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Last Updated: July 16, 2024

SOVALDI Drug Patent Profile


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When do Sovaldi patents expire, and what generic alternatives are available?

Sovaldi is a drug marketed by Gilead Sciences Inc and is included in two NDAs. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and sixty-two patent family members in forty-eight countries.

The generic ingredient in SOVALDI is sofosbuvir. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sofosbuvir profile page.

DrugPatentWatch® Generic Entry Outlook for Sovaldi

Sovaldi was eligible for patent challenges on December 6, 2017.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for SOVALDI
Drug Prices for SOVALDI

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Recent Clinical Trials for SOVALDI

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

SponsorPhase
Cairo UniversityPhase 3
Ain Shams UniversityPhase 3
Assiut UniversityEarly Phase 1

See all SOVALDI clinical trials

Pharmacology for SOVALDI
Paragraph IV (Patent) Challenges for SOVALDI
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SOVALDI Tablets sofosbuvir 400 mg 204671 2 2017-12-06

US Patents and Regulatory Information for SOVALDI

SOVALDI is protected by nine US patents and five FDA Regulatory Exclusivities.

Patents protecting SOVALDI

Nucleoside phosphoramidate prodrugs
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Nucleoside phosphoramidate prodrugs
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Nucleoside phosphoramidate prodrugs
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Nucleoside phosphoramidates
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Nucleoside phosphoramidates
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Compositions and methods for treating hepatitis C virus
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Nucleoside phosphoramidate prodrugs
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Nucleoside phosphoramidates
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Compositions and methods for treating hepatitis C virus
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FDA Regulatory Exclusivity protecting SOVALDI

FOR THE TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 2 OR 3 INFECTION IN PEDIATRIC PATIENTS BETWEEN 3 YEARS OF AGE AND 12 YEARS OF AGE OR WEIGHING 35 KG WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
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FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
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PEDIATRIC EXCLUSIVITY
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FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
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TREATMENT OF CHRONIC HCV GENOTYPE 2 OR 3 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER OR WEIGHING AT LEAST 35 KG WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
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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 SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-002 Aug 28, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-002 Aug 28, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-002 Aug 28, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for SOVALDI

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Gilead Sciences Ireland UC Sovaldi sofosbuvir EMEA/H/C/002798
Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
Authorised no no no 2014-01-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for SOVALDI

When does loss-of-exclusivity occur for SOVALDI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 15
Patent: Nucleoside phosphoramidates
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Argentina

Patent: 0819
Patent: SINTESIS ESTEREOSELECTIVA DE ACTIVOS QUE CONTIENEN FOSFORO
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Patent: 0870
Patent: PROPANOATO CRISTALINO DE (S)-ISOPROPIL 2-(((S)-(((2R,3R,4R,5R)-5-(2,4-DIOXO-3,4-DIHIDROPIRIMIDIN-1(2H)-IL)-4-FLUORO-3-HIDROXI-4-METILTETRAHIDROFURAN-2-IL)METOXI)(FENOXI)FOSFORIL)AMINO, COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN Y USO DEL MISMO EN EL TRATAMIENTO DE INFECCIONES VIRALES, EN PARTICUL
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Patent: 1813
Patent: FOSFORAMIDATO DE NUCLEOSIDO DE PURINA
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Patent: 2937
Patent: FOSFORAMIDATOS DE NUCLEOSIDO
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Australia

Patent: 10249481
Patent: N- [ (2 ' R) -2 ' -deoxy-2 ' -fluoro-2 ' -methyl-p-phenyl-5 ' -uridylyl] -L-alanine 1-methylethyl ester and process for its production
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Patent: 11235044
Patent: Stereoselective synthesis of phosphorus containing actives
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Patent: 11235112
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Brazil

Patent: 1012781
Patent: n-[(2'r)-2'-deóxi-2'-fluor-2'-metil-p-fenil-5'-uridil]-l-alanina 1-metiletil éster e processo para sua produção
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Patent: 2012024884
Patent: síntese estereosseletiva de ativos contendo fósforo
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Patent: 2012024923
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Patent: 2013004621
Patent: fosforamidatos de nucleosídeo, seus processos de preparação, sua composição e seu uso
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Patent: 2013007556
Patent: compostos de fosforamidatos de nucleosídeo e processos para preparação destes compostos
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Canada

