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Last Updated: May 17, 2022

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 forty-one patent family members in forty-seven countries.

The generic ingredient in HARVONI is ledipasvir; sofosbuvir. There is one drug master file entry for this compound. One supplier is 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 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

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Drug patent expirations by year for HARVONI
Drug Prices for HARVONI

See drug prices for HARVONI

Drug Sales Revenue Trends for HARVONI

See drug sales revenues for HARVONI

DrugPatentWatch® Estimated Generic Entry Opportunity 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 eight FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of HARVONI is See Plans and Pricing.

This potential generic entry date is based on patent 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.

Patents protecting HARVONI

Combination formulation of two antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treating HCV
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

Antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antiviral compounds
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

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

Antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antiviral compounds
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

Methods for treating HCV
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing

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: See Plans and Pricing

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: See Plans and Pricing

INFORMATION ADDED TO THE DOSING SECTION IN REGARD TO THE TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDING PATIENTS WITH END STAGE RENAL DISEASE ON DIALYSIS
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

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

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: 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 HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-002 Aug 28, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir PELLETS;ORAL 212477-002 Aug 28, 2019 RX Yes Yes 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 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
Estimated Expiration: See Plans and Pricing

Patent: 9578
Estimated Expiration: See Plans and Pricing

Patent: 5131
Estimated Expiration: See Plans and Pricing

Australia

Patent: 12308295
Estimated Expiration: See Plans and Pricing

Patent: 12332827
Estimated Expiration: See Plans and Pricing

Patent: 12346217
Estimated Expiration: See Plans and Pricing

Patent: 14202687
Estimated Expiration: See Plans and Pricing

Patent: 15202842
Estimated Expiration: See Plans and Pricing

Patent: 16216641
Estimated Expiration: See Plans and Pricing

Patent: 18203696
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2014006324
Estimated Expiration: See Plans and Pricing

Patent: 2014010295
Estimated Expiration: See Plans and Pricing

Patent: 2014011938
Estimated Expiration: See Plans and Pricing

Patent: 2014012739
Estimated Expiration: See Plans and Pricing

Canada

Patent: 40242
Estimated Expiration: See Plans and Pricing

Patent: 52867
Estimated Expiration: See Plans and Pricing

Patent: 53495
Estimated Expiration: See Plans and Pricing

Patent: 56529
Estimated Expiration: See Plans and Pricing

Chile

Patent: 14000630
Estimated Expiration: See Plans and Pricing

Patent: 14001397
Estimated Expiration: See Plans and Pricing

Patent: 15002164
Estimated Expiration: See Plans and Pricing

China

Patent: 4039319
Estimated Expiration: See Plans and Pricing

Patent: 4144682
Estimated Expiration: See Plans and Pricing

Patent: 4244945
Estimated Expiration: See Plans and Pricing

Patent: 4244947
Estimated Expiration: See Plans and Pricing

Patent: 5748499
Estimated Expiration: See Plans and Pricing

Patent: 6166160
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 30366
Estimated Expiration: See Plans and Pricing

Patent: 70603
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 140177
Estimated Expiration: See Plans and Pricing

Patent: 140273
Estimated Expiration: See Plans and Pricing

Patent: 150453
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0180237
Estimated Expiration: See Plans and Pricing

Patent: 0200138
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 19896
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 09613
Estimated Expiration: See Plans and Pricing

Patent: 50786
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 14005678
Estimated Expiration: See Plans and Pricing

Patent: 14013312
Estimated Expiration: See Plans and Pricing

Patent: 15037311
Estimated Expiration: See Plans and Pricing

Patent: 21087299
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 6667
Estimated Expiration: See Plans and Pricing

Patent: 7296
Estimated Expiration: See Plans and Pricing

Patent: 9081
Estimated Expiration: See Plans and Pricing

Patent: 1490588
Estimated Expiration: See Plans and Pricing

Patent: 1490806
Estimated Expiration: See Plans and Pricing

Patent: 1490903
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 09613
Estimated Expiration: See Plans and Pricing

Patent: 76024
Estimated Expiration: See Plans and Pricing

Patent: 85340
Estimated Expiration: See Plans and Pricing

Patent: 50786
Estimated Expiration: See Plans and Pricing

Patent: 50013
Estimated Expiration: See Plans and Pricing

Patent: 77867
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2012013074
Estimated Expiration: See Plans and Pricing

Patent: 2012013382
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 02268
Estimated Expiration: See Plans and Pricing

Patent: 19869
Estimated Expiration: See Plans and Pricing

Patent: 31378
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 36588
Estimated Expiration: See Plans and Pricing

Patent: 47777
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1515
Estimated Expiration: See Plans and Pricing

