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Last Updated: May 24, 2022

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-one 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® Litigation and Generic Entry Outlook for Sovaldi

A generic version of SOVALDI was approved as sofosbuvir by TEVA PHARMS USA INC on January 27th, 2022.

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Drug patent expirations by year for SOVALDI
Drug Prices for SOVALDI

See drug prices for SOVALDI

Recent Clinical Trials for SOVALDI

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

SponsorPhase
Assiut UniversityEarly Phase 1
Hospital do CoracaoPhase 2/Phase 3
Ginkgopharma CO., LTDPhase 2

See all SOVALDI clinical trials

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidate prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidate prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for treating hepatitis C virus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidate prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nucleoside phosphoramidates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for treating hepatitis C virus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing

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: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

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: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-002 Aug 28, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-002 Aug 28, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-002 Aug 28, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-002 Aug 28, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for 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: See Plans and Pricing

Argentina

Patent: 0819
Estimated Expiration: See Plans and Pricing

Patent: 0870
Estimated Expiration: See Plans and Pricing

Patent: 1813
Estimated Expiration: See Plans and Pricing

Patent: 2937
Estimated Expiration: See Plans and Pricing

Australia

Patent: 10249481
Estimated Expiration: See Plans and Pricing

Patent: 11235044
Estimated Expiration: See Plans and Pricing

Patent: 11235112
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 1012781
Estimated Expiration: See Plans and Pricing

Patent: 2012024884
Estimated Expiration: See Plans and Pricing

Patent: 2012024923
Estimated Expiration: See Plans and Pricing

Patent: 2013004621
Estimated Expiration: See Plans and Pricing

Patent: 2013007556
Estimated Expiration: See Plans and Pricing

Canada

Patent: 63151
Estimated Expiration: See Plans and Pricing

Patent: 94669
Estimated Expiration: See Plans and Pricing

Patent: 94671
Estimated Expiration: See Plans and Pricing

Patent: 19700
Estimated Expiration: See Plans and Pricing

Patent: 49694
Estimated Expiration: See Plans and Pricing

Patent: 15187
Estimated Expiration: See Plans and Pricing

Patent: 88217
Estimated Expiration: See Plans and Pricing

Patent: 77960
Estimated Expiration: See Plans and Pricing

Chile

Patent: 10000520
Estimated Expiration: See Plans and Pricing

Patent: 11000716
Estimated Expiration: See Plans and Pricing

Patent: 11000717
Estimated Expiration: See Plans and Pricing

Patent: 11000718
Estimated Expiration: See Plans and Pricing

Patent: 13000903
Estimated Expiration: See Plans and Pricing

Patent: 13000904
Estimated Expiration: See Plans and Pricing

China

Patent: 2459299
Estimated Expiration: See Plans and Pricing

Patent: 2858790
Estimated Expiration: See Plans and Pricing

Patent: 2906102
Estimated Expiration: See Plans and Pricing

Patent: 4017020
Estimated Expiration: See Plans and Pricing

Patent: 4292256
Estimated Expiration: See Plans and Pricing

Patent: 5085592
Estimated Expiration: See Plans and Pricing

Patent: 5198949
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 70789
Estimated Expiration: See Plans and Pricing

Patent: 30166
Estimated Expiration: See Plans and Pricing

Patent: 30167
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 120532
Estimated Expiration: See Plans and Pricing

Patent: 120534
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0151075
Estimated Expiration: See Plans and Pricing

Patent: 0160958
Estimated Expiration: See Plans and Pricing

Patent: 0171267
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 16976
Estimated Expiration: See Plans and Pricing

Patent: 18045
Estimated Expiration: See Plans and Pricing

Patent: 19273
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 32792
Estimated Expiration: See Plans and Pricing

Patent: 52930
Estimated Expiration: See Plans and Pricing

Patent: 09923
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 12012282
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 6341
Estimated Expiration: See Plans and Pricing

Patent: 6731
Estimated Expiration: See Plans and Pricing

Patent: 8709
Estimated Expiration: See Plans and Pricing

Patent: 8742
Estimated Expiration: See Plans and Pricing

Patent: 1171417
Estimated Expiration: See Plans and Pricing

Patent: 1290988
Estimated Expiration: See Plans and Pricing

Patent: 1290993
Estimated Expiration: See Plans and Pricing

Patent: 1370186
Estimated Expiration: See Plans and Pricing

Patent: 1592101
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 32792
Estimated Expiration: See Plans and Pricing

