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 fifty-three patent family members in forty-seven 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 five 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
Summary for SOVALDI
| International Patents: | 353 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 49 |
| Clinical Trials: | 34 |
| Patent Applications: | 1,178 |
| Formulation / Manufacturing: | see details |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes 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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Nucleoside phosphoramidate prodrugs
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Nucleoside phosphoramidate prodrugs
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Nucleoside phosphoramidates
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Nucleoside phosphoramidates
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compositions and methods for treating hepatitis C virus
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Nucleoside phosphoramidate prodrugs
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Nucleoside phosphoramidates
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compositions and methods for treating hepatitis C virus
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Exclusivity Expiration: ⤷ Try a Trial
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)
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
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)
Exclusivity Expiration: ⤷ Try a Trial
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
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Gilead Sciences Inc | SOVALDI | sofosbuvir | TABLET;ORAL | 204671-002 | Aug 28, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Gilead Sciences Inc | SOVALDI | sofosbuvir | TABLET;ORAL | 204671-001 | Dec 6, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Gilead Sciences Inc | SOVALDI | sofosbuvir | TABLET;ORAL | 204671-002 | Aug 28, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Gilead Sciences Inc | SOVALDI | sofosbuvir | TABLET;ORAL | 204671-002 | Aug 28, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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
Estimated Expiration: ⤷ Try a Trial
Argentina
Patent: 0819
Estimated Expiration: ⤷ Try a Trial
Patent: 0870
Estimated Expiration: ⤷ Try a Trial
Patent: 1813
Estimated Expiration: ⤷ Try a Trial
Patent: 2937
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 10249481
Estimated Expiration: ⤷ Try a Trial
Patent: 11235044
Estimated Expiration: ⤷ Try a Trial
Patent: 11235112
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 1012781
Estimated Expiration: ⤷ Try a Trial
Patent: 2012024884
Estimated Expiration: ⤷ Try a Trial
Patent: 2012024923
Estimated Expiration: ⤷ Try a Trial
Patent: 2013004621
Estimated Expiration: ⤷ Try a Trial
Patent: 2013007556
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 63151
Estimated Expiration: ⤷ Try a Trial
Patent: 94669
Estimated Expiration: ⤷ Try a Trial
Patent: 94671
Estimated Expiration: ⤷ Try a Trial
Patent: 19700
Estimated Expiration: ⤷ Try a Trial
Patent: 49694
Estimated Expiration: ⤷ Try a Trial
Patent: 15187
Estimated Expiration: ⤷ Try a Trial
Patent: 88217
Estimated Expiration: ⤷ Try a Trial
Patent: 77960
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 10000520
Estimated Expiration: ⤷ Try a Trial
Patent: 11000716
Estimated Expiration: ⤷ Try a Trial
Patent: 11000717
Estimated Expiration: ⤷ Try a Trial
Patent: 11000718
Estimated Expiration: ⤷ Try a Trial
Patent: 13000903
Estimated Expiration: ⤷ Try a Trial
Patent: 13000904
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2459299
Estimated Expiration: ⤷ Try a Trial
Patent: 2858790
Estimated Expiration: ⤷ Try a Trial
Patent: 2906102
Estimated Expiration: ⤷ Try a Trial
Patent: 4017020
Estimated Expiration: ⤷ Try a Trial
Patent: 4292256
Estimated Expiration: ⤷ Try a Trial
Patent: 5085592
Estimated Expiration: ⤷ Try a Trial
Patent: 5198949
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 70789
Estimated Expiration: ⤷ Try a Trial
Patent: 30166
Estimated Expiration: ⤷ Try a Trial
Patent: 30167
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 120532
