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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Summary for SOVALDI
| International Patents: | 362 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 49 |
| Clinical Trials: | 34 |
| Drug Prices: | Drug price information for SOVALDI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SOVALDI |
| What excipients (inactive ingredients) are in SOVALDI? | SOVALDI excipients list |
| DailyMed Link: | SOVALDI at DailyMed |
Recent Clinical Trials for SOVALDI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ain Shams University | Phase 3 |
| Cairo University | Phase 3 |
| Assiut University | Early Phase 1 |
Pharmacology for SOVALDI
| Drug Class | Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor |
| Mechanism of Action | RNA Replicase Inhibitors |
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 | ||||
| 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 | PELLETS;ORAL | 212480-001 | Aug 28, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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)
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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)
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Patent: 8742
Patent: ПРОМЕЖУТОЧНЫЕ СОЕДИНЕНИЯ, ПРЕДНАЗНАЧЕННЫЕ ДЛЯ ПОЛУЧЕНИЯ НУКЛЕОЗИДНЫХ ФОСФОРОАМИДАТОВ (INTERMEDIATE COMPOUNDS USEFUL FOR PREPARING NUCLEOSIDE PHOSPHORAMIDATES)
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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
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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
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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)
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Patent: 52930
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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)
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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)
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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)
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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)
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Patent: 13337
Patent: PROCÉDÉ DE PRODUCTION DE SOFOSBUVIR (PROCESS FOR THE PRODUCTION OF SOFOSBUVIR)
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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)
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Patent: 21275
Patent: FORME CRYSTALLINE DE SOFOSBUVIR (CRYSTALLINE FORM OF SOFOSBUVIR)
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Hong Kong
Patent: 69414
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Patent: 78171
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Patent: 81775
Patent: 含磷活性物質的立體有擇合成 (STEREOSELECTIVE SYNTHESIS OF PHOSPHORUS CONTAINING ACTIVES)
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Patent: 99645
Patent: 含磷活性物質的立體選擇性合成 (STEREOSELECTIVE SYNTHESIS OF PHOSPHORUS CONTAINING ACTIVES)
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Patent: 13571
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Patent: 13572
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Patent: 17494
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Patent: 19106
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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
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Patent: 09923
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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
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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
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Patent: 09923
Estimated Expiration: ⤷ Sign Up
Patent: 90428
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Portugal
Patent: 32792
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Patent: 52930
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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
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Patent: 09923
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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
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Patent: 98358
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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 |
|---|---|---|---|
| Australia | 2011235112 | ⤷ Sign Up | |
| Montenegro | 03009 | METODE ZA LECENJE HCV-A (METHODS FOR TREATING HCV) | ⤷ Sign Up |
| Eurasian Patent Organization | 201490903 | КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ВИРУСНОГО ГЕПАТИТА C | ⤷ Sign Up |
| Philippines | 12015502237 | N- [ (2 ` R) -2 ` -DEOXY-2 ` -FLUORO-2 ` -METHYL-P-PHENYL-5 ` -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION | ⤷ Sign Up |
| Taiwan | 201139457 | Stereoselective synthesis of phosphorus containing actives | ⤷ Sign Up |
| Denmark | 2609923 | ⤷ Sign Up | |
| Chile | 2008000902 | Ester isopropilo del acido (s)-2-{[(2r,3r,4r,5r)-5-(2,4-dioxo-3,4-dihidro-2h-pirimidin-1-il)-4-fluoro-3-hidroxi-4-metil-tetrahidro-furan-2-il-metoxi]-fenoxi-fosforilamino}-propionico; proceso de preparacion, composicion farmaceutica y su uso para tratar hepatitis c, virus del west nile, virus de fiebre amarilla, virus del dengue, rinovirus, virus del polio. | ⤷ 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 | 67/2014 | Austria | ⤷ Sign Up | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117 |
| 2203462 | 2014/065 | Ireland | ⤷ Sign Up | PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116 |
| 2203462 | C20140035 00135 | Estonia | ⤷ Sign Up | PRODUCT NAME: SOFOSBUVIIR |
| 2203462 | 92600 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: SOVALDI (SOFOSBUVIR); AUTHORISATION NUMBER AND DATE: EU/1/13/894(001-002) - SOVALDI - SOFOSBUVIR 20140117 |
| 2203462 | C300704 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
| 2203462 | C 2014 043 | Romania | ⤷ Sign Up | PRODUCT NAME: SOFOSBUVIR; NATIONAL AUTHORISATION NUMBER: EU/1/13/894(001-002); DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/894(001-002); DATE OF FIRST AUTHORISATION IN EEA: 20140116 |
| 2203462 | SPC/GB14/078 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: SOFOSBUVIR; REGISTERED: UK EU/1/13/894/001 20140117; UK EU/1/13/894/002 20140117 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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