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Last Updated: July 12, 2025

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 sixty-one patent family members in forty-nine 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 two 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 Deep Research
Questions you can ask:
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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 Maryland, College ParkEarly Phase 1

See all HARVONI clinical trials

US Patents and Regulatory Information for HARVONI

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

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

This potential generic entry date is based on patent ⤷  Try for Free.

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

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 ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-002 Aug 28, 2019 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir PELLETS;ORAL 212477-002 Aug 28, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-002 Aug 28, 2019 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-002 Aug 28, 2019 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>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: ⤷  Try for Free

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

Patent: 5131
Patent: FORMULACIÓN COMBINADA DE DOS COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Try for Free

Patent: 0558
Patent: COMPOSICIÓN FARMACÉUTICA QUE COMPRENDE LEDIPASVIR Y SOFOSBUVIR, FORMA DE DOSIFICACIÓN FARMACÉUTICA Y COMPRIMIDO QUE LA COMPRENDEN
Estimated Expiration: ⤷  Try for Free

Australia

Patent: 12308295
Patent: Methods for treating HCV
Estimated Expiration: ⤷  Try for Free

Patent: 12332827
Patent: Methods and compositions for treating hepatitis C virus
Estimated Expiration: ⤷  Try for Free

Patent: 12346217
Patent: Compositions and methods for treating hepatitis C virus
Estimated Expiration: ⤷  Try for Free

Patent: 14202687
Patent: Combination formulation of two antiviral compounds
Estimated Expiration: ⤷  Try for Free

Patent: 15202842
Patent: Combination formulation of two antiviral compounds
Estimated Expiration: ⤷  Try for Free

Patent: 16216641
Patent: Combination formulation of two antiviral compounds
Estimated Expiration: ⤷  Try for Free

Patent: 18203696
Patent: Combination formulation of two antiviral compounds
Estimated Expiration: ⤷  Try for Free

Brazil

Patent: 2014006324
Patent: método para tratar hcv
Estimated Expiration: ⤷  Try for Free

Patent: 2014010295
Patent: métodos e composições para o tratamento de vírus de hepatite c
Estimated Expiration: ⤷  Try for Free

Patent: 2014011938
Patent: combinação de formulação de dois compostos antivirais
Estimated Expiration: ⤷  Try for Free

Patent: 2014012739
Patent: composições e métodos para o tratamento do vírus da hepatite c
Estimated Expiration: ⤷  Try for Free

Canada

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

Patent: 52867
Patent: COMBINAISON DE FORMULATION DE DEUX COMPOSES ANTIVIRAUX (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Try for Free

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: ⤷  Try for Free

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

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: ⤷  Try for Free

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: ⤷  Try for Free

Patent: 15002164
Patent: Formulación combinada de dos compuesos antivirales.
Estimated Expiration: ⤷  Try for Free

China

Patent: 4039319
Patent: Compositions and methods for treating hepatitis c virus
Estimated Expiration: ⤷  Try for Free

Patent: 4144682
Patent: Combination formulation of two antiviral compounds
Estimated Expiration: ⤷  Try for Free

Patent: 4244945
Patent: METHODS FOR TREATING HCV
Estimated Expiration: ⤷  Try for Free

Patent: 4244947
Patent: METHODS AND COMPOSITIONS FOR TREATING HEPATITIS C VIRUS
Estimated Expiration: ⤷  Try for Free

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

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

Colombia

Patent: 30366
Patent: Método para el tratamiento de vhc
Estimated Expiration: ⤷  Try for Free

Patent: 70603
Patent: Composiciones y métodos para tratar el virus de la hepatitis c
Estimated Expiration: ⤷  Try for Free

Costa Rica

Patent: 140177
Patent: MÉTODOS PARA EL TRATAMIENTO DE VHC
Estimated Expiration: ⤷  Try for Free

Patent: 140273
Patent: COMPOSICIONES Y MÉTODOS PARA TRATAR EL VIRUS DE LA HEPATITIS C
Estimated Expiration: ⤷  Try for Free

Patent: 150453
Patent: FORMULACIÓN COMBINADA DE DOS COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Try for Free