Estimated Expiration: ⤷ Try a Trial
Patent: 120534
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0151075
Estimated Expiration: ⤷ Try a Trial
Patent: 0160958
Estimated Expiration: ⤷ Try a Trial
Patent: 0171267
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 16976
Estimated Expiration: ⤷ Try a Trial
Patent: 18045
Estimated Expiration: ⤷ Try a Trial
Patent: 19273
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 32792
Estimated Expiration: ⤷ Try a Trial
Patent: 52930
Estimated Expiration: ⤷ Try a Trial
Patent: 09923
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 12012282
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 6341
Estimated Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent: 8742
Estimated Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent: 1290988
Estimated Expiration: ⤷ Try a Trial
Patent: 1290993
Estimated Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 32792
Estimated Expiration: ⤷ Try a Trial
Patent: 52930
Estimated Expiration: ⤷ Try a Trial
Patent: 52931
Estimated Expiration: ⤷ Try a Trial
Patent: 52933
Estimated Expiration: ⤷ Try a Trial
Patent: 09923
Estimated Expiration: ⤷ Try a Trial
Patent: 10264
Estimated Expiration: ⤷ Try a Trial
Patent: 52422
Estimated Expiration: ⤷ Try a Trial
Patent: 10562
Estimated Expiration: ⤷ Try a Trial
Patent: 13337
Estimated Expiration: ⤷ Try a Trial
Patent: 90428
Estimated Expiration: ⤷ Try a Trial
Patent: 21275
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 69414
Estimated Expiration: ⤷ Try a Trial
Patent: 78171
Estimated Expiration: ⤷ Try a Trial
Patent: 81775
Estimated Expiration: ⤷ Try a Trial
Patent: 99645
Estimated Expiration: ⤷ Try a Trial
Patent: 13571
Estimated Expiration: ⤷ Try a Trial
Patent: 13572
Estimated Expiration: ⤷ Try a Trial
Patent: 17494
Estimated Expiration: ⤷ Try a Trial
Patent: 19106
Estimated Expiration: ⤷ Try a Trial
Patent: 51578
Estimated Expiration: ⤷ Try a Trial
Patent: 54977
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 26235
Estimated Expiration: ⤷ Try a Trial
Patent: 31637
Estimated Expiration: ⤷ Try a Trial
Patent: 34239
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 6492
Estimated Expiration: ⤷ Try a Trial
Patent: 2099
Estimated Expiration: ⤷ Try a Trial
Patent: 2174
Estimated Expiration: ⤷ Try a Trial
Patent: 7471
Estimated Expiration: ⤷ Try a Trial
Patent: 9115
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 72539
Estimated Expiration: ⤷ Try a Trial
Patent: 85659
Estimated Expiration: ⤷ Try a Trial
Patent: 09535
Estimated Expiration: ⤷ Try a Trial
Patent: 58528
Estimated Expiration: ⤷ Try a Trial
Patent: 06716
Estimated Expiration: ⤷ Try a Trial
Patent: 55605
Estimated Expiration: ⤷ Try a Trial
Patent: 12527477
Estimated Expiration: ⤷ Try a Trial
Patent: 13523767
Estimated Expiration: ⤷ Try a Trial
Patent: 13525277
Estimated Expiration: ⤷ Try a Trial
Patent: 13527145
Estimated Expiration: ⤷ Try a Trial
Patent: 15028060
Estimated Expiration: ⤷ Try a Trial
Patent: 15205903
Estimated Expiration: ⤷ Try a Trial
Patent: 16053045
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 32792
Estimated Expiration: ⤷ Try a Trial
Patent: 09923
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 6918
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 0725
Estimated Expiration: ⤷ Try a Trial
Patent: 11012417
Estimated Expiration: ⤷ Try a Trial
Patent: 12011171
Estimated Expiration: ⤷ Try a Trial
Patent: 12011324
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 294
Estimated Expiration: ⤷ Try a Trial
Patent: 846
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 6635
Estimated Expiration: ⤷ Try a Trial
Patent: 3232
Estimated Expiration: ⤷ Try a Trial
Patent: 3602
Estimated Expiration: ⤷ Try a Trial
Patent: 9926
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 130151
Estimated Expiration: ⤷ Try a Trial
Patent: 130183
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 014502684
Estimated Expiration: ⤷ Try a Trial
Patent: 015502237
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 32792
Estimated Expiration: ⤷ Try a Trial
Patent: 52930
Estimated Expiration: ⤷ Try a Trial
Patent: 09923
Estimated Expiration: ⤷ Try a Trial
Patent: 90428
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 32792
