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Last Updated: June 29, 2022

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 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 Y See Plans and Pricing
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir PELLETS;ORAL 212477-001 Aug 28, 2019 RX Yes No 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
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-002 Aug 28, 2019 RX Yes No See Plans and Pricing See Plans and Pricing 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
European Patent Office 2552933 HYDRATE DE L'ISOPROPYL ESTER DE L'ACIDE (S)-2-{(S)-[(1R,4R,5R)-5-(2-AMINO-6-METHOXY- PURIN-9-YL)-4-(R)-FLUORO-3-HYDROXY-4-METHYL-TETRAHYDRO-FURAN-2-YLMETHOXY]- PHENOXY-PHOSPHORYLAMINO}-PROPIONIQUE DANS L'UTILISATION POUR LE TRAITEMENT DU VHC ((S)-2-{(S)-[(1R,4R,5R)-5-(2-AMINO-6-METHOXY- PURIN-9-YL)-4-(R)-FLUORO-3-HYDROXY-4-METHYL-TETRAHYDRO-FURAN-2-YLMETHOXY]- PHENOXY-PHOSPHORYLAMINO}-PROPIONIC ACID ISOPROPYL ESTER HYDRATE FOR USE IN TREATING HCV) See Plans and Pricing
Brazil 112012024923 "fosforamidatos de nucleosídeo, composição, comprimido, e seus usos" See Plans and Pricing
Israel 216254 תרכובות , הרכבים פרמצבטיים ושימושים שלהם (Compounds, pharmaceutical compositions comprising the same and uses thereof) See Plans and Pricing
Taiwan 201136593 Nucleoside phosphoramidates See Plans and Pricing
Brazil 112014012739 composições e métodos para o tratamento do vírus da hepatite c 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 122016000009 Germany See Plans and Pricing PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141117
2430014 C201630002 Spain See Plans and Pricing 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
2430014 4/2016 Austria See Plans and Pricing PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 (MITTEILUNG) 20141118
2203462 122014000108 Germany See Plans and Pricing PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2430014 C20160002 Estonia See Plans and Pricing PRODUCT NAME: LEDIPASVIIR; NATIONAL AUTHORISATION NUMBER: EMA/498767/2019; DATE OF AUTHORISATION: 20200430
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Medtronic
McKesson
Colorcon
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.