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Last Updated: November 21, 2024

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HARVONI Drug Patent Profile


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Which patents cover Harvoni, and what generic alternatives are available?

Harvoni is a drug marketed by Gilead Sciences Inc and is included in two NDAs. There are seventeen patents protecting this drug.

This drug has five hundred and fifty-five patent family members in forty-eight countries.

The generic ingredient in HARVONI is ledipasvir; sofosbuvir. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ledipasvir; sofosbuvir profile page.

DrugPatentWatch® Generic Entry Outlook for Harvoni

Harvoni was eligible for patent challenges on October 10, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 14, 2032. This may change due to patent challenges or generic licensing.

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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AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for HARVONI?
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Drug patent expirations by year for HARVONI
Drug Prices for HARVONI

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Drug Sales Revenue Trends for HARVONI

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for HARVONI
Generic Entry Dates for HARVONI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
PELLETS;ORAL
Generic Entry Dates for HARVONI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for HARVONI

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

SponsorPhase
Mansoura UniversityPhase 3
Cairo UniversityPhase 2/Phase 3
University of MarylandEarly Phase 1

See all HARVONI clinical trials

US Patents and Regulatory Information for HARVONI

HARVONI is protected by seventeen US patents and seven FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of HARVONI is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting HARVONI

Combination formulation of two antiviral compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods for treating HCV
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antiviral compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antiviral compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidates
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidates
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antiviral compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antiviral compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compositions and methods for treating hepatitis C virus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidate prodrugs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Nucleoside phosphoramidates
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods for treating HCV
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antiviral compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting HARVONI

TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH CHRONIC HCV GENOTYPE 1 INFECTION WITH DECOMPENSATED CIRRHOSIS, FOR USE IN COMBINATION WITH RIBAVIRIN
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF PEDIATRIC PATIENTS BETWEEN 3 YEARS OF AGE AND 12 YEARS OF AGE OR WEIGHING 35 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 4, 5, OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH CHRONIC HCV GENOTYPE 1 OR 4 INFECTION WHO ARE LIVER TRANSPLANT RECIPIENTS WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS, FOR USE IN COMBINATION WITH RIBAVIRIN
Exclusivity Expiration: ⤷  Sign Up

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: ⤷  Sign Up

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: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER OR WEIGHING AT LEAST 35 KG WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 1, 4, 5, OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-002 Aug 28, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir PELLETS;ORAL 212477-002 Aug 28, 2019 RX Yes Yes ⤷  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

International Patents for HARVONI

When does loss-of-exclusivity occur for HARVONI?

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

Argentina

Patent: 8580
Patent: METODOS Y COMPOSICIONES PARA TRATAR EL VIRUS DE LA HEPATITIS C
Estimated Expiration: ⤷  Sign Up

Patent: 9578
Patent: COMPOSICIONES, METODOS PARA TRATAR EL VIRUS DE LA HEPATITIS C Y PROCESO DE PREPARACION
Estimated Expiration: ⤷  Sign Up

Patent: 5131
Patent: FORMULACIÓN COMBINADA DE DOS COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 12308295
Patent: Methods for treating HCV
Estimated Expiration: ⤷  Sign Up

Patent: 12332827
Patent: Methods and compositions for treating hepatitis C virus
Estimated Expiration: ⤷  Sign Up

Patent: 12346217
Patent: Compositions and methods for treating hepatitis C virus
Estimated Expiration: ⤷  Sign Up

Patent: 14202687
Patent: Combination formulation of two antiviral compounds
Estimated Expiration: ⤷  Sign Up

Patent: 15202842
Patent: Combination formulation of two antiviral compounds
Estimated Expiration: ⤷  Sign Up

Patent: 16216641
Patent: Combination formulation of two antiviral compounds
Estimated Expiration: ⤷  Sign Up

Patent: 18203696
Patent: Combination formulation of two antiviral compounds
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2014006324
Patent: método para tratar hcv
Estimated Expiration: ⤷  Sign Up

Patent: 2014010295
Patent: métodos e composições para o tratamento de vírus de hepatite c
Estimated Expiration: ⤷  Sign Up

Patent: 2014011938
Patent: combinação de formulação de dois compostos antivirais
Estimated Expiration: ⤷  Sign Up