Patent: 63151
Patent: ESTER DE N-[(2 ' R) -2' -DESOXY-2' -FLUORO-2' -METHYL-P-PHENYL-5' -URIDYLYL]-L-ALANINE 1-METHYLETHYLE ET SON PROCEDE DE PRODUCTION (N- [(2'R) -2'-DEOXY-2'-FLUORO-2' -METHYL-P-PHENYL-5' -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION)
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Patent: 94669
Patent: PHOSPHORAMIDATES DE NUCLEOSIDES (NUCLEOSIDE PHOSPHORAMIDATES)
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Patent: 94671
Patent: SYNTHESE STEREOSELECTIVE D'AGENTS ACTIFS CONTENANT DU PHOSPHORE (STEREOSELECTIVE SYNTHESIS OF PHOSPHORUS CONTAINING ACTIVES)
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Patent: 19700
Patent: ESTER DE N-[(2 ' R) -2' -DESOXY-2' -FLUORO-2' -METHYL-P-PHENYL-5' -URIDYLYL]-L-ALANINE 1-METHYLETHYLE ET SON PROCEDE DE PRODUCTION (N- [(2'R) -2'-DEOXY-2'-FLUORO-2' -METHYL-P-PHENYL-5' -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION)
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Patent: 49694
Patent: PHOSPHORAMIDATES DE NUCLEOSIDES (NUCLEOSIDE PHOSPHORAMIDATES)
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Patent: 15187
Patent: ESTER DE N-[(2'R)-2'-DESOXY-2'-FLUORO-2'-METHYL-P-PHENYL-5'-URIDYLYL]-L-ALANINE 1-METHYLETHYLE ET SON PROCEDE DE PRODUCTION (N-[(2'R)-2'-DEOXY-2'-FLUORO-2'-METHYL-P-PHENYL-5'-URIDYLYL]-L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION)
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Patent: 88217
Patent: ESTER DE N-[(2 ' R) -2' -DESOXY-2' -FLUORO-2' -METHYL-P-PHENYL-5' -URIDYLYL]-L-ALANINE 1-METHYLETHYLE ET SON PROCEDE DE PRODUCTION (N- [(2'R) -2'-DEOXY-2'-FLUORO-2' -METHYL-P-PHENYL-5' -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION)
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Patent: 77960
Patent: ESTER DE N-[(2 ' R) -2' -DESOXY-2' -FLUORO-2' -METHYL-P-PHENYL-5' -URIDYLYL]-L-ALANINE 1-METHYLETHYLE ET SON PROCEDE DE PRODUCTION (N- [(2'R) -2'-DEOXY-2'-FLUORO-2' -METHYL-P-PHENYL-5' -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION)
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Chile

Patent: 10000520
Patent: Forma cristalina del propanoato de (s) - isopropil 2 -(((s) - (((2r,3r,4r,5r) - 5- (2,4-dioxo-3,4-dihidropirimidim-1(2h) -il)-4-fluoro-3-hidroxi-4-metitetrahidrofuran-2-il)metoxi)(fenoxi)fosforil)amino); proceso de preparacion; composicion framaceutica; y su uso para el tratamiento de una infeccion causada por el virus de la hepatitis c.
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Patent: 11000716
Patent: Formas cristalinas 1 6 de (s)-isopropil-2-(((s)-(((2r.3r.4r.5r)-5-(2,4-dioxo-3,4-dihidropirimidin-1(2h)-il)-4-fluoro-3-hidroxi-4-metil tetrahidrofuran-2-il)metoxi)(fenoxi)fosforil)amino)propanoato; composicion y combinacion farmaceutica; y su uso para tratar una infeccion por el virus de la hepatitis c.
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Patent: 11000717
Patent: Compuesto derivado de fosforamidato de nucleosido de purina, un hidrato o solvato del mismo; composicion que lo comprende; proceso de preparacion, util para el tratamiento de la infeccion por el virus de la hepatitis c (vhc).
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Patent: 11000718
Patent: Proceso para la preparacion de compuestos fosforados enantiomericos.
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Patent: 13000903
Patent: Proceso para preparar el compuesto n[(2`r)-2`-deoxi-2`-fluoro-2`-metil-p-fenil-5`-uridilil]-l-alanina-1-metiletil ester; composicion que comprende dicho compuesto; y el proceso para determinar la pureza quimica de dicho compuesto (divisional de la solicitud 520-2010).
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Patent: 13000904
Patent: Compuestos intermediarios utiles en la preparacion de fosforamidatos de nucleosidos.
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China