Estimated Expiration: ⤷ Try a Trial
Patent: 52930
Estimated Expiration: ⤷ Try a Trial
Patent: 09923
Estimated Expiration: ⤷ Try a Trial
Patent: 52422
Estimated Expiration: ⤷ Try a Trial
Patent: 13337
Estimated Expiration: ⤷ Try a Trial
Patent: 90428
Estimated Expiration: ⤷ Try a Trial
San Marino
Patent: 01500285
Estimated Expiration: ⤷ Try a Trial
Patent: 01600316
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 368
Estimated Expiration: ⤷ Try a Trial
Patent: 229
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 6197
Estimated Expiration: ⤷ Try a Trial
Patent: 4323
Estimated Expiration: ⤷ Try a Trial
Patent: 4324
Estimated Expiration: ⤷ Try a Trial
Patent: 201500835W
Estimated Expiration: ⤷ Try a Trial
Patent: 201702025S
Estimated Expiration: ⤷ Try a Trial
Patent: 201702294Q
Estimated Expiration: ⤷ Try a Trial
Patent: 201708263S
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 32792
Estimated Expiration: ⤷ Try a Trial
Patent: 52930
Estimated Expiration: ⤷ Try a Trial
Patent: 09923
Estimated Expiration: ⤷ Try a Trial
Patent: 90428
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1108749
Estimated Expiration: ⤷ Try a Trial
Patent: 1207799
Estimated Expiration: ⤷ Try a Trial
Patent: 1207800
Estimated Expiration: ⤷ Try a Trial
Patent: 1400249
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1599183
Estimated Expiration: ⤷ Try a Trial
Patent: 1603817
Estimated Expiration: ⤷ Try a Trial
Patent: 1715981
Estimated Expiration: ⤷ Try a Trial
Patent: 1759369
Estimated Expiration: ⤷ Try a Trial
Patent: 120034662
Estimated Expiration: ⤷ Try a Trial
Patent: 120138242
Estimated Expiration: ⤷ Try a Trial
Patent: 130064064
Estimated Expiration: ⤷ Try a Trial
Patent: 140147144
Estimated Expiration: ⤷ Try a Trial
Patent: 150043553
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 16466
Estimated Expiration: ⤷ Try a Trial
Patent: 51944
Estimated Expiration: ⤷ Try a Trial
Patent: 86821
Estimated Expiration: ⤷ Try a Trial
Patent: 38350
Estimated Expiration: ⤷ Try a Trial
Patent: 44990
Estimated Expiration: ⤷ Try a Trial
Patent: 48803
Estimated Expiration: ⤷ Try a Trial
Patent: 00773
Estimated Expiration: ⤷ Try a Trial
Patent: 27501
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 98117
Estimated Expiration: ⤷ Try a Trial
Patent: 76352
Estimated Expiration: ⤷ Try a Trial
Patent: 83692
Estimated Expiration: ⤷ Try a Trial
Patent: 98358
Estimated Expiration: ⤷ Try a Trial
Patent: 1107341
Estimated Expiration: ⤷ Try a Trial
Patent: 1136593
Estimated Expiration: ⤷ Try a Trial
Patent: 1136945
Estimated Expiration: ⤷ Try a Trial
Patent: 1139457
Estimated Expiration: ⤷ Try a Trial
Patent: 1518313
Estimated Expiration: ⤷ Try a Trial
Patent: 1704249
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 2959
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 310
Estimated Expiration: ⤷ Try a Trial
Patent: 311
Estimated Expiration: ⤷ Try a Trial
Patent: 312
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| European Patent Office | 2913337 | PROCÉDÉ DE PRODUCTION DE SOFOSBUVIR (PROCESS FOR THE PRODUCTION OF SOFOSBUVIR) | ⤷ Try a Trial |
| Philippines | 12014501133 | COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS | ⤷ Try a Trial |
| Mexico | 2011012417 | 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.) | ⤷ Try a Trial |
| Spain | 2745462 | ⤷ Try a Trial | |
| Cyprus | 1119896 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SOVALDI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2203462 | 300704 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
| 2203462 | C02203462/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014 |
| 2430014 | 2016C/006 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LEDIPASVIR/SOFOSBUVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/958 20141118 |
| 2635588 | C02635588/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: VELPATASVIR + SOFOSBUVIR + VOXILAPREVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66510 08.12.2017 |
| 2203462 | CA 2014 00061 | Denmark | ⤷ Try a Trial | PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116 |
| >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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