Patent: 2014012739
Patent: composições e métodos para o tratamento do vírus da hepatite c
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 40242
Patent: PROCEDES PERMETTANT DE TRAITER LE VIRUS DE L'HEPATITE C (HCV) (METHODS FOR TREATING HCV)
Estimated Expiration: ⤷  Sign Up

Patent: 52867
Patent: COMBINAISON DE FORMULATION DE DEUX COMPOSES ANTIVIRAUX (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 53495
Patent: METHODES ET COMPOSITIONS POUR LE TRAITEMENT DU VIRUS DE L'HEPATITE C (METHODS AND COMPOSITIONS FOR TREATING HEPATITIS C VIRUS)
Estimated Expiration: ⤷  Sign Up

Patent: 56529
Patent: COMPOSITIONS ET METHODES POUR TRAITER LE VIRUS DE L'HEPATITE C (COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 14000630
Patent: Una composicion que comprende 1) un compuesto derivado de nucleosido denominado como compuesto 10 y 2) un compuesto derivado de acido 5-tiofeno-2-carboxilico denominado como compuesto 5 o un compuesto derivado del ester metilico del acido carbamico denominado como compuesto 6; y su uso para el tratamiento profilactico o terapeutico de una infeccion por vhc.
Estimated Expiration: ⤷  Sign Up

Patent: 14001397
Patent: Composicion farmaceutica que comprende a) gs-7977 y b) al menos un excipiente farmaceuticamente estable; forma de dosificacion unitaria; proceso de preparacion de la composicion; uso de la composicion para tratar una infeccion causada por el virus de la hepatitis c.
Estimated Expiration: ⤷  Sign Up

Patent: 15002164
Patent: Formulación combinada de dos compuesos antivirales.
Estimated Expiration: ⤷  Sign Up

China

Patent: 4039319
Patent: Compositions and methods for treating hepatitis c virus
Estimated Expiration: ⤷  Sign Up

Patent: 4144682
Patent: Combination formulation of two antiviral compounds
Estimated Expiration: ⤷  Sign Up

Patent: 4244945
Patent: METHODS FOR TREATING HCV
Estimated Expiration: ⤷  Sign Up

Patent: 4244947
Patent: METHODS AND COMPOSITIONS FOR TREATING HEPATITIS C VIRUS
Estimated Expiration: ⤷  Sign Up

Patent: 5748499
Patent: 两个抗病毒化合物的联用制剂 (Combination formulation of two antiviral compounds)
Estimated Expiration: ⤷  Sign Up

Patent: 6166160
Patent: 用于治疗HCV的组合物 (Composition for treating HCV)
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 30366
Patent: Método para el tratamiento de vhc
Estimated Expiration: ⤷  Sign Up

Patent: 70603
Patent: Composiciones y métodos para tratar el virus de la hepatitis c
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 140177
Patent: MÉTODOS PARA EL TRATAMIENTO DE VHC
Estimated Expiration: ⤷  Sign Up

Patent: 140273
Patent: COMPOSICIONES Y MÉTODOS PARA TRATAR EL VIRUS DE LA HEPATITIS C
Estimated Expiration: ⤷  Sign Up

Patent: 150453
Patent: FORMULACIÓN COMBINADA DE DOS COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0180237
Estimated Expiration: ⤷  Sign Up

Patent: 0200138
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 19896
Estimated Expiration: ⤷  Sign Up

Patent: 22718
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 09613
Estimated Expiration: ⤷  Sign Up

Patent: 50786
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 14005678
Patent: COMPOSICIONES Y MÉTODOS PARA TRATAR EL VIRUS DE LA HEPATITIS C
Estimated Expiration: ⤷  Sign Up

Patent: 14013312
Patent: COMPOSICIONES PARA EL TRATAMIENTO DE VHC
Estimated Expiration: ⤷  Sign Up

Patent: 15037311
Patent: FORMULACIÓN COMBINADA DE DOS COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Sign Up

Patent: 21087299
Patent: COMPOSICIONES Y MÉTODOS PARA TRATAR EL VIRUS DE LA HEPATITIS C
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 6667
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ЛЕЧЕНИЯ ВИРУСА ГЕПАТИТА С (PHARMACEUTICAL COMPOSITION FOR TREATING HEPATITIS C VIRUS)
Estimated Expiration: ⤷  Sign Up

