Difelikefalin Acetate Global Patent Coverage & Expiry Overview

Track protection status across key markets to assess launch feasibility.

It is formulated by 1 pharmaceutical company such as VIFOR INTL. It is marketed under 1 brand name, including KORSUVA. Available in 1 different strength, such as EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML), and administered through 1 route including SOLUTION;INTRAVENOUS.

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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":"73925","ingredient":"DIFELIKEFALIN ACETATE","trade_name":"KORSUVA","family_id":"81505292c66d43209b52","publication_number":"US10017536B2","cleaned_patent_number":"10017536","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-12","publication_date":"2018-07-10","legal_status":"Granted"} US10017536B2 Molecular 10 Jul, 2018 Granted 12 Nov, 2027
{"application_id":"73926","ingredient":"DIFELIKEFALIN ACETATE","trade_name":"KORSUVA","family_id":"81505292c66d43209b52","publication_number":"US10138270B2","cleaned_patent_number":"10138270","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-12","publication_date":"2018-11-27","legal_status":"Granted"} US10138270B2 27 Nov, 2018 Granted 12 Nov, 2027
{"application_id":"73878","ingredient":"DIFELIKEFALIN ACETATE","trade_name":"KORSUVA","family_id":"81505292c66d43209b52","publication_number":"US10793596B2","cleaned_patent_number":"10793596","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-12","publication_date":"2020-10-06","legal_status":"Granted"} US10793596B2 Molecular Formulation 06 Oct, 2020 Granted 12 Nov, 2027
{"application_id":"73912","ingredient":"DIFELIKEFALIN ACETATE","trade_name":"KORSUVA","family_id":"81505292c66d43209b52","publication_number":"US7402564B1","cleaned_patent_number":"7402564","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-12","publication_date":"2008-07-22","legal_status":"Granted"} US7402564B2 Molecular Formulation 22 Jul, 2008 Granted 12 Nov, 2027
{"application_id":"73913","ingredient":"DIFELIKEFALIN ACETATE","trade_name":"KORSUVA","family_id":"81505292c66d43209b52","publication_number":"US7713937B2","cleaned_patent_number":"7713937","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-12","publication_date":"2010-05-11","legal_status":"Granted"} US7713937B2 Molecular Formulation 11 May, 2010 Granted 12 Nov, 2027
{"application_id":"73914","ingredient":"DIFELIKEFALIN ACETATE","trade_name":"KORSUVA","family_id":"81505292c66d43209b52","publication_number":"US7727963B2","cleaned_patent_number":"7727963","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-12","publication_date":"2010-06-01","legal_status":"Granted"} US7727963B2 Molecular Formulation 01 Jun, 2010 Granted 12 Nov, 2027
{"application_id":"73916","ingredient":"DIFELIKEFALIN ACETATE","trade_name":"KORSUVA","family_id":"81505292c66d43209b52","publication_number":"US8217007B1","cleaned_patent_number":"8217007","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-12","publication_date":"2012-07-10","legal_status":"Granted"} US8217007B2 10 Jul, 2012 Granted 12 Nov, 2027
{"application_id":"118903","ingredient":"DIFELIKEFALIN ACETATE","trade_name":"KORSUVA","family_id":"59be2f390e1443e6b8db","publication_number":"US8236766B2","cleaned_patent_number":"8236766","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-12","publication_date":"2012-08-07","legal_status":"Granted"} US8236766B2 07 Aug, 2012 Granted 12 Nov, 2027
{"application_id":"73918","ingredient":"DIFELIKEFALIN ACETATE","trade_name":"KORSUVA","family_id":"81505292c66d43209b52","publication_number":"US8486894B2","cleaned_patent_number":"8486894","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-12","publication_date":"2013-07-16","legal_status":"Granted"} US8486894B2 16 Jul, 2013 Granted 12 Nov, 2027
{"application_id":"118905","ingredient":"DIFELIKEFALIN ACETATE","trade_name":"KORSUVA","family_id":"59be2f390e1443e6b8db","publication_number":"US8536131B2","cleaned_patent_number":"8536131","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-12","publication_date":"2013-09-17","legal_status":"Granted"} US8536131B2 Molecular Formulation 17 Sep, 2013 Granted 12 Nov, 2027
{"application_id":"118909","ingredient":"DIFELIKEFALIN ACETATE","trade_name":"KORSUVA","family_id":"59be2f390e1443e6b8db","publication_number":"US9334305B2","cleaned_patent_number":"9334305","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-12","publication_date":"2016-05-10","legal_status":"Granted"} US9334305B2 10 May, 2016 Granted 12 Nov, 2027
{"application_id":"118910","ingredient":"DIFELIKEFALIN ACETATE","trade_name":"KORSUVA","family_id":"59be2f390e1443e6b8db","publication_number":"US9359399B2","cleaned_patent_number":"9359399","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-12","publication_date":"2016-06-07","legal_status":"Granted"} US9359399B2 07 Jun, 2016 Granted 12 Nov, 2027

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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