Patent: 2459299
Patent: N- [ (2 ' r) -2 ' -deoxy-2 ' -fluoro-2 ' -methyl-p-phenyl-5 ' -uridylyl] -l-alanine 1-methylethyl ester and process for its production
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Patent: 2858790
Patent: Nucleoside Phosphoramidates
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Patent: 2906102
Patent: Stereoselective synthesis of phosphorus containing actives
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Patent: 4017020
Patent: Nucleoside phosphoramidates
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Patent: 4292256
Patent: N- [ (2 ' R) -2 ' -deoxy-2 ' -fluoro-2 ' -methyl-p-phenyl-5 ' -uridylyl] -L-alanine 1-methylethyl ester and process for its production
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Patent: 5085592
Patent: N- [ (2 ' R) -2 ' -deoxy-2 ' -fluoro-2 ' -methyl-p-phenyl-5 ' -uridylyl] -L-alanine 1-methylethyl ester and process for its production
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Patent: 5198949
Patent: Nucleoside Phosphoramidates
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Colombia

Patent: 70789
Patent: N-[2 ́R)-2 ́-DESOXI-2 ́FLUORO-2 ́-METIL-P-FENIL-5 ́URIDILIL]-L-ALANINA 1 METILETIL ÉSTER Y PROCESO PARA SU PRODUCCIÓN
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Patent: 30166
Patent: Síntesis esteroselectiva de activos que contienen fósforo
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Patent: 30167
Patent: Fosforamidatos de nucleósido
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Costa Rica

Patent: 120532
Patent: FOSFORAMIDATOS DE NUCLEÓSIDO
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Patent: 120534
Patent: SISTESIS ESTEREOSELECTIVA DE ACTIVOS QUE CONTIENEN FÓSFORO
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Croatia

Patent: 0151075
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Patent: 0160958
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Patent: 0171267
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Cyprus

Patent: 16976
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Patent: 18045
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Patent: 19273
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Denmark

Patent: 32792
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Patent: 52930
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Patent: 09923
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Ecuador

Patent: 12012282
Patent: FOSFORAMIDATOS DE NUCLEÓSIDO
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Eurasian Patent Organization

Patent: 6341
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА НУКЛЕОЗИДФОСФОРАМИДАТА (CRYSTALLINE FORM OF NUCLEOSIDE PHOSPHORAMIDATE)
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Patent: 6731
Patent: 1-МЕТИЛЭТИЛОВЫЙ СЛОЖНЫЙ ЭФИР N-[(2'R)-2'-ДЕЗОКСИ-2'-ФТОР-2'-МЕТИЛ-Р-ФЕНИЛ-5'-УРИДИЛ]-L-АЛАНИНА И СПОСОБ ЕГО ПОЛУЧЕНИЯ (N-[(2'R)-2'-DEOXY-2'-FLUORO-2'-METHYL-P-PHENYL-5'-URIDYLYL]-L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION)
Estimated Expiration: ⤷  Sign Up

Patent: 8709
Patent: 1-МЕТИЛЭТИЛОВЫЙ СЛОЖНЫЙ ЭФИР N-[(2'R)-2'-ДЕЗОКСИ-2'-ФТОР-2'-МЕТИЛ-Р-ФЕНИЛ-5'-УРИДИЛ]-L-АЛАНИНА И СПОСОБ ЕГО ПОЛУЧЕНИЯ (N-[(2'R)-2'-DEOXY-2'-FLUORO-2'-METHYL-p-PHENYL-5'-URIDYL]-L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR PRODUCTION THEREOF)
Estimated Expiration: ⤷  Sign Up

Patent: 8742
Patent: ПРОМЕЖУТОЧНЫЕ СОЕДИНЕНИЯ, ПРЕДНАЗНАЧЕННЫЕ ДЛЯ ПОЛУЧЕНИЯ НУКЛЕОЗИДНЫХ ФОСФОРОАМИДАТОВ (INTERMEDIATE COMPOUNDS USEFUL FOR PREPARING NUCLEOSIDE PHOSPHORAMIDATES)
Estimated Expiration: ⤷  Sign Up

Patent: 1171417
Patent: 1-МЕТИЛЭТИЛОВЫЙ СЛОЖНЫЙ ЭФИР N-[(2'R)-2'-ДЕЗОКСИ-2'-ФТОР-2'-МЕТИЛ-Р-ФЕНИЛ-5'-УРИДИЛ]-L-АЛАНИНА И СПОСОБ ЕГО ПОЛУЧЕНИЯ
Estimated Expiration: ⤷  Sign Up