Croatia

Patent: 0180237
Estimated Expiration: ⤷  Try for Free

Patent: 0200138
Estimated Expiration: ⤷  Try for Free

Cyprus

Patent: 19896
Estimated Expiration: ⤷  Try for Free

Patent: 22718
Estimated Expiration: ⤷  Try for Free

Denmark

Patent: 09613
Estimated Expiration: ⤷  Try for Free

Patent: 50786
Estimated Expiration: ⤷  Try for Free

Ecuador

Patent: 14005678
Patent: COMPOSICIONES Y MÉTODOS PARA TRATAR EL VIRUS DE LA HEPATITIS C
Estimated Expiration: ⤷  Try for Free

Patent: 14013312
Patent: COMPOSICIONES PARA EL TRATAMIENTO DE VHC
Estimated Expiration: ⤷  Try for Free

Patent: 15037311
Patent: FORMULACIÓN COMBINADA DE DOS COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Try for Free

Patent: 21087299
Patent: COMPOSICIONES Y MÉTODOS PARA TRATAR EL VIRUS DE LA HEPATITIS C
Estimated Expiration: ⤷  Try for Free

Eurasian Patent Organization

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

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

Patent: 9081
Patent: КОМБИНИРОВАННЫЙ СОСТАВ ДВУХ ПРОТИВОВИРУСНЫХ СОЕДИНЕНИЙ (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Try for Free

Patent: 1490588
Patent: СПОСОБЫ ЛЕЧЕНИЯ ВИРУСА ГЕПАТИТА С
Estimated Expiration: ⤷  Try for Free

Patent: 1490806
Patent: КОМБИНИРОВАННЫЙ СОСТАВ ДВУХ ПРОТИВОВИРУСНЫХ СОЕДИНЕНИЙ
Estimated Expiration: ⤷  Try for Free

Patent: 1490903
Patent: КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ВИРУСНОГО ГЕПАТИТА C
Estimated Expiration: ⤷  Try for Free

European Patent Office

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

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: ⤷  Try for Free

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

Patent: 50786
Patent: FORMULATION DE COMBINAISON DE DEUX COMPOSÉS ANTIVIRAUX (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Try for Free

Patent: 50013
Patent: FORMULATION DE COMBINAISON DE DEUX COMPOSÉS ANTIVIRAUX (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Try for Free

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: ⤷  Try for Free

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: ⤷  Try for Free

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

Patent: 31378
Patent: 用於治療 的組合物 (COMPOSITION FOR TREATING HCV HCV)
Estimated Expiration: ⤷  Try for Free

Hungary

Patent: 36588
Estimated Expiration: ⤷  Try for Free

Patent: 47777
Estimated Expiration: ⤷  Try for Free

Israel

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

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

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

Japan

Patent: 99327
Estimated Expiration: ⤷  Try for Free

Patent: 73897
Estimated Expiration: ⤷  Try for Free

Patent: 23002
Estimated Expiration: ⤷  Try for Free

Patent: 20994
Estimated Expiration: ⤷  Try for Free

Patent: 14526516
Estimated Expiration: ⤷  Try for Free

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: ⤷  Try for Free

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: ⤷  Try for Free

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: ⤷  Try for Free

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: ⤷  Try for Free

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: ⤷  Try for Free

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: ⤷  Try for Free

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

Lithuania

Patent: 09613
Estimated Expiration: ⤷  Try for Free

Patent: 50786
Estimated Expiration: ⤷  Try for Free

Malaysia

Patent: 2166
Patent: COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS
Estimated Expiration: ⤷  Try for Free

Patent: 7735
Patent: COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS
Estimated Expiration: ⤷  Try for Free

Mexico

Patent: 6580
Patent: METODOS PARA EL TRATAMIENTO DE VHC. (METHODS FOR TREATING HCV.)
Estimated Expiration: ⤷  Try for Free

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

Patent: 4958
Patent: METODOS PARA EL TRATAMIENTO DE VHC. (METHODS FOR TREATING HCV.)
Estimated Expiration: ⤷  Try for Free

Patent: 14003145
Patent: METODOS PARA EL TRATAMIENTO DE VHC. (METHODS FOR TREATING HCV.)
Estimated Expiration: ⤷  Try for Free

