Lidocaine Global Patent Coverage & Expiry Overview

Track protection status across key markets to assess launch feasibility.

It is formulated by 45 pharmaceutical companies such as EXTROVIS, RISING, WATSON LABS INC and others. It is marketed under 8 brand names, including LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE, LIDOCAINE and others. Available in 8 different strengths, such as 2%, 0.5%, 1% and others, and administered through 7 routes including INJECTABLE;INJECTION, JELLY;TOPICAL, OINTMENT;TOPICAL 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":"59233","ingredient":"LIDOCAINE HYDROCHLORIDE","trade_name":"AKTEN","family_id":"eddcba920fe94c16a162","publication_number":"US8759401B2","cleaned_patent_number":"8759401","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-24","publication_date":"2014-06-24","legal_status":"Granted"} US8759401B2 Formulation 24 Jun, 2014 Granted 24 Jul, 2026
{"application_id":"83372","ingredient":"LIDOCAINE HYDROCHLORIDE","trade_name":"ZINGO","family_id":"40f9db0f3eab41449845","publication_number":"US8540665B2","cleaned_patent_number":"8540665","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-10-22","publication_date":"2013-09-24","legal_status":"Granted"} US8540665B2 24 Sep, 2013 Granted 22 Oct, 2029
{"application_id":"55089","ingredient":"LIDOCAINE; TETRACAINE","trade_name":"PLIAGLIS","family_id":"a38b1fddf6bb48d7a9a2","publication_number":"US10603293B2","cleaned_patent_number":"10603293","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-01-14","publication_date":"2020-03-31","legal_status":"Granted"} US10603293B2 Formulation 31 Mar, 2020 Granted 14 Jan, 2031
{"application_id":"55098","ingredient":"LIDOCAINE; TETRACAINE","trade_name":"PLIAGLIS","family_id":"a38b1fddf6bb48d7a9a2","publication_number":"US10751305B2","cleaned_patent_number":"10751305","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-01-14","publication_date":"2020-08-25","legal_status":"Granted"} US10751305B2 Formulation 25 Aug, 2020 Granted 14 Jan, 2031
{"application_id":"55097","ingredient":"LIDOCAINE; TETRACAINE","trade_name":"PLIAGLIS","family_id":"a38b1fddf6bb48d7a9a2","publication_number":"US10350180B2","cleaned_patent_number":"10350180","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-01-14","publication_date":"2019-07-16","legal_status":"Granted"} US10350180B2 Formulation 16 Jul, 2019 Granted 14 Jan, 2031
{"application_id":"63994","ingredient":"LIDOCAINE","trade_name":"ZTLIDO","family_id":"ebca0253b3e24eada57c","publication_number":"US11793766B2","cleaned_patent_number":"11793766","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-05-10","publication_date":"2023-10-24","legal_status":"Granted"} US11793766B2 24 Oct, 2023 Granted 10 May, 2031
{"application_id":"63967","ingredient":"LIDOCAINE","trade_name":"ZTLIDO","family_id":"3ffc83bd7184483bb83e","publication_number":"US9283174B2","cleaned_patent_number":"9283174","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-05-10","publication_date":"2016-03-15","legal_status":"Granted"} US9283174B2 Formulation 15 Mar, 2016 Granted 10 May, 2031
{"application_id":"63968","ingredient":"LIDOCAINE","trade_name":"ZTLIDO","family_id":"3ffc83bd7184483bb83e","publication_number":"US9931403B2","cleaned_patent_number":"9931403","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-05-10","publication_date":"2018-04-03","legal_status":"Granted"} US9931403B2 Formulation 03 Apr, 2018 Granted 10 May, 2031
{"application_id":"63973","ingredient":"LIDOCAINE","trade_name":"ZTLIDO","family_id":"ebca0253b3e24eada57c","publication_number":"US10765640B2","cleaned_patent_number":"10765640","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-05-10","publication_date":"2020-09-08","legal_status":"Granted"} US10765640B2 Formulation 08 Sep, 2020 Granted 10 May, 2031
{"application_id":"63969","ingredient":"LIDOCAINE","trade_name":"ZTLIDO","family_id":"3ffc83bd7184483bb83e","publication_number":"US10765749B2","cleaned_patent_number":"10765749","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-05-10","publication_date":"2020-09-08","legal_status":"Granted"} US10765749B2 Formulation 08 Sep, 2020 Granted 10 May, 2031
{"application_id":"63970","ingredient":"LIDOCAINE","trade_name":"ZTLIDO","family_id":"3ffc83bd7184483bb83e","publication_number":"US11278623B2","cleaned_patent_number":"11278623","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-05-10","publication_date":"2022-03-22","legal_status":"Granted"} US11278623B2 Formulation 22 Mar, 2022 Granted 10 May, 2031
{"application_id":"117272","ingredient":"LIDOCAINE","trade_name":"ZTLIDO","family_id":"6d744a1cfeaf4573936f","publication_number":"US11786455B2","cleaned_patent_number":"11786455","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-05-10","publication_date":"2023-10-17","legal_status":"Granted"} US11786455B2 Formulation 17 Oct, 2023 Granted 10 May, 2031
{"application_id":"63956","ingredient":"LIDOCAINE","trade_name":"ZTLIDO","family_id":"3ffc83bd7184483bb83e","publication_number":"US9925264B2","cleaned_patent_number":"9925264","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-05-10","publication_date":"2018-03-27","legal_status":"Granted"} US9925264B2 Formulation 27 Mar, 2018 Granted 10 May, 2031
{"application_id":"83368","ingredient":"LIDOCAINE HYDROCHLORIDE","trade_name":"ZINGO","family_id":"40f9db0f3eab41449845","publication_number":"US9358338B2","cleaned_patent_number":"9358338","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-04-27","publication_date":"2016-06-07","legal_status":"Granted"} US9358338B2 07 Jun, 2016 Granted 27 Apr, 2035
{"application_id":"83352","ingredient":"LIDOCAINE HYDROCHLORIDE","trade_name":"ZINGO","family_id":"7e5dfad5562f4813ba3c","publication_number":"US9370622B2","cleaned_patent_number":"9370622","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-09-28","publication_date":"2016-06-21","legal_status":"Expired"} US9370622B2 21 Jun, 2016 Expired 28 Sep, 2035

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

NCT ID Title Status Phase Conditions Start Date Completion Date

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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