Patent: 1290988
Patent: СТЕРЕОСЕЛЕКТИВНЫЙ СИНТЕЗ ФОСФОРСОДЕРЖАЩИХ АКТИВНЫХ СОЕДИНЕНИЙ
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Patent: 1290993
Patent: НУКЛЕОЗИДФОСФОРАМИДАТЫ
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Patent: 1370186
Patent: 1-МЕТИЛЭТИЛОВЫЙ СЛОЖНЫЙ ЭФИР N-[(2'R)-2'-ДЕЗОКСИ-2'-ФТОР-2'-МЕТИЛ-P-ФЕНИЛ-5'-УРИДИЛ]-L-АЛАНИНА И СПОСОБ ЕГО ПОЛУЧЕНИЯ
Estimated Expiration: ⤷  Sign Up

Patent: 1592101
Patent: 1-МЕТИЛЭТИЛОВЫЙ СЛОЖНЫЙ ЭФИР N-[(2'R)-2'-ДЕЗОКСИ-2'-ФТОР-2'-МЕТИЛ-Р-ФЕНИЛ-5'-УРИДИЛ]-L-АЛАНИНА И СПОСОБ ЕГО ПОЛУЧЕНИЯ
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European Patent Office

Patent: 32792
Patent: PROCÉDÉ DE PRODUCTION D'ESTER DE N-[(2'R)-2'-DÉSOXY-2'-FLUORO-2'-MÉTHYL-P-PHÉNYL-5' -URIDYLYL]-L-ALANINE 1-MÉTHYLÉTHYLE (AND PROCESS FOR THE PREPARATION OF N-[(2'R)-2'-DEOXY-2'-FLUORO-2'-METHYL-P-PHENYL-5'-URIDYLYL]-L-ALANINE 1-METHYLETHYL ESTER)
Estimated Expiration: ⤷  Sign Up

Patent: 52930
Estimated Expiration: ⤷  Sign Up

Patent: 52931
Patent: SYNTHÈSE STÉRÉOSÉLECTIVE D'AGENTS ACTIFS CONTENANT DU PHOSPHORE (STEREOSELECTIVE SYNTHESIS OF PHOSPHORUS CONTAINING ACTIVES)
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Patent: 52933
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Patent: 09923
Patent: PROCEDE DE CRYSTALLISATION DE (S)-ISOPROPYL 2-(((S)-(PERFLUOROPHENOXY)(PHENOXY)PHOSPHORYL)AMINO)PROPANOATE (PROCESS FOR THE CRYSTALLISATION OF (S)-ISOPROPYL 2-(((S)-(PERFLUOROPHENOXY)(PHENOXY)PHOSPHORYL)AMINO)PROPANOATE)
Estimated Expiration: ⤷  Sign Up

Patent: 10264
Patent: N-[(2'r)-2'-deoxy-2'-fluoro-2'-methyl-p-phenyl-5'-uridylyl]-l-alanine 1-methylethyl ester et procédé pour sa production (N-[(2'r)-2'-deoxy-2'-fluoro-2'-methyl-p-phenyl-5'-uridylyl]-l-alanine 1-methylethyl ester and process for its production)
Estimated Expiration: ⤷  Sign Up

Patent: 52422
Patent: Synthèse stéréosélective d'agents actifs contenant du phosphore (Stereoselective synthesis of phosphorus containing actives)
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Patent: 10562
Patent: Ester de N-[(2'r)-2'-deoxy-2'-fluoro-2'-méthyl-p-phényl-5'-uridylyl]-l-alanine-1-méthyléthyle en forme cristalline (N-[(2'r)-2'-deoxy-2 '-fluoro-2'-methyl-p-phenyl-5 '-uridylyl]-l-alanine 1-methylethyl ester in crystalline form)
Estimated Expiration: ⤷  Sign Up

Patent: 13337
Patent: PROCÉDÉ DE PRODUCTION DE SOFOSBUVIR (PROCESS FOR THE PRODUCTION OF SOFOSBUVIR)
Estimated Expiration: ⤷  Sign Up