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

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

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: ⤷  Try for Free

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: ⤷  Try for Free

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

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

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

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

Montenegro

Patent: 009
Patent: METODE ZA LECENJE HCV-A (METHODS FOR TREATING HCV)
Estimated Expiration: ⤷  Try for Free

Morocco

Patent: 906
Patent: Procédés permettant de traiter le virus de l'hépatite c (hcv)
Estimated Expiration: ⤷  Try for Free

Patent: 150030
Patent: Compositions et méthodes pour traiter le virus de l'hépatite c
Estimated Expiration: ⤷  Try for Free

New Zealand

Patent: 3396
Patent: Methods for treating hcv
Estimated Expiration: ⤷  Try for Free

Patent: 5087
Patent: Combination formulation of two antiviral compounds
Estimated Expiration: ⤷  Try for Free

Patent: 5532
Patent: Compositions and methods for treating hepatitis c virus
Estimated Expiration: ⤷  Try for Free

Patent: 0391
Patent: Methods for treating hcv
Estimated Expiration: ⤷  Try for Free

Patent: 9172
Patent: Combination formulation of two antiviral compounds
Estimated Expiration: ⤷  Try for Free

Peru

Patent: 141056
Patent: METODOS PARA EL TRATAMIENTO DE VHC
Estimated Expiration: ⤷  Try for Free

Patent: 141296
Patent: COMPOSICIONES Y METODOS PARA TRATAR EL VIRUS DE LA HEPATITIS C
Estimated Expiration: ⤷  Try for Free

Patent: 151778
Patent: FORMULACION COMBINADA DE DOS COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Try for Free

Philippines

Patent: 014501133
Patent: COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS
Estimated Expiration: ⤷  Try for Free

Patent: 015501710
Patent: COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS
Estimated Expiration: ⤷  Try for Free

Poland

Patent: 09613
Estimated Expiration: ⤷  Try for Free

Patent: 50786
Estimated Expiration: ⤷  Try for Free

Portugal

Patent: 09613
Estimated Expiration: ⤷  Try for Free

Patent: 50786
Estimated Expiration: ⤷  Try for Free

Serbia

Patent: 975
Patent: METODE ZA LEČENJE HCV-A (METHODS FOR TREATING HCV)
Estimated Expiration: ⤷  Try for Free

Singapore

Patent: 201602044W
Patent: Methods For Treating HCV
Estimated Expiration: ⤷  Try for Free

Patent: 201706949V
Patent: COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS
Estimated Expiration: ⤷  Try for Free

Patent: 201400664W
Patent: METHODS FOR TREATING HCV
Estimated Expiration: ⤷  Try for Free

Patent: 201402609R
Patent: COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS
Estimated Expiration: ⤷  Try for Free

Patent: 201506021X
Patent: COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS
Estimated Expiration: ⤷  Try for Free

Slovenia

Patent: 09613
Estimated Expiration: ⤷  Try for Free

Patent: 50786
Estimated Expiration: ⤷  Try for Free

South Africa

Patent: 1404061
Patent: COMPOSITIONS AND METHODS FOR TREATING THE HEPATITIS C VIRUS
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 1560994
Estimated Expiration: ⤷  Try for Free

Patent: 1962522
Estimated Expiration: ⤷  Try for Free

Patent: 1991298
Estimated Expiration: ⤷  Try for Free

Patent: 140096029
Patent: METHODS FOR TREATING HCV
Estimated Expiration: ⤷  Try for Free

Patent: 140108645
Patent: COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS
Estimated Expiration: ⤷  Try for Free

Patent: 140119012
Patent: COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS
Estimated Expiration: ⤷  Try for Free

Patent: 160052797
Patent: 두 항바이러스 화합물의 병용 제형물 (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Try for Free

Patent: 190033643
Patent: 두 항바이러스 화합물의 병용 제형물 (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Try for Free

Patent: 190075142
Patent: HCV 치료 방법 (HCV METHODS FOR TREATING HCV)
Estimated Expiration: ⤷  Try for Free

Patent: 200060782
Patent: 두 항바이러스 화합물의 병용 제형물 (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 59216
Estimated Expiration: ⤷  Try for Free