Patent: 7296
Patent: КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ВИРУСНОГО ГЕПАТИТА C (COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS)
Estimated Expiration: ⤷  Sign Up

Patent: 9081
Patent: КОМБИНИРОВАННЫЙ СОСТАВ ДВУХ ПРОТИВОВИРУСНЫХ СОЕДИНЕНИЙ (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 1490588
Patent: СПОСОБЫ ЛЕЧЕНИЯ ВИРУСА ГЕПАТИТА С
Estimated Expiration: ⤷  Sign Up

Patent: 1490806
Patent: КОМБИНИРОВАННЫЙ СОСТАВ ДВУХ ПРОТИВОВИРУСНЫХ СОЕДИНЕНИЙ
Estimated Expiration: ⤷  Sign Up

Patent: 1490903
Patent: КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ВИРУСНОГО ГЕПАТИТА C
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 09613
Patent: PROCÉDÉS PERMETTANT DE TRAITER LE VIRUS DE L'HÉPATITE C (HCV) (METHODS FOR TREATING HCV)
Estimated Expiration: ⤷  Sign Up

Patent: 76024
Patent: MÉTHODES ET COMPOSITIONS POUR LE TRAITEMENT DU VIRUS DE L'HÉPATITE C (METHODS AND COMPOSITIONS FOR TREATING HEPATITIS C VIRUS)
Estimated Expiration: ⤷  Sign Up

Patent: 85340
Patent: COMPOSITIONS ET MÉTHODES POUR TRAITER LE VIRUS DE L'HÉPATITE C (COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS)
Estimated Expiration: ⤷  Sign Up

Patent: 50786
Patent: FORMULATION DE COMBINAISON DE DEUX COMPOSÉS ANTIVIRAUX (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 50013
Patent: FORMULATION DE COMBINAISON DE DEUX COMPOSÉS ANTIVIRAUX (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 77867
Patent: COMPOSITION ET PROCÉDÉS POUR LE TRAITEMENT DU VIRUS DE L'HÉPATITE C (COMPOSITION AND METHODS FOR TREATING HEPATITIS C VIRUS)
Estimated Expiration: ⤷  Sign Up

Germany

Patent: 2012013074
Estimated Expiration: ⤷  Sign Up

Patent: 2012013382
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 02268
Patent: 用於治療 的組合物和方法 (COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS HCV)
Estimated Expiration: ⤷  Sign Up

Patent: 19869
Patent: 兩個抗病毒化合物的聯用製劑 (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 31378
Patent: 用於治療 的組合物 (COMPOSITION FOR TREATING HCV HCV)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 36588
Estimated Expiration: ⤷  Sign Up

Patent: 47777
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 1515
Patent: תכשירים לטיפול בוירוס הפטיטיס סי (Compositions for treating hcv)
Estimated Expiration: ⤷  Sign Up

Patent: 2889
Patent: Gi7977 ושימושים שלו בטיפול בנגיף הפטיטיס c (Gi7977 and uses thereof in treating hepatitis c virus)
Estimated Expiration: ⤷  Sign Up

Patent: 3419
Patent: פורמולציה משולבת של שתי תרכובות אנטי-ויראליות (Combination formulation of two antiviral compounds)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 99327
Estimated Expiration: ⤷  Sign Up

Patent: 73897
Estimated Expiration: ⤷  Sign Up

Patent: 23002
Estimated Expiration: ⤷  Sign Up

Patent: 20994
Estimated Expiration: ⤷  Sign Up

Patent: 14526516
Estimated Expiration: ⤷  Sign Up

Patent: 14532657
Patent: C型肝炎ウイルスを処置するための方法および組成物
Estimated Expiration: ⤷  Sign Up

Patent: 14533733
Patent: C型肝炎ウイルスを処置するための組成物および方法
Estimated Expiration: ⤷  Sign Up

Patent: 15508418
Patent: 2種の抗ウイルス化合物のコンビナトリアル製剤
Estimated Expiration: ⤷  Sign Up

Patent: 16053096
Patent: C型肝炎ウイルスを処置するための組成物および方法 (COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS)
Estimated Expiration: ⤷  Sign Up