Patent: 52930
Estimated Expiration: See Plans and Pricing

Patent: 52931
Estimated Expiration: See Plans and Pricing

Patent: 52933
Estimated Expiration: See Plans and Pricing

Patent: 09923
Estimated Expiration: See Plans and Pricing

Patent: 10264
Estimated Expiration: See Plans and Pricing

Patent: 52422
Estimated Expiration: See Plans and Pricing

Patent: 10562
Estimated Expiration: See Plans and Pricing

Patent: 13337
Estimated Expiration: See Plans and Pricing

Patent: 90428
Estimated Expiration: See Plans and Pricing

Patent: 21275
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 69414
Estimated Expiration: See Plans and Pricing

Patent: 78171
Estimated Expiration: See Plans and Pricing

Patent: 81775
Estimated Expiration: See Plans and Pricing

Patent: 99645
Estimated Expiration: See Plans and Pricing

Patent: 13571
Estimated Expiration: See Plans and Pricing

Patent: 13572
Estimated Expiration: See Plans and Pricing

Patent: 17494
Estimated Expiration: See Plans and Pricing

Patent: 19106
Estimated Expiration: See Plans and Pricing

Patent: 51578
Estimated Expiration: See Plans and Pricing

Patent: 54977
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 26235
Estimated Expiration: See Plans and Pricing

Patent: 31637
Estimated Expiration: See Plans and Pricing

Patent: 34239
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6492
Estimated Expiration: See Plans and Pricing

Patent: 2099
Estimated Expiration: See Plans and Pricing

Patent: 2174
Estimated Expiration: See Plans and Pricing

Patent: 7471
Estimated Expiration: See Plans and Pricing

Patent: 9115
Estimated Expiration: See Plans and Pricing

Japan

Patent: 72539
Estimated Expiration: See Plans and Pricing

Patent: 85659
Estimated Expiration: See Plans and Pricing

Patent: 09535
Estimated Expiration: See Plans and Pricing

Patent: 58528
Estimated Expiration: See Plans and Pricing

Patent: 06716
Estimated Expiration: See Plans and Pricing

Patent: 55605
Estimated Expiration: See Plans and Pricing

Patent: 12527477
Estimated Expiration: See Plans and Pricing

Patent: 13523767
Estimated Expiration: See Plans and Pricing

Patent: 13525277
Estimated Expiration: See Plans and Pricing

Patent: 13527145
Estimated Expiration: See Plans and Pricing

Patent: 15028060
Estimated Expiration: See Plans and Pricing

Patent: 15205903
Estimated Expiration: See Plans and Pricing

Patent: 16053045
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 32792
Estimated Expiration: See Plans and Pricing

Patent: 09923
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 6918
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 0725
Estimated Expiration: See Plans and Pricing

Patent: 11012417
Estimated Expiration: See Plans and Pricing

Patent: 12011171
Estimated Expiration: See Plans and Pricing

Patent: 12011324
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 294
Estimated Expiration: See Plans and Pricing

Patent: 846
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 6635
Estimated Expiration: See Plans and Pricing

Patent: 3232
Estimated Expiration: See Plans and Pricing

Patent: 3602
Estimated Expiration: See Plans and Pricing

Patent: 9926
Estimated Expiration: See Plans and Pricing

Peru

Patent: 130151
Estimated Expiration: See Plans and Pricing

Patent: 130183
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 014502684
Estimated Expiration: See Plans and Pricing

Patent: 015502237
Estimated Expiration: See Plans and Pricing

Poland

Patent: 32792
Estimated Expiration: See Plans and Pricing

Patent: 52930
Estimated Expiration: See Plans and Pricing

Patent: 09923
Estimated Expiration: See Plans and Pricing

Patent: 90428
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 32792
Estimated Expiration: See Plans and Pricing

Patent: 52930
Estimated Expiration: See Plans and Pricing

Patent: 09923
Estimated Expiration: See Plans and Pricing

Patent: 52422
Estimated Expiration: See Plans and Pricing

Patent: 13337
Estimated Expiration: See Plans and Pricing

Patent: 90428
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01500285
Estimated Expiration: See Plans and Pricing