Patent: 71458
Estimated Expiration: ⤷  Try for Free

Patent: 17886
Estimated Expiration: ⤷  Try for Free

Taiwan

Patent: 66773
Estimated Expiration: ⤷  Try for Free

Patent: 26047
Estimated Expiration: ⤷  Try for Free

Patent: 1318627
Patent: Methods and compositions for treating hepatitis C virus
Estimated Expiration: ⤷  Try for Free

Patent: 1325599
Patent: Compositions and methods for treating hepatitis C virus
Estimated Expiration: ⤷  Try for Free

Patent: 1444556
Patent: Combination formulation of two antiviral compounds
Estimated Expiration: ⤷  Try for Free

Patent: 1840311
Patent: Combination formulation of two antiviral compounds
Estimated Expiration: ⤷  Try for Free

Patent: 2042808
Patent: Combination formulation of two antiviral compounds
Estimated Expiration: ⤷  Try for Free

Turkey

Patent: 1802537
Estimated Expiration: ⤷  Try for Free

Ukraine

Patent: 4097
Patent: КОМПОЗИЦІЯ (ВАРІАНТИ) ТА СПОСІБ (ВАРІАНТИ) ЛІКУВАННЯ ВІРУСНОГО ГЕПАТИТУ С
Estimated Expiration: ⤷  Try for Free

Patent: 6087
Patent: КОМПОЗИЦІЯ ДЛЯ ЛІКУВАННЯ ВІРУСУ ГЕПАТИТУ C (METHODS FOR TREATING HCV)
Estimated Expiration: ⤷  Try for Free

Patent: 8256
Patent: КОМБІНОВАНИЙ СКЛАД ДВОХ ПРОТИВІРУСНИХ СПОЛУК (COMBINATION FORMULATION OF TWO ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Try for Free

Uruguay

Patent: 420
Patent: ?MÉTODOS DE TRATAMIENTO DEL VIRUS DE LA HEPATITIS C CON QUE DE GS-7977 Y RIBAVIRINA, COMPOSICIONES Y USOS"
Estimated Expiration: ⤷  Try for Free

Patent: 474
Patent: Composiciones, forma de dosificación y métodos para tratar el virus de la hepatitis C.
Estimated Expiration: ⤷  Try for Free

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
Moldova, Republic of 20140058 Compoziţii şi metode de tratament al hepatitei virale C (Compositions and methods for treating hepatitis C virus) ⤷  Try for Free
South Korea 101991298 ⤷  Try for Free
Eurasian Patent Organization 027493 ПРОМЕЖУТОЧНЫЕ СОЕДИНЕНИЯ ДЛЯ ПОЛУЧЕНИЯ ПРОТИВОВИРУСНОГО СОЕДИНЕНИЯ (INTERMEDIATES FOR PREPARING AN ANTIVIRAL COMPOUND) ⤷  Try for Free
Eurasian Patent Organization 037281 СПОСОБЫ ПОЛУЧЕНИЯ ПРОТИВОВИРУСНОГО СОЕДИНЕНИЯ (METHODS OF PREPARING AN ANTIVIRAL COMPOUND) ⤷  Try for Free
Croatia P20200138 ⤷  Try for Free
Taiwan 201107341 Nucleoside phosphoramidates ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for HARVONI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2430014 2016C/006 Belgium ⤷  Try for Free PRODUCT NAME: LEDIPASVIR/SOFOSBUVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/958 20141118
2430014 122016000009 Germany ⤷  Try for Free PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141117
2430014 232 5001-2016 Slovakia ⤷  Try for Free PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141118
2203462 300704 Netherlands ⤷  Try for Free PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2430014 CR 2016 00006 Denmark ⤷  Try for Free PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958/001-002 20141118
2430014 4/2016 Austria ⤷  Try for Free PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 (MITTEILUNG) 20141118
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Harvoni

Last updated: July 3, 2025

Introduction

Harvoni, a groundbreaking treatment for hepatitis C virus (HCV), has reshaped the pharmaceutical landscape since its launch. Developed by Gilead Sciences, this fixed-dose combination of ledipasvir and sofosbuvir delivers cure rates exceeding 90% for certain genotypes, transforming chronic liver disease management. As global demand for effective antiviral therapies rises, understanding Harvoni's market dynamics and financial path equips business professionals with critical insights for investment and strategic decisions in the biotech sector.