Patent: 90428
Patent: COMPRIMÉ CONTENANT CRISTALLIN (S)-ISOPROPYL 2-(((S)-(((2R,3R,4R,5R)-5-(2,4-DIOXO-3,4-DIHYDROPYRIMIDIN-1 (2H)-YL)-4-FLUORO-3-HYDROXY-4-METHYLTETRAHYDROFURAN-2-YL)METHOXY)(PHENOXY)PHOSPHORYL)AMINO)PROPANOATE (TABLET COMPRISING CRYSTALLINE (S)-ISOPROPYL 2-(((S)-(((2R,3R,4R,5R)-5-(2,4-DIOXO-3,4-DIHYDROPYRIMIDIN-1 (2H)-YL)-4-FLUORO-3-HYDROXY-4-METHYLTETRAHYDROFURAN-2-YL)METHOXY)(PHENOXY)PHOSPHORYL)AMINO)PROPANOATE)
Estimated Expiration: ⤷  Sign Up

Patent: 21275
Patent: FORME CRYSTALLINE DE SOFOSBUVIR (CRYSTALLINE FORM OF SOFOSBUVIR)
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Hong Kong

Patent: 69414
Estimated Expiration: ⤷  Sign Up

Patent: 78171
Estimated Expiration: ⤷  Sign Up

Patent: 81775
Patent: 含磷活性物質的立體有擇合成 (STEREOSELECTIVE SYNTHESIS OF PHOSPHORUS CONTAINING ACTIVES)
Estimated Expiration: ⤷  Sign Up

Patent: 99645
Patent: 含磷活性物質的立體選擇性合成 (STEREOSELECTIVE SYNTHESIS OF PHOSPHORUS CONTAINING ACTIVES)
Estimated Expiration: ⤷  Sign Up

Patent: 13571
Estimated Expiration: ⤷  Sign Up

Patent: 13572
Estimated Expiration: ⤷  Sign Up

Patent: 17494
Estimated Expiration: ⤷  Sign Up

Patent: 19106
Estimated Expiration: ⤷  Sign Up

Patent: 51578
Patent: 含結晶(S)-異丙基 2-(((S)-(((2R,3R,4R,5R)-5-(2,4-二氧代-3,4-二氫嘧啶-1(2H)-基)-4-氟-3-羥基-4-甲基四氫呋喃-2-基)甲氧基)(苯氧基)磷酰基)氨基)丙酸酯的片劑 (TABLET COMPRISING CRYSTALLINE (S)-ISOPROPYL 2-(((S)-(((2R,3R,4R,5R)-5-(2,4-DIOXO-3,4-DIHYDROPYRIMIDIN-1 (2H)-YL)-4-FLUORO-3-HYDROXY-4-METHYLTETRAHYDROFURAN-2-YL)METHOXY)(PHENOXY)PHOSPHORYL)AMINO)PROPANOATE)
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Patent: 54977
Patent: 索非布韋(SOFOSBUVIR)的結晶形式 (CRYSTALLINE FORM OF SOFOSBUVIR)
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Hungary

Patent: 26235
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Patent: 31637
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Patent: 34239
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Israel

Patent: 6492
Patent: צורות גבישיות של (s)-איזופרופיל 2-((s-(((2r,3r,4r,5r)-5-(4.2-דיאוקסו-4,3-דיהידרופירימידין-1(h2)-יל)-4-פלואורו-3-הידרוקסי-4-מתילטטרהידרופורן-2-יל)-מתוקסי)-(פנוקסי)פוספורילאמינו)פרופנואט, תכשירים רוקחיים ושימושן (Crystalline forms of (s)-isopropyl-2-((s-(((2r,3r,4r,5r)-5-(2,4-dioxo-3,4-dihydropyrimidin-1-(2h)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)-(phenoxy)phosphorylamino)propanoate, pharmaceutical compositions and uses thereof)
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Patent: 2099
Patent: צורה גבישית של נוקליאוסיד פוספורמידאט, הרכב פרמצבטיהמכיל אותה ושימוש בו (Crystalline nucleoside phosphoramidate, pharmaceutical composition comprising it and use thereof)
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Patent: 2174
Patent: סינתיזה סטריאוסלקטיבית של חומרים פעילים המכילים זרחן (Stereoselective synthesis of phosphorus containing actives)
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Patent: 7471
Patent: תולדות של [[(s1)-2-איזופרופוקסי-1-מתיל-2-אוקסו-אתיל]אמינו]-פנוקסי -פוספוריל ([[(1s)-2-isopropoxy-1-methyl-2-oxo-ethyl] amino]-phenoxy-phosphoryl derivatives)
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Patent: 9115
Patent: N-[(2'-r)-2'-דאוקסי-2'-פלואורו-2'-מתיל-p-פניל-5'-אורידיליל]-l-אלאנינ-1-מתילאתילאסטר ותהליך להכנתו (N-[(2'r)-2'-deoxy-2'-fluoro-2'-methyl-p-phenyl-5'-uridylyl]-l-alanine 1-methylethyl ester and process for its production)
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Japan