Patent: 16155875
Patent: 2種の抗ウイルス化合物のコンビナトリアル製剤 (COMBINATORIAL FORMULATION OF TWO KINDS OF ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 16166251
Patent: 2種の抗ウイルス化合物のコンビナトリアル製剤 (COMBINATORIAL FORMULATION OF TWO KINDS OF ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 17057230
Patent: HCVを処置するための方法 (METHOD FOR TREATING HCV)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 09613
Estimated Expiration: ⤷  Sign Up

Patent: 50786
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 2166
Patent: COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Patent: 7735
Patent: COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 6580
Patent: METODOS PARA EL TRATAMIENTO DE VHC. (METHODS FOR TREATING HCV.)
Estimated Expiration: ⤷  Sign Up

Patent: 1816
Patent: FORMULACION DE COMBINACION DE DOS COMPUESTOS ANTIVIRALES. (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS.)
Estimated Expiration: ⤷  Sign Up

Patent: 4958
Patent: METODOS PARA EL TRATAMIENTO DE VHC. (METHODS FOR TREATING HCV.)
Estimated Expiration: ⤷  Sign Up

Patent: 14003145
Patent: METODOS PARA EL TRATAMIENTO DE VHC. (METHODS FOR TREATING HCV.)
Estimated Expiration: ⤷  Sign Up

Patent: 14005955
Patent: FORMULACION DE COMBINACION DE DOS COMPUESTOS ANTIVIRALES. (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS.)
Estimated Expiration: ⤷  Sign Up

Patent: 14006373
Patent: COMPOSICIONES Y METODOS PARA TRATAR EL VIRUS DE LA HEPATITIS C. (COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS.)
Estimated Expiration: ⤷  Sign Up

Moldova, Republic of

Patent: 30
Patent: Compoziţii şi metode de tratament al hepatitei virale C (Compositions and methods for treating hepatitis C virus)
Estimated Expiration: ⤷  Sign Up

Patent: 89
Patent: Compoziţie farmaceutică cu conţinut de sofosbuvir şi utilizarea acesteia în tratamentul hepatitei virale C (Pharmaceutical composition comprising sofosbuvir and uses thereof for treating hepatitis C virus)
Estimated Expiration: ⤷  Sign Up

Patent: 95
Patent: Tabletă combinată conţinând doi compuşi antivirali (Combination formulation of two antiviral compounds)
Estimated Expiration: ⤷  Sign Up

Patent: 140035
Patent: Metodă de tratament al hepatitei virale C (Method for treating hepatitis C virus)
Estimated Expiration: ⤷  Sign Up

Patent: 140058
Patent: Compoziţii şi metode de tratament al hepatitei virale C (Compositions and methods for treating hepatitis C virus)
Estimated Expiration: ⤷  Sign Up

Patent: 150080
Patent: Compoziţie combinată de doi compuşi antivirali (Combination formulation of two antiviral compounds)
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 009
Patent: METODE ZA LECENJE HCV-A (METHODS FOR TREATING HCV)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 906
Patent: Procédés permettant de traiter le virus de l'hépatite c (hcv)
Estimated Expiration: ⤷  Sign Up

Patent: 150030
Patent: Compositions et méthodes pour traiter le virus de l'hépatite c
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 3396
Patent: Methods for treating hcv
Estimated Expiration: ⤷  Sign Up

Patent: 5087
Patent: Combination formulation of two antiviral compounds
Estimated Expiration: ⤷  Sign Up

Patent: 5532
Patent: Compositions and methods for treating hepatitis c virus
Estimated Expiration: ⤷  Sign Up

Patent: 0391
Patent: Methods for treating hcv
Estimated Expiration: ⤷  Sign Up

Patent: 9172
Patent: Combination formulation of two antiviral compounds
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 141056
Patent: METODOS PARA EL TRATAMIENTO DE VHC
Estimated Expiration: ⤷  Sign Up

Patent: 141296
Patent: COMPOSICIONES Y METODOS PARA TRATAR EL VIRUS DE LA HEPATITIS C
Estimated Expiration: ⤷  Sign Up

Patent: 151778
Patent: FORMULACION COMBINADA DE DOS COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 014501133
Patent: COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS
Estimated Expiration: ⤷  Sign Up

