Lifitegrast Global Patent Coverage & Expiry Overview

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It is formulated by 4 pharmaceutical companies such as BAUSCH AND LOMB INC, MICRO LABS, EUGIA PHARMA and others. It is marketed under 2 brand names, including XIIDRA, LIFITEGRAST. Available in 1 different strength, such as 5%, and administered through 1 route including SOLUTION/DROPS;OPHTHALMIC.

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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":"35444","ingredient":"LIFITEGRAST","trade_name":"XIIDRA","family_id":"879bf4a7d2654c9cb2ad","publication_number":"US7314938B2","cleaned_patent_number":"7314938","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-03-10","publication_date":"2008-01-01","legal_status":"Granted"} US7314938B2 Molecular Formulation 01 Jan, 2008 Granted 10 Mar, 2025
{"application_id":"38148","ingredient":"LIFITEGRAST","trade_name":"XIIDRA","family_id":"b1145879d6eb48288659","publication_number":"US8084047B2","cleaned_patent_number":"8084047","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-05-17","publication_date":"2011-12-27","legal_status":"Patented case"} US8084047B2 Molecular Formulation 27 Dec, 2011 Patented case 17 May, 2026
{"application_id":"38149","ingredient":"LIFITEGRAST","trade_name":"XIIDRA","family_id":"b1145879d6eb48288659","publication_number":"US8592450B2","cleaned_patent_number":"8592450","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-05-17","publication_date":"2013-11-26","legal_status":"Granted"} US8592450B2 26 Nov, 2013 Granted 17 May, 2026
{"application_id":"36812","ingredient":"LIFITEGRAST","trade_name":"XIIDRA","family_id":"8f0ceed516544aa2830a","publication_number":"US9447077B2","cleaned_patent_number":"9447077","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-04-15","publication_date":"2016-09-20","legal_status":"Granted"} US9447077B2 20 Sep, 2016 Granted 15 Apr, 2029
{"application_id":"36810","ingredient":"LIFITEGRAST","trade_name":"XIIDRA","family_id":"8f0ceed516544aa2830a","publication_number":"US8367701B2","cleaned_patent_number":"8367701","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-04-15","publication_date":"2013-02-05","legal_status":"Granted"} US8367701B2 Formulation 05 Feb, 2013 Granted 15 Apr, 2029
{"application_id":"38147","ingredient":"LIFITEGRAST","trade_name":"XIIDRA","family_id":"b1145879d6eb48288659","publication_number":"US8168655B2","cleaned_patent_number":"8168655","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-05-09","publication_date":"2012-05-01","legal_status":"Granted"} US8168655B2 01 May, 2012 Granted 09 May, 2029
{"application_id":"35260","ingredient":"LIFITEGRAST","trade_name":"XIIDRA","family_id":"01990e1a42b74bb58a5d","publication_number":"US9890141B2","cleaned_patent_number":"9890141","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-10-21","publication_date":"2018-02-13","legal_status":"Granted"} US9890141B2 Molecular 13 Feb, 2018 Granted 21 Oct, 2030
{"application_id":"35259","ingredient":"LIFITEGRAST","trade_name":"XIIDRA","family_id":"6c037d2722b14f989b95","publication_number":"US9353088B2","cleaned_patent_number":"9353088","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-10-21","publication_date":"2016-05-31","legal_status":"Granted"} US9353088B2 Formulation 31 May, 2016 Granted 21 Oct, 2030
{"application_id":"35258","ingredient":"LIFITEGRAST","trade_name":"XIIDRA","family_id":"6c037d2722b14f989b95","publication_number":"US8927574B2","cleaned_patent_number":"8927574","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-12","publication_date":"2015-01-06","legal_status":"Granted"} US8927574B2 Formulation 06 Jan, 2015 Granted 12 Nov, 2030
{"application_id":"38262","ingredient":"LIFITEGRAST","trade_name":"XIIDRA","family_id":"7cae754886db41c2be5f","publication_number":"US9085553B2","cleaned_patent_number":"9085553","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-07-25","publication_date":"2015-07-21","legal_status":"Granted"} US9085553B2 Formulation 21 Jul, 2015 Granted 25 Jul, 2033
{"application_id":"40925","ingredient":"LIFITEGRAST","trade_name":"XIIDRA","family_id":"5ebc53bf56b94adc8d13","publication_number":"US11058677B2","cleaned_patent_number":"11058677","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-12-18","publication_date":"2021-07-13","legal_status":"Granted"} US11058677B2 Formulation 13 Jul, 2021 Granted 18 Dec, 2033

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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