Patent: 72539
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Patent: 85659
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Patent: 09535
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Patent: 58528
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Patent: 06716
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Patent: 55605
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Patent: 12527477
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Patent: 13523767
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Patent: 13525277
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Patent: 13527145
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Patent: 15028060
Patent: N−[(2’R)−2’−デオキシ−2’−フルオロ−2’−メチル−P−フェニル−5’−ウリジリル]−L−アラニン1−メチルエチルエステルおよびその製造のためのプロセス (N-[(2'R)-2'-DEOXY-2'-FLUORO-2'-METHYL-P-PHENYL-5'-URIDYLYL]-L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION)
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Patent: 15205903
Patent: ヌクレオシドホスホルアミデート (NUCLEOSIDE PHOSPHORAMIDATE)
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Patent: 16053045
Patent: N−[(2’R)−2’−デオキシ−2’−フルオロ−2’−メチル−P−フェニル−5’−ウリジリル]−L−アラニン1−メチルエチルエステルおよびその製造のためのプロセス (N-[(2 'R)-2 '-DEOXY-2 '-FLUORO-2 '-METHYL-P-PHENYL-5'-URIDYLYL]-L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION)
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Lithuania

Patent: 32792
Estimated Expiration: ⤷  Sign Up

Patent: 09923
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 6918
Patent: N- [ (2 ' R) -2' -DEOXY-2' -FLUORO-2' -METHYL-P-PHENYL-5' -URIDYLYL] - L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION
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Mexico

Patent: 0725
Patent: FOSFORAMIDATOS DE NUCLEOSIDO. (NUCLEOSIDE PHOSPHORAMIDATES.)
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Patent: 11012417
Patent: FOSFORAMIDATOS DE NUCLEOSIDO. (N- [ (2 ' R) -2 ' -DEOXY-2 ' -FLUORO-2 ' -METHYL-P-PHENYL-5 ' -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION.)
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Patent: 12011171
Patent: FOSFORAMIDATOS DE NUCLEOSIDO. (NUCLEOSIDE PHOSPHORAMIDATES.)
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Patent: 12011324
Patent: SINTESIS ESTEREOSELECTIVA DE ACTIVOS QUE CONTIENEN FOSFORO. (STEREOSELECTIVE SYNTHESIS OF PHOSPHORUS CONTAINING ACTIVES.)
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Montenegro

Patent: 294
Patent: KRISTALNI (S)-IZOPROPIL 2-(((S)-(((2R,3R,4R,5R)-5-(2 ,4-DIOKS0-3,4-DIHIDROPIRIMIDIN-1-(2H)-IL )-4 - FLUOR0-3-HIDROKSI-4-METILTETRAHIDROFURAN-2- IL)METOKSI)(FENOKSI)FOSFORIL)AMINO)PROPANOAT (CRYSTALLINE (S)-ISOPROPYL 2-(((S)-(((2R,3R,4R,5R)-5-(2,4-DIOXO-3,4-DIHYDROPYRIMIDIN- 1-(2H)-YL)-4-FLUORO-3-HYDROXY-4-METHYLTETRAHYDROFURAN-2-YL)METHOXY) (PHENOXY)PHOSPHORYL)AMINO)PROPANOATE)
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Patent: 846
Patent: POSTUPAK ZA KRISTALIZACIJU (S) - IZOPROPIL 2- (((S) - (PERFLUOROFENOKSI)( FENOKSI)FOSFORIL)AMINO) PROPANOATA (PROCESS FOR THE CRYSTALLISATION OF (S)-ISOPROPYL 2- (((S)-(PERFLUOROPHENOXY)(PHENOXY)PHOSPHORYL) AMlNO)PROPANOATE)
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New Zealand

Patent: 6635
Patent: N-[(2’r)-2’-deoxy-2’-fluoro-2’-methyl-p-phenyl-5’-uridylyl]-l-alanine 1-methylethyl ester and process for its production
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Patent: 3232
Patent: Nucleoside phosphoramidates
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Patent: 3602
Patent: N-[(2’r)-2’-deoxy-2’-fluoro-2’-methyl-p-phenyl-5’-uridylyl]-l-alanine 1-methylethyl ester and process for its production
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Patent: 9926
Patent: N-[(2’r)-2’-deoxy-2’-fluoro-2’-methyl-p-phenyl-5’-uridylyl]-l-alanine 1-methylethyl ester and process for its production
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Peru