Patent: 015501710
Patent: COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 09613
Estimated Expiration: ⤷  Sign Up

Patent: 50786
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 09613
Estimated Expiration: ⤷  Sign Up

Patent: 50786
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 975
Patent: METODE ZA LEČENJE HCV-A (METHODS FOR TREATING HCV)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201602044W
Patent: Methods For Treating HCV
Estimated Expiration: ⤷  Sign Up

Patent: 201706949V
Patent: COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Patent: 201400664W
Patent: METHODS FOR TREATING HCV
Estimated Expiration: ⤷  Sign Up

Patent: 201402609R
Patent: COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS
Estimated Expiration: ⤷  Sign Up

Patent: 201506021X
Patent: COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 09613
Estimated Expiration: ⤷  Sign Up

Patent: 50786
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1404061
Patent: COMPOSITIONS AND METHODS FOR TREATING THE HEPATITIS C VIRUS
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1560994
Estimated Expiration: ⤷  Sign Up

Patent: 1962522
Estimated Expiration: ⤷  Sign Up

Patent: 1991298
Estimated Expiration: ⤷  Sign Up

Patent: 140096029
Patent: METHODS FOR TREATING HCV
Estimated Expiration: ⤷  Sign Up

Patent: 140108645
Patent: COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS
Estimated Expiration: ⤷  Sign Up

Patent: 140119012
Patent: COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Patent: 160052797
Patent: 두 항바이러스 화합물의 병용 제형물 (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS)
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Patent: 190033643
Patent: 두 항바이러스 화합물의 병용 제형물 (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS)
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Patent: 190075142
Patent: HCV 치료 방법 (HCV METHODS FOR TREATING HCV)
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Patent: 200060782
Patent: 두 항바이러스 화합물의 병용 제형물 (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS)
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Spain

Patent: 59216
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Patent: 71458
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Patent: 17886
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Taiwan

Patent: 66773
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Patent: 26047
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Patent: 1318627
Patent: Methods and compositions for treating hepatitis C virus
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Patent: 1325599
Patent: Compositions and methods for treating hepatitis C virus
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Patent: 1444556
Patent: Combination formulation of two antiviral compounds
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Patent: 1840311
Patent: Combination formulation of two antiviral compounds
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Patent: 2042808
Patent: Combination formulation of two antiviral compounds
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Turkey

Patent: 1802537
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Ukraine

Patent: 4097
Patent: КОМПОЗИЦІЯ (ВАРІАНТИ) ТА СПОСІБ (ВАРІАНТИ) ЛІКУВАННЯ ВІРУСНОГО ГЕПАТИТУ С
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Patent: 6087
Patent: КОМПОЗИЦІЯ ДЛЯ ЛІКУВАННЯ ВІРУСУ ГЕПАТИТУ C (METHODS FOR TREATING HCV)
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Patent: 8256
Patent: КОМБІНОВАНИЙ СКЛАД ДВОХ ПРОТИВІРУСНИХ СПОЛУК (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS)
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Uruguay

Patent: 420
Patent: ?MÉTODOS DE TRATAMIENTO DEL VIRUS DE LA HEPATITIS C CON QUE DE GS-7977 Y RIBAVIRINA, COMPOSICIONES Y USOS"
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Patent: 474
Patent: Composiciones, forma de dosificación y métodos para tratar el virus de la hepatitis C.
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Patent: 299
Patent: FORMULACIÓN COMBINADA DE DOS COMPUESTOS ANTIVIRALES
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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 HARVONI around the world.

Country Patent Number Title Estimated Expiration
South Korea 101546119 ⤷  Sign Up
Cyprus 1118045 ⤷  Sign Up
Australia 2011235044 Stereoselective synthesis of phosphorus containing actives ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for HARVONI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2430014 PA2016002 Lithuania ⤷  Sign Up PRODUCT NAME: LEDIPASVIRAS; REGISTRATION NO/DATE: EU/1/14/958(001-002) 20141118
2203462 1491066-5 Sweden ⤷  Sign Up PRODUCT NAME: SOFOSBUVIR; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/13/894, 2014-01-17
2430014 2020046 Norway ⤷  Sign Up PRODUCT NAME: LEDIPASVIR - FORLENGET SPC; REG. NO/DATE: EU/1/14/958 20141203
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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