Larotrectinib Sulfate Global Patent Coverage & Expiry Overview

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It is formulated by 2 pharmaceutical companies such as BAYER HLTHCARE, BAYER HEALTHCARE. It is marketed under 1 brand name, including VITRAKVI. Available in 3 different strengths, such as EQ 25MG BASE, EQ 100MG BASE, EQ 20MG BASE/ML, and administered through 2 routes including CAPSULE;ORAL, SOLUTION;ORAL.

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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":"52547","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"8283cb8afc514573a268","publication_number":"US10774085B2","cleaned_patent_number":"10774085","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-10-21","publication_date":"2020-09-15","legal_status":"Granted"} US10774085B2 15 Sep, 2020 Granted 21 Oct, 2029
{"application_id":"52545","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"8283cb8afc514573a268","publication_number":"US9676783B2","cleaned_patent_number":"9676783","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-10-21","publication_date":"2017-06-13","legal_status":"Granted"} US9676783B2 13 Jun, 2017 Granted 21 Oct, 2029
{"application_id":"52542","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"8283cb8afc514573a268","publication_number":"US8865698B2","cleaned_patent_number":"8865698","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-10-21","publication_date":"2014-10-21","legal_status":"Granted"} US8865698B2 21 Oct, 2014 Granted 21 Oct, 2029
{"application_id":"52543","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"8283cb8afc514573a268","publication_number":"US9127013B2","cleaned_patent_number":"9127013","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-10-21","publication_date":"2015-09-08","legal_status":"Granted"} US9127013B2 Molecular Formulation 08 Sep, 2015 Granted 21 Oct, 2029
{"application_id":"52546","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"8283cb8afc514573a268","publication_number":"US10005783B2","cleaned_patent_number":"10005783","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-10-21","publication_date":"2018-06-26","legal_status":"Patented case"} US10005783B2 26 Jun, 2018 Patented case 21 Oct, 2029
{"application_id":"52450","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"8283cb8afc514573a268","publication_number":"US10047097B2","cleaned_patent_number":"10047097","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-10-21","publication_date":"2018-08-14","legal_status":"Granted"} US10047097B2 14 Aug, 2018 Granted 21 Oct, 2029
{"application_id":"52544","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"8283cb8afc514573a268","publication_number":"US9447104B2","cleaned_patent_number":"9447104","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-10-21","publication_date":"2016-09-20","legal_status":"Granted"} US9447104B2 20 Sep, 2016 Granted 21 Oct, 2029
{"application_id":"52541","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"8283cb8afc514573a268","publication_number":"US8513263B2","cleaned_patent_number":"8513263","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-12-23","publication_date":"2013-08-20","legal_status":"Patented case"} US8513263B2 Molecular Formulation 20 Aug, 2013 Patented case 23 Dec, 2029
{"application_id":"52554","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"27590b06fac644e1a024","publication_number":"US9782414B2","cleaned_patent_number":"9782414","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-11-16","publication_date":"2017-10-10","legal_status":"Granted"} US9782414B2 10 Oct, 2017 Granted 16 Nov, 2035
{"application_id":"52579","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"27590b06fac644e1a024","publication_number":"US10172861B2","cleaned_patent_number":"10172861","drug_product_flag":"-, Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-11-16","publication_date":"2019-01-08","legal_status":"Granted"} US10172861B2 Molecular 08 Jan, 2019 Granted 16 Nov, 2035
{"application_id":"52580","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"27590b06fac644e1a024","publication_number":"US10285993B2","cleaned_patent_number":"10285993","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-11-16","publication_date":"2019-05-14","legal_status":"Granted"} US10285993B2 14 May, 2019 Granted 16 Nov, 2035
{"application_id":"52582","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"27590b06fac644e1a024","publication_number":"US10813936B2","cleaned_patent_number":"10813936","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-11-16","publication_date":"2020-10-27","legal_status":"Granted"} US10813936B2 27 Oct, 2020 Granted 16 Nov, 2035
{"application_id":"52581","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"27590b06fac644e1a024","publication_number":"US10799505B2","cleaned_patent_number":"10799505","drug_product_flag":"-, Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-08-15","publication_date":"2020-10-13","legal_status":"Granted"} US10799505B2 Molecular 13 Oct, 2020 Granted 15 Aug, 2036
{"application_id":"76949","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"0426a5fae49649108745","publication_number":"US10045991B2","cleaned_patent_number":"10045991","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-04-04","publication_date":"2018-08-14","legal_status":"Granted"} US10045991B2 14 Aug, 2018 Granted 04 Apr, 2037
{"application_id":"76996","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"0426a5fae49649108745","publication_number":"US10137127B2","cleaned_patent_number":"10137127","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-04-04","publication_date":"2018-11-27","legal_status":"Granted"} US10137127B2 Formulation 27 Nov, 2018 Granted 04 Apr, 2037
{"application_id":"77000","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"0426a5fae49649108745","publication_number":"US11484535B2","cleaned_patent_number":"11484535","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-04-04","publication_date":"2022-11-01","legal_status":"Granted"} US11484535B2 01 Nov, 2022 Granted 04 Apr, 2037
{"application_id":"76999","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"0426a5fae49649108745","publication_number":"US11191766B2","cleaned_patent_number":"11191766","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-04-04","publication_date":"2021-12-07","legal_status":"Granted"} US11191766B2 07 Dec, 2021 Granted 04 Apr, 2037
{"application_id":"76998","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"0426a5fae49649108745","publication_number":"US10668072B2","cleaned_patent_number":"10668072","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-04-04","publication_date":"2020-06-02","legal_status":"Granted"} US10668072B2 Formulation 02 Jun, 2020 Granted 04 Apr, 2037
{"application_id":"164408","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"","publication_number":"US11337967B2","cleaned_patent_number":"11337967","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-05-16","publication_date":"2022-05-24","legal_status":"Granted"} US11337967B2 24 May, 2022 Granted 16 May, 2037
{"application_id":"164407","ingredient":"LAROTRECTINIB SULFATE","trade_name":"VITRAKVI","family_id":"","publication_number":"US11974998B2","cleaned_patent_number":"11974998","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-05-16","publication_date":"2024-05-07","legal_status":"Granted"} US11974998B2 07 May, 2024 Granted 16 May, 2037

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

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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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