Patent: 130151
Patent: SINTESIS ESTEREOSELECTIVA DE ACTIVOS QUE CONTIENEN FOSFORO
Estimated Expiration: ⤷  Sign Up

Patent: 130183
Patent: FOSFORAMIDATOS DE NUCLEOSIDO
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Philippines

Patent: 014502684
Patent: N- [ (2`R) -2`-DEOXY-2`-FLUORO-2`-METHYL-P-PHENYL-5`-URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION
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Patent: 015502237
Patent: N- [ (2 ` R) -2 ` -DEOXY-2 ` -FLUORO-2 ` -METHYL-P-PHENYL-5 ` -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION
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Poland

Patent: 32792
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Patent: 52930
Estimated Expiration: ⤷  Sign Up

Patent: 09923
Estimated Expiration: ⤷  Sign Up

Patent: 90428
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 32792
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Patent: 52930
Estimated Expiration: ⤷  Sign Up

Patent: 09923
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Patent: 52422
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Patent: 13337
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Patent: 90428
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San Marino

Patent: 01500285
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Patent: 01600316
Patent: E PROCEDIMENTO PER LA PREPARAZIONE DELL'ESTERE 1-METILETILICO DI N-[(2'R)- 2'-DEOSSI-2'-FLUORO-2'-METIL-P-FENIL-5'- URIDILlL]-L-ALANINA
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Serbia

Patent: 368
Patent: KRISTALNI (S)-IZOPROPIL 2-(((S)-(((2R,3R,4R,5R)-5-(2,4-DIOKSO-3,4-DIHIDROPIRIMIDIN-1-(2H)-IL)-4-FLUORO-3-HIDROKSI-4-METILTETRAHIDROFURAN-2-IL)METOKSI)(FENOKSI)FOSFORIL)AMINO)PROPANOAT (CRYSTALLINE (S)-ISOPROPYL 2-(((S)-(((2R,3R,4R,5R)-5-(2,4-DIOXO-3,4-DIHYDROPYRIMIDIN-1-(2H)-YL)-4-FLUORO-3-HYDROXY-4-METHYLTETRAHYDROFURAN-2-YL)METHOXY)(PHENOXY)PHOSPHORYL)AMINO)PROPANOATE)
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Patent: 229
Patent: POSTUPAK ZA KRISTALIZACIJU (S)-IZOPROPIL 2-(((S)-(PERFLUOROFENOKSI)(FENOKSI)FOSFORIL)AMINO)PROPANOATA (PROCESS FOR THE CRYSTALLISATION OF (S)-ISOPROPYL 2-(((S)-(PERFLUOROPHENOXY)(PHENOXY)PHOSPHORYL)AMINO)PROPANOATE)
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Singapore

Patent: 6197
Patent: N- [ (2 ' R) -2 ' -DEOXY-2 ' -FLUORO-2 ' -METHYL-P-PHENYL-5 ' -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION
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Patent: 4323
Patent: STEREOSELECTIVE SYNTHESIS OF PHOSPHORUS CONTAINING ACTIVES
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Patent: 4324
Patent: NUCLEOSIDE PHOSPHORAMIDATES
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Patent: 201500835W
Patent: N- [ (2 ' R) -2 ' -DEOXY-2 ' -FLUORO-2 ' -METHYL-P-PHENYL-5 ' -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION
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Patent: 201702025S
Patent: NUCLEOSIDE PHOSPHORAMIDATES
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Patent: 201702294Q
Patent: N- [ (2 ' R) -2 ' -DEOXY-2 ' -FLUORO-2 ' -METHYL-P-PHENYL-5 ' -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION
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Patent: 201708263S
Patent: N- [ (2 ' R) -2 ' -DEOXY-2 ' -FLUORO-2 ' -METHYL-P-PHENYL-5 ' -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION
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Slovenia

Patent: 32792
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Patent: 52930
Estimated Expiration: ⤷  Sign Up

