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Last Updated: June 19, 2021

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Ledipasvir; sofosbuvir - Generic Drug Details

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What are the generic sources for ledipasvir; sofosbuvir and what is the scope of freedom to operate?

Ledipasvir; sofosbuvir is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in two NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ledipasvir; sofosbuvir has five hundred and thirty-one patent family members in forty-seven countries.

There is one drug master file entry for ledipasvir; sofosbuvir. One supplier is listed for this compound.

Recent Clinical Trials for ledipasvir; sofosbuvir

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Mansoura UniversityPhase 3
Helwan UniversityPhase 4
Cairo UniversityPhase 2/Phase 3

See all ledipasvir; sofosbuvir clinical trials

US Patents and Regulatory Information for ledipasvir; sofosbuvir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir PELLETS;ORAL 212477-001 Aug 28, 2019 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ledipasvir; sofosbuvir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2430014 16C0005 France   Get Started Free PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958/001-002 20141118
2203462 2014029 Norway   Get Started Free PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117
2430014 232 5001-2016 Slovakia   Get Started Free PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141118
2430014 2016004 Norway   Get Started Free PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958 20141203
2430014 C201630002 Spain   Get Started Free PRODUCT NAME: LEDIPASVIR; NATIONAL AUTHORISATION NUMBER: EU/1/14/958; DATE OF AUTHORISATION: 20141117; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/958; DATE OF FIRST AUTHORISATION IN EEA: 20141117
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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