Ledipasvir; Sofosbuvir Global Patent Coverage & Expiry Overview

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It is formulated by 1 pharmaceutical company such as GILEAD SCIENCES INC. It is marketed under 1 brand name, including HARVONI. Available in 4 different strengths, such as 90MG;400MG, 33.75MG;150MG/PACKET, 45MG;200MG/PACKET and others, and administered through 2 routes including TABLET;ORAL, PELLETS;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":"30648","ingredient":"LEDIPASVIR; SOFOSBUVIR","trade_name":"HARVONI","family_id":"5fab53c5ef924a7eb815","publication_number":"US9085573B2","cleaned_patent_number":"9085573","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-09-21","publication_date":"2015-07-21","legal_status":"Granted"} US9085573B2 21 Jul, 2015 Granted 21 Sep, 2028
{"application_id":"30645","ingredient":"LEDIPASVIR; SOFOSBUVIR","trade_name":"HARVONI","family_id":"5fab53c5ef924a7eb815","publication_number":"US8735372B2","cleaned_patent_number":"8735372","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-09-21","publication_date":"2014-05-27","legal_status":"Granted"} US8735372B2 27 May, 2014 Granted 21 Sep, 2028
{"application_id":"4776","ingredient":"LEDIPASVIR; SOFOSBUVIR","trade_name":"HARVONI","family_id":"5fab53c5ef924a7eb815","publication_number":"US8334270B2","cleaned_patent_number":"8334270","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-09-21","publication_date":"2012-12-18","legal_status":"Granted"} US8334270B2 18 Dec, 2012 Granted 21 Sep, 2028
{"application_id":"30644","ingredient":"LEDIPASVIR; SOFOSBUVIR","trade_name":"HARVONI","family_id":"5fab53c5ef924a7eb815","publication_number":"US8580765B2","cleaned_patent_number":"8580765","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-09-21","publication_date":"2013-11-12","legal_status":"Granted"} US8580765B2 12 Nov, 2013 Granted 21 Sep, 2028
{"application_id":"64231","ingredient":"LEDIPASVIR; SOFOSBUVIR","trade_name":"HARVONI","family_id":"91b67092067e484583c1","publication_number":"US8633309B2","cleaned_patent_number":"8633309","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-26","publication_date":"2014-01-21","legal_status":"Granted"} US8633309B2 21 Jan, 2014 Granted 26 Sep, 2029
{"application_id":"30639","ingredient":"LEDIPASVIR; SOFOSBUVIR","trade_name":"HARVONI","family_id":"5fab53c5ef924a7eb815","publication_number":"US7964580B2","cleaned_patent_number":"7964580","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-26","publication_date":"2011-06-21","legal_status":"Granted"} US7964580B2 21 Jun, 2011 Granted 26 Sep, 2029
{"application_id":"64133","ingredient":"LEDIPASVIR; SOFOSBUVIR","trade_name":"HARVONI","family_id":"4b741f6aaf4441848f12","publication_number":"US8889159B2","cleaned_patent_number":"8889159","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-26","publication_date":"2014-11-18","legal_status":"Granted"} US8889159B2 18 Nov, 2014 Granted 26 Sep, 2029
{"application_id":"64577","ingredient":"LEDIPASVIR; SOFOSBUVIR","trade_name":"HARVONI","family_id":"c6353fd0f6344615a773","publication_number":"US9511056B2","cleaned_patent_number":"9511056","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-12","publication_date":"2016-12-06","legal_status":"Granted"} US9511056B2 06 Dec, 2016 Granted 12 Nov, 2030
{"application_id":"64572","ingredient":"LEDIPASVIR; SOFOSBUVIR","trade_name":"HARVONI","family_id":"c6353fd0f6344615a773","publication_number":"US8088368B2","cleaned_patent_number":"8088368","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-12","publication_date":"2012-01-03","legal_status":"Granted"} US8088368B2 03 Jan, 2012 Granted 12 Nov, 2030
{"application_id":"64452","ingredient":"LEDIPASVIR; SOFOSBUVIR","trade_name":"HARVONI","family_id":"c6353fd0f6344615a773","publication_number":"US8273341B2","cleaned_patent_number":"8273341","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-12","publication_date":"2012-09-25","legal_status":"Granted"} US8273341B2 25 Sep, 2012 Granted 12 Nov, 2030
{"application_id":"64575","ingredient":"LEDIPASVIR; SOFOSBUVIR","trade_name":"HARVONI","family_id":"c6353fd0f6344615a773","publication_number":"US8822430B2","cleaned_patent_number":"8822430","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-12","publication_date":"2014-09-02","legal_status":"Granted"} US8822430B2 02 Sep, 2014 Granted 12 Nov, 2030
{"application_id":"64576","ingredient":"LEDIPASVIR; SOFOSBUVIR","trade_name":"HARVONI","family_id":"c6353fd0f6344615a773","publication_number":"US8841278B2","cleaned_patent_number":"8841278","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-12","publication_date":"2014-09-23","legal_status":"Granted"} US8841278B2 23 Sep, 2014 Granted 12 Nov, 2030
{"application_id":"64390","ingredient":"LEDIPASVIR; SOFOSBUVIR","trade_name":"HARVONI","family_id":"91b67092067e484583c1","publication_number":"US9284342B2","cleaned_patent_number":"9284342","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-13","publication_date":"2016-03-15","legal_status":"Granted"} US9284342B2 15 Mar, 2016 Granted 13 Mar, 2031
{"application_id":"64384","ingredient":"LEDIPASVIR; SOFOSBUVIR","trade_name":"HARVONI","family_id":"91b67092067e484583c1","publication_number":"US8618076B2","cleaned_patent_number":"8618076","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-11","publication_date":"2013-12-31","legal_status":"Granted"} US8618076B2 31 Dec, 2013 Granted 11 Jun, 2031
{"application_id":"64214","ingredient":"LEDIPASVIR; SOFOSBUVIR","trade_name":"HARVONI","family_id":"4b741f6aaf4441848f12","publication_number":"US10456414B2","cleaned_patent_number":"10456414","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-09-14","publication_date":"2019-10-29","legal_status":"Granted"} US10456414B2 Formulation 29 Oct, 2019 Granted 14 Sep, 2032
{"application_id":"64212","ingredient":"LEDIPASVIR; SOFOSBUVIR","trade_name":"HARVONI","family_id":"4b741f6aaf4441848f12","publication_number":"US9393256B2","cleaned_patent_number":"9393256","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-14","publication_date":"2016-07-19","legal_status":"Granted"} US9393256B2 19 Jul, 2016 Granted 14 Mar, 2033
{"application_id":"94300","ingredient":"LEDIPASVIR; SOFOSBUVIR","trade_name":"HARVONI","family_id":"646a9816929a4fbeafbb","publication_number":"US10039779B2","cleaned_patent_number":"10039779","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-07-30","publication_date":"2018-08-07","legal_status":"Granted"} US10039779B2 07 Aug, 2018 Granted 30 Jul, 2034

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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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