Overview of Harvoni

Harvoni stands as a pivotal innovation in antiviral medicine, targeting HCV genotypes 1, 4, 5, and 6 in adults. Gilead Sciences received U.S. Food and Drug Administration (FDA) approval for Harvoni in October 2014, marking a leap from interferon-based treatments to direct-acting antivirals. The drug inhibits viral replication by blocking the NS5A protein and the HCV NS5B polymerase, enabling shorter treatment durations—often just 8 to 12 weeks—with minimal side effects.

This efficacy has driven widespread adoption, particularly in high-burden regions like the U.S. and Europe. However, Harvoni's high initial pricing, around $84,000 for a 12-week course in the U.S., sparked debates on accessibility and value-based pricing. Despite these challenges, the drug's success underscores the potential for rapid market penetration in unmet medical needs, with global sales peaking at over $13 billion in 2015 alone.

Market Dynamics of Harvoni

The hepatitis C market has evolved rapidly, with Harvoni commanding a significant share amid fierce competition. In 2023, the global HCV treatment market reached approximately $7 billion, driven by rising awareness and screening programs in developing countries [1]. Harvoni's market dominance stems from its all-oral regimen and high cure rates, but generics and alternative therapies now pressure its position.

Key competitors include AbbVie's Mavyret, which offers shorter treatment courses for a broader range of genotypes, and Gilead's own Epclusa. These drugs have eroded Harvoni's market share, particularly in price-sensitive markets. For instance, in Europe, generics entered after patent expirations, reducing Harvoni's share from 60% in 2016 to under 40% by 2022 [2]. Regulatory factors, such as the World Health Organization's push for affordable HCV treatments, further influence dynamics, promoting biosimilars in low-income regions.

Pricing strategies play a crucial role. Gilead has negotiated rebates and value-based agreements in the U.S., linking costs to patient outcomes. Globally, tiered pricing models have expanded access in emerging markets, yet controversies persist. A 2021 study highlighted that Harvoni's list price in India dropped to under $900 per course due to local manufacturing licenses, illustrating how intellectual property agreements shape market entry [3].

Economic factors, including healthcare budget constraints post-COVID-19, have tempered growth. Demand remains strong in aging populations with higher HCV prevalence, but supply chain disruptions have intermittently affected distribution. Analysts project the market to grow at a compound annual growth rate (CAGR) of 4% through 2028, fueled by expanded screening in Asia-Pacific regions [4].

Patent Landscape and Its Impact

Harvoni's intellectual property framework has been a double-edged sword, securing Gilead's exclusivity while inviting challenges. The core patents for ledipasvir and sofosbuvir, granted in the early 2010s, began expiring in 2019 in the U.S. and Europe. This opened the door for generic versions, with companies like Aurobindo Pharma launching affordable alternatives in India and other markets by 2020.

Legal battles have defined this phase. Gilead successfully defended against several patent infringements, including a high-profile case in 2017 where the company settled with generic manufacturers to delay competition [5]. However, in 2022, the European Patent Office revoked a key sofosbuvir patent, accelerating generic penetration. This shift has compressed Harvoni's premium pricing window, forcing Gilead to pivot toward combination therapies and pipeline innovations.

The patent landscape directly influences market dynamics, as generics now capture 30-50% of the HCV market in developed regions. Business professionals monitoring this space should note that ongoing patent reforms, such as the U.S. Patent and Trademark Office's inter partes review processes, could further erode barriers, emphasizing the need for diversified portfolios in pharmaceutical investments.

Financial Trajectory of Harvoni

Gilead's financial performance with Harvoni reflects a classic blockbuster trajectory: explosive growth followed by decline. Launched in 2014, the drug generated $13.9 billion in global sales by 2015, contributing over 50% to Gilead's revenue that year. By 2023, however, sales had plummeted to $2.5 billion, a 82% drop from its peak, driven by patent expirations and generic competition [6].

Revenue trends show a clear pattern: rapid ascent through 2016, stabilization amid pricing pressures, and descent post-2019. In the U.S., net sales fell from $9.1 billion in 2019 to $1.8 billion in 2023, as insurers favored lower-cost options. Internationally, ex-U.S. sales held steadier, thanks to partnerships like those with generic manufacturers under voluntary licensing agreements, which generated royalties but diluted direct profits.