Patent: 2889
Estimated Expiration: See Plans and Pricing

Patent: 3419
Estimated Expiration: See Plans and Pricing

Japan

Patent: 99327
Estimated Expiration: See Plans and Pricing

Patent: 73897
Estimated Expiration: See Plans and Pricing

Patent: 23002
Estimated Expiration: See Plans and Pricing

Patent: 20994
Estimated Expiration: See Plans and Pricing

Patent: 14526516
Estimated Expiration: See Plans and Pricing

Patent: 14532657
Estimated Expiration: See Plans and Pricing

Patent: 14533733
Estimated Expiration: See Plans and Pricing

Patent: 15508418
Estimated Expiration: See Plans and Pricing

Patent: 16053096
Estimated Expiration: See Plans and Pricing

Patent: 16155875
Estimated Expiration: See Plans and Pricing

Patent: 16166251
Estimated Expiration: See Plans and Pricing

Patent: 17057230
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 09613
Estimated Expiration: See Plans and Pricing

Patent: 50786
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 7735
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 6580
Estimated Expiration: See Plans and Pricing

Patent: 1816
Estimated Expiration: See Plans and Pricing

Patent: 4958
Estimated Expiration: See Plans and Pricing

Patent: 14003145
Estimated Expiration: See Plans and Pricing

Patent: 14005955
Estimated Expiration: See Plans and Pricing

Patent: 14006373
Estimated Expiration: See Plans and Pricing

Moldova, Republic of

Patent: 30
Estimated Expiration: See Plans and Pricing

Patent: 89
Estimated Expiration: See Plans and Pricing

Patent: 95
Estimated Expiration: See Plans and Pricing

Patent: 140035
Estimated Expiration: See Plans and Pricing

Patent: 140058
Estimated Expiration: See Plans and Pricing

Patent: 150080
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 009
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 906
Estimated Expiration: See Plans and Pricing

Patent: 150030
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3396
Estimated Expiration: See Plans and Pricing

Patent: 5087
Estimated Expiration: See Plans and Pricing

Patent: 5532
Estimated Expiration: See Plans and Pricing

Patent: 0391
Estimated Expiration: See Plans and Pricing

Patent: 9172
Estimated Expiration: See Plans and Pricing

Peru

Patent: 141056
Estimated Expiration: See Plans and Pricing

Patent: 141296
Estimated Expiration: See Plans and Pricing

Patent: 151778
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 014501133
Estimated Expiration: See Plans and Pricing

Patent: 015501710
Estimated Expiration: See Plans and Pricing

Poland

Patent: 09613
Estimated Expiration: See Plans and Pricing

Patent: 50786
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 09613
Estimated Expiration: See Plans and Pricing

Patent: 50786
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 975
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201602044W
Estimated Expiration: See Plans and Pricing

Patent: 201706949V
Estimated Expiration: See Plans and Pricing

Patent: 201400664W
Estimated Expiration: See Plans and Pricing

Patent: 201402609R
Estimated Expiration: See Plans and Pricing

Patent: 201506021X
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 09613
Estimated Expiration: See Plans and Pricing

Patent: 50786
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1404061
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1560994
Estimated Expiration: See Plans and Pricing

Patent: 1962522
Estimated Expiration: See Plans and Pricing

Patent: 1991298
Estimated Expiration: See Plans and Pricing

Patent: 140096029
Estimated Expiration: See Plans and Pricing

Patent: 140108645
Estimated Expiration: See Plans and Pricing

Patent: 140119012
Estimated Expiration: See Plans and Pricing

Patent: 160052797
Estimated Expiration: See Plans and Pricing

Patent: 190033643
Estimated Expiration: See Plans and Pricing

Patent: 190075142
Estimated Expiration: See Plans and Pricing

Patent: 200060782
Estimated Expiration: See Plans and Pricing

Spain

Patent: 59216
Estimated Expiration: See Plans and Pricing

Patent: 71458
Estimated Expiration: See Plans and Pricing

Patent: 17886
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 66773
Estimated Expiration: See Plans and Pricing

Patent: 26047
Estimated Expiration: See Plans and Pricing

Patent: 1318627
Estimated Expiration: See Plans and Pricing

Patent: 1325599
Estimated Expiration: See Plans and Pricing

Patent: 1444556
Estimated Expiration: See Plans and Pricing

Patent: 1840311
Estimated Expiration: See Plans and Pricing

Patent: 2042808
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1802537
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 4097
Estimated Expiration: See Plans and Pricing

Patent: 6087
Estimated Expiration: See Plans and Pricing

Patent: 8256
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 420
Estimated Expiration: See Plans and Pricing

Patent: 474
Estimated Expiration: See Plans and Pricing

Patent: 299
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 HARVONI around the world.

Country Patent Number Title Estimated Expiration
Cyprus 1119273 See Plans and Pricing
Spain 2548156 See Plans and Pricing
Singapore 11201400664W METHODS FOR TREATING HCV See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for HARVONI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2430014 132016000015690 Italy See Plans and Pricing PRODUCT NAME: LEDIPASVIR(HARVONI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/958, 20141118
2430014 2016004 Norway See Plans and Pricing PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958 20141203
2430014 2016/002 Ireland See Plans and Pricing PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141117
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
Boehringer Ingelheim
McKesson
Harvard Business School
Johnson and Johnson

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.