Patent: 09923
Estimated Expiration: ⤷  Sign Up

Patent: 90428
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South Africa

Patent: 1108749
Patent: N-[(2'R)-2'-DEOXY-2'-FLUORO-2'-METHYL-P-PHENYL-5'-URIDYLYL]-ALANINE 1 -METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION
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Patent: 1207799
Patent: NUCLEOSIDE PHOSPHORAMIDATES
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Patent: 1207800
Patent: STEREOSELECTIVE SYNTHESIS OF PHOSPHORUS CONTAINING ACTIVES
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Patent: 1400249
Patent: NUCLEOSIDE PHOSPHORAMIDATES
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South Korea

Patent: 1599183
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Patent: 1603817
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Patent: 1715981
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Patent: 1759369
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Patent: 120034662
Patent: N-[(2'R)-2'-DEOXY-2'-FLUORO-2'-METHYL-P-PHENYL-5'-URIDYLYL]-L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION
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Patent: 120138242
Patent: NUCLEOSIDE PHOSPHORAMIDATES
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Patent: 130064064
Patent: STEREOSELECTIVE SYNTHESIS OF PHOSPHORUS CONTAINING ACTIVES
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Patent: 140147144
Patent: N-[(2'R)-2'-DEOXY-2'-FLUORO-2'-METHYL-P-PHENYL-5'-URIDYLYL]-L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION
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Patent: 150043553
Patent: N-〔(2''R)-2''-데옥시-2''-플루오로-2''-메틸-P-페닐-5''-우리딜일〕-L-알라닌 1-메틸에틸 에스테르 및 이의 생산 방법 (N-[(2'R)-2'-DEOXY-2'-FLUORO-2'-METHYL-P-PHENYL-5'-URIDYLYL]-L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION)
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Spain

Patent: 16466
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Patent: 51944
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Patent: 86821
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Patent: 38350
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Patent: 44990
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Patent: 48803
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Patent: 00773
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Patent: 27501
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Taiwan

Patent: 98117
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Patent: 76352
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Patent: 83692
Estimated Expiration: ⤷  Sign Up

Patent: 98358
Estimated Expiration: ⤷  Sign Up

Patent: 1107341
Patent: Nucleoside phosphoramidates
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Patent: 1136593
Patent: Nucleoside phosphoramidates
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Patent: 1136945
Patent: Purine nucleoside phosphoramidate
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Patent: 1139457
Patent: Stereoselective synthesis of phosphorus containing actives
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Patent: 1518313
Patent: Nucleoside phosphoramidates
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Patent: 1704249
Patent: Nucleoside phosphoramidates
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Ukraine

Patent: 2959
Patent: НУКЛЕОЗИДФОСФОРАМІДАТИ
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Uruguay

Patent: 310
Patent: SINTESIS ESTEREOSELECTIVA DE ACTIVOS QUE CONTIENEN FOSFORO
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Patent: 311
Patent: FOSFORAMIDATOS DE NUCLEOSIDOS
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Patent: 312
Patent: FOSFORAMIDATO DE NUCLEOSIDO DE PURINA
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Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SOVALDI around the world.

Country Patent Number Title Estimated Expiration
Ukraine 116087 КОМПОЗИЦІЯ ДЛЯ ЛІКУВАННЯ ВІРУСУ ГЕПАТИТУ C (METHODS FOR TREATING HCV) ⤷  Sign Up
Japan 2018197245 ヌクレオシドホスホロアミデートプロドラッグ (NUCLEOSIDE PHOSPHORAMIDATE PRODRUGS) ⤷  Sign Up
European Patent Office 2910562 Ester de N-[(2'r)-2'-deoxy-2'-fluoro-2'-méthyl-p-phényl-5'-uridylyl]-l-alanine-1-méthyléthyle en forme cristalline (N-[(2'r)-2'-deoxy-2 '-fluoro-2'-methyl-p-phenyl-5 '-uridylyl]-l-alanine 1-methylethyl ester in crystalline form) ⤷  Sign Up
Singapore 184323 STEREOSELECTIVE SYNTHESIS OF PHOSPHORUS CONTAINING ACTIVES ⤷  Sign Up
Poland 2432792 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SOVALDI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203462 C300704 Netherlands ⤷  Sign Up PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462 300704 Netherlands ⤷  Sign Up PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462 132014902310732 Italy ⤷  Sign Up PRODUCT NAME: SOFOSBUVIR(SOVALDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/894, 20140117
2203462 14C0082 France ⤷  Sign Up PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462 1490066-6 Sweden ⤷  Sign Up PRODUCT NAME: SOFOSBUVIR
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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