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Last Updated: June 28, 2022

LEDIPASVIR; SOFOSBUVIR - Generic Drug Details


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What are the generic sources for ledipasvir; sofosbuvir and what is the scope of patent protection?

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 forty-three patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for LEDIPASVIR; SOFOSBUVIR
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir PELLETS;ORAL 212477-002 Aug 28, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir PELLETS;ORAL 212477-002 Aug 28, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for LEDIPASVIR; SOFOSBUVIR

Country Patent Number Title Estimated Expiration
Chile 2014001397 Composicion farmaceutica que comprende a) gs-7977 y b) al menos un excipiente farmaceuticamente estable; forma de dosificacion unitaria; proceso de preparacion de la composicion; uso de la composicion para tratar una infeccion causada por el virus de la hepatitis c. See Plans and Pricing
Spain 2548156 See Plans and Pricing
Spain 2758726 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LEDIPASVIR; SOFOSBUVIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2430014 2016C/006 Belgium See Plans and Pricing PRODUCT NAME: LEDIPASVIR/SOFOSBUVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/958 20141118
2430014 2016/002 Ireland See Plans and Pricing PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141117
2430014 CR 2016 00006 Denmark See Plans and Pricing PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958/001-002 20141118
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Dow
Colorcon
Moodys
Mallinckrodt
Baxter

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