Profitability metrics reveal resilience. Harvoni maintained gross margins above 80% during its exclusivity period, bolstering Gilead's cash flow for R&D investments. By 2023, the drug's contribution margin had declined, but Gilead offset this through acquisitions and new launches, such as Biktarvy for HIV. Financial projections from analysts at firms like Barclays estimate Harvoni's revenue to stabilize at $1-2 billion annually through 2025, with potential upside from emerging markets [7].

Investor sentiment hinges on this trajectory. While Harvoni's decline signals risks in mono-product reliance, it highlights opportunities in Gilead's broader pipeline, including oncology and HIV therapies. Stock performance data shows Gilead's shares dipped 15% in 2022 amid HCV sales warnings, but rebounded as the company diversified [8].

Future Outlook and Strategic Considerations

Looking ahead, Harvoni's financial path depends on global health trends and innovation. The HCV market is expected to contract slightly as eradication efforts succeed, but residual demand in underserved regions could sustain Harvoni's role. Gilead is adapting by bundling Harvoni with diagnostics or combining it in new regimens, potentially extending its lifecycle.

Strategic risks include regulatory scrutiny on pricing and geopolitical supply issues. Opportunities lie in personalized medicine, where Harvoni could integrate with AI-driven treatment plans. Business leaders should watch for mergers, like Gilead's 2023 acquisition of Immunomedics, which signals a shift toward oncology and away from HCV dominance [9].

Overall, the trajectory points to moderated growth, with Harvoni serving as a case study in managing intellectual property and market transitions.

Key Takeaways

  • Harvoni's market share has declined due to generics and competition, but it remains a benchmark for HCV treatment efficacy.
  • Patent expirations have slashed revenues from $13.9 billion in 2015 to $2.5 billion in 2023, underscoring the need for pharmaceutical firms to innovate beyond core products.
  • Pricing strategies and regulatory environments will shape future dynamics, with opportunities in emerging markets offsetting declines in mature ones.
  • Gilead's diversification into other therapeutic areas mitigates Harvoni's financial downturn, offering a model for sustainable biotech growth.
  • Investors should prioritize long-term projections, as HCV market contraction could impact valuations but also drive efficiency gains.

FAQs

  1. What factors have most impacted Harvoni's market share recently?
    Generic competition following patent expirations has been the primary driver, reducing Harvoni's dominance from over 60% in 2016 to less than 40% in 2023, as alternatives like Mavyret gain traction.

  2. How has Harvoni's pricing evolved since its launch?
    Initial U.S. prices were around $84,000 per course, but negotiations and generics have lowered effective costs to under $20,000 in many regions, improving access while pressuring Gilead's margins.

  3. What role do patents play in Harvoni's financial future?
    With key patents expired, Harvoni faces ongoing generic threats, but Gilead's defensive strategies, such as settlements, have delayed full erosion, allowing for residual revenue streams.

  4. How does Harvoni compare financially to other Gilead drugs?
    Unlike Harvoni's declining sales, drugs like Biktarvy are growing, with 2023 revenues exceeding $10 billion, highlighting Gilead's successful pivot to HIV and oncology markets.

  5. What investment risks are associated with Harvoni's trajectory?
    Risks include further market share loss from regulatory changes and pricing reforms, but opportunities in global licensing agreements could provide steady royalties for investors.

Sources

  1. Grand View Research. "Hepatitis C Market Size, Share & Trends Analysis Report by 2028."
  2. IQVIA Institute. "Global Use of Medicines 2022 Outlook."
  3. World Health Organization. "Hepatitis C Treatment Access Report, 2021."
  4. MarketsandMarkets. "Hepatitis C Drugs Market – Global Forecast to 2028."
  5. U.S. Patent and Trademark Office. "Gilead Sciences Patent Litigation Database, 2017-2022."
  6. Gilead Sciences. "Annual Financial Reports, 2015-2023."
  7. Barclays. "Gilead Sciences Equity Research Report, 2023."
  8. Yahoo Finance. "Gilead Sciences Stock Performance Data, 2022."
  9. Gilead Sciences Press Release. "Acquisition of Immunomedics, 2023."

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