE","trade_name":"LYBALVI","family_id":"6d388f4a710145c089c7","publication_number":"US11793805B2","cleaned_patent_number":"11793805","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-23","publication_date":"2023-10-24","legal_status":"Granted"} US11793805B2 24 Oct, 2023 Granted 23 Aug, 2031
{"application_id":"34945","ingredient":"OLANZAPINE; SAMIDORPHAN L-MALATE","trade_name":"LYBALVI","family_id":"6d388f4a710145c089c7","publication_number":"US10300054B2","cleaned_patent_number":"10300054","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-23","publication_date":"2019-05-28","legal_status":"Patented case"} US10300054B2 Formulation 28 May, 2019 Patented case 23 Aug, 2031
{"application_id":"139432","ingredient":"OLANZAPINE; SAMIDORPHAN L-MALATE","trade_name":"LYBALVI","family_id":"6d388f4a710145c089c7","publication_number":"US12194035B2","cleaned_patent_number":"12194035","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-23","publication_date":"2025-01-14","legal_status":"Granted"} US12194035B2 14 Jan, 2025 Granted 23 Aug, 2031
{"application_id":"1846","ingredient":"OLANZAPINE; SAMIDORPHAN L-MALATE","trade_name":"LYBALVI","family_id":"6d388f4a710145c089c7","publication_number":"US9126977B2","cleaned_patent_number":"9126977","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-23","publication_date":"2015-09-08","legal_status":"Granted"} US9126977B2 Formulation 08 Sep, 2015 Granted 23 Aug, 2031
{"application_id":"1847","ingredient":"OLANZAPINE; SAMIDORPHAN L-MALATE","trade_name":"LYBALVI","family_id":"6d388f4a710145c089c7","publication_number":"US9517235B2","cleaned_patent_number":"9517235","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-23","publication_date":"2016-12-13","legal_status":"Granted"} US9517235B2 13 Dec, 2016 Granted 23 Aug, 2031
{"application_id":"1845","ingredient":"OLANZAPINE; SAMIDORPHAN L-MALATE","trade_name":"LYBALVI","family_id":"22616693c69f43e682c7","publication_number":"US9119848B2","cleaned_patent_number":"9119848","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-30","publication_date":"2015-09-01","legal_status":"Granted"} US9119848B2 Molecular 01 Sep, 2015 Granted 30 Aug, 2031
{"application_id":"34942","ingredient":"OLANZAPINE; SAMIDORPHAN L-MALATE","trade_name":"LYBALVI","family_id":"6d388f4a710145c089c7","publication_number":"US8778960B2","cleaned_patent_number":"8778960","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-02-13","publication_date":"2014-07-15","legal_status":"Granted"} US8778960B2 15 Jul, 2014 Granted 13 Feb, 2032
{"application_id":"116645","ingredient":"OLANZAPINE; SAMIDORPHAN L-MALATE","trade_name":"LYBALVI","family_id":"53a8192342d043559b49","publication_number":"US11951111B2","cleaned_patent_number":"11951111","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-11-12","publication_date":"2024-04-09","legal_status":"Granted"} US11951111B2 09 Apr, 2024 Granted 12 Nov, 2041
{"application_id":"116643","ingredient":"OLANZAPINE; SAMIDORPHAN L-MALATE","trade_name":"LYBALVI","family_id":"53a8192342d043559b49","publication_number":"US11707466B2","cleaned_patent_number":"11707466","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-11-12","publication_date":"2023-07-25","legal_status":"Patented case"} US11707466B2 Formulation 25 Jul, 2023 Patented case 12 Nov, 2041

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

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API Suppliers/Manufacturer (Branded/Generic companies)

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.

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