Patent: 01600316
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 368
Estimated Expiration: See Plans and Pricing

Patent: 229
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 6197
Estimated Expiration: See Plans and Pricing

Patent: 4323
Estimated Expiration: See Plans and Pricing

Patent: 4324
Estimated Expiration: See Plans and Pricing

Patent: 201500835W
Estimated Expiration: See Plans and Pricing

Patent: 201702025S
Estimated Expiration: See Plans and Pricing

Patent: 201702294Q
Estimated Expiration: See Plans and Pricing

Patent: 201708263S
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 32792
Estimated Expiration: See Plans and Pricing

Patent: 52930
Estimated Expiration: See Plans and Pricing

Patent: 09923
Estimated Expiration: See Plans and Pricing

Patent: 90428
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1108749
Estimated Expiration: See Plans and Pricing

Patent: 1207799
Estimated Expiration: See Plans and Pricing

Patent: 1207800
Estimated Expiration: See Plans and Pricing

Patent: 1400249
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1599183
Estimated Expiration: See Plans and Pricing

Patent: 1603817
Estimated Expiration: See Plans and Pricing

Patent: 1715981
Estimated Expiration: See Plans and Pricing

Patent: 1759369
Estimated Expiration: See Plans and Pricing

Patent: 120034662
Estimated Expiration: See Plans and Pricing

Patent: 120138242
Estimated Expiration: See Plans and Pricing

Patent: 130064064
Estimated Expiration: See Plans and Pricing

Patent: 140147144
Estimated Expiration: See Plans and Pricing

Patent: 150043553
Estimated Expiration: See Plans and Pricing

Spain

Patent: 16466
Estimated Expiration: See Plans and Pricing

Patent: 51944
Estimated Expiration: See Plans and Pricing

Patent: 86821
Estimated Expiration: See Plans and Pricing

Patent: 38350
Estimated Expiration: See Plans and Pricing

Patent: 44990
Estimated Expiration: See Plans and Pricing

Patent: 48803
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 98117
Estimated Expiration: See Plans and Pricing

Patent: 76352
Estimated Expiration: See Plans and Pricing

Patent: 83692
Estimated Expiration: See Plans and Pricing

Patent: 98358
Estimated Expiration: See Plans and Pricing

Patent: 1107341
Estimated Expiration: See Plans and Pricing

Patent: 1136593
Estimated Expiration: See Plans and Pricing

Patent: 1136945
Estimated Expiration: See Plans and Pricing

Patent: 1139457
Estimated Expiration: See Plans and Pricing

Patent: 1518313
Estimated Expiration: See Plans and Pricing

Patent: 1704249
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 2959
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 310
Estimated Expiration: See Plans and Pricing

Patent: 311
Estimated Expiration: See Plans and Pricing

Patent: 312
Estimated Expiration: See Plans and Pricing

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
Singapore 184323 STEREOSELECTIVE SYNTHESIS OF PHOSPHORUS CONTAINING ACTIVES See Plans and Pricing
Argentina 080870 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 See Plans and Pricing
Canada 2819700 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) See Plans and Pricing
Denmark 2552930 See Plans and Pricing
Eurasian Patent Organization 201490588 СПОСОБЫ ЛЕЧЕНИЯ ВИРУСА ГЕПАТИТА С See Plans and Pricing
Taiwan I498117 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SOVALDI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203462 C20140035 Estonia See Plans and Pricing PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2203462 92600 Luxembourg See Plans and Pricing PRODUCT NAME: SOVALDI (SOFOSBUVIR); AUTHORISATION NUMBER AND DATE: EU/1/13/894(001-002) - SOVALDI - SOFOSBUVIR 20140117
2203462 C20140035 00135 Estonia See Plans and Pricing PRODUCT NAME: SOFOSBUVIIR
2203462 300704 Netherlands See Plans and Pricing PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462 122014000108 Germany See Plans and Pricing PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2635588 C02635588/01 Switzerland See Plans and Pricing PRODUCT NAME: VELPATASVIR + SOFOSBUVIR + VOXILAPREVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66510 08.12.2017
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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