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HARVONI Drug Patent Profile

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

Summary for HARVONI

International Patents:	555
US Patents:	17
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	36
Patent Applications:	34
Drug Prices:	Drug price information for HARVONI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HARVONI
What excipients (inactive ingredients) are in HARVONI?	HARVONI excipients list
DailyMed Link:	HARVONI at DailyMed

See drug prices for HARVONI

See drug sales revenues for HARVONI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for HARVONI

Constraining patent/regulatory exclusivity:

10,456,414

NDA:

212477

Dosage:

PELLETS;ORAL

Constraining patent/regulatory exclusivity:

10,039,779*PED

NDA:

205834

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

Sponsor	Phase
Mansoura University	Phase 3
Cairo University	Phase 2/Phase 3
University of Maryland, College Park	Early Phase 1

See all HARVONI clinical trials

Pharmacology for HARVONI

Drug Class	Hepatitis C Virus NS5A Inhibitor Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors P-Glycoprotein Inhibitors RNA Replicase Inhibitors

US Patents and Regulatory Information for HARVONI

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

This potential generic entry date is based on patent 10,456,414.

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	9,393,256*PED				Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-002	Aug 28, 2019		RX	Yes	No	8,334,270*PED				Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-002	Aug 28, 2019		RX	Yes	Yes	9,393,256*PED				Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-002	Aug 28, 2019		RX	Yes	No	8,735,372*PED				Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-001	Oct 10, 2014		RX	Yes	Yes	7,964,580*PED				Y

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

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Germany

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Moldova, Republic of

Montenegro

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Turkey

Ukraine

Uruguay

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
Mexico	2011012058	COMPUESTOS ANTIVIRALES. (ANTIVIRAL COMPOUNDS.)
Slovenia	2826784
Brazil	PI0809654	Composto, seu estereoisômero, sal, hidrato, solvato, ou forma cristalina do mesmo e processo para preparar o mesmo e uso do mesmo, composição para tratamento e/ou profilaxia de quaisquer agentes virais, uso de composto, método de tratar indivíduo
Hungary	S1600001
South Korea	20120034662	N-[(2'R)-2'-DEOXY-2'-FLUORO-2'-METHYL-P-PHENYL-5'-URIDYLYL]-L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION

Supplementary Protection Certificates for HARVONI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2430014	16C0005	France		PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958/001-002 20141118
2430014	300796	Netherlands		PRODUCT NAME: LEDIPASVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/14/958 20141118
2203462	PA2014040	Lithuania		PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462	122014000108	Germany		PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2203462	300704	Netherlands		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117

HARVONI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Harvoni

Introduction

Harvoni, a combination therapy of ledipasvir and sofosbuvir, has been a cornerstone in the treatment of hepatitis C virus (HCV) infection since its approval. Developed by Gilead Sciences, Inc., Harvoni has experienced significant market and financial fluctuations. Here, we delve into the market dynamics and financial trajectory of this pivotal drug.

Market Dominance and Competition

Harvoni was launched in 2014 and quickly became the leading treatment for HCV, particularly for genotype 1 patients. It dominated the market with its high efficacy and convenience of a single tablet regimen[4].

However, the market landscape has evolved with the introduction of competing drugs. AbbVie's Mavyret, launched in 2017, posed a significant challenge to Harvoni's market share. Mavyret was priced lower, at $13,200 per month for an 8-week treatment course, compared to Harvoni's $31,500 per month for a 12-week course. This aggressive pricing strategy by AbbVie led to Mavyret capturing 32% of the market, significantly impacting Harvoni's sales[3].

Pricing and Cost

The high cost of Harvoni has been a major factor influencing its market dynamics. The list price for a 12-week treatment course is approximately $94,500, or around $1,100 per pill. Despite this, the average revenue per treatment reported by Gilead was lower, around $54,000 in 2015, due to significant discounts negotiated with insurers[4].

The pricing pressure intensified with the launch of other direct-acting antivirals (DAAs) like Merck’s Zepatier, which was priced at $54,000 per treatment. This led to a 22% drop in the price per treatment for Harvoni in the first half of 2016[4].

Regulatory and Insurance Challenges

Stringent regulatory norms and insurance reimbursement issues have also impacted Harvoni's market performance. Different regulatory bodies in various countries have delayed the approval and commercialization of new HCV treatments, affecting the availability of products in the market. In the United States, insurance providers often deny coverage or reimburse only a small portion of the treatment cost, further reducing the market size[1].

Financial Performance

The financial trajectory of Harvoni has been marked by significant highs and subsequent declines. At its peak in 2015, Harvoni, along with Sovaldi, generated $19.1 billion in sales for Gilead Sciences. However, by 2017, the sales had dropped to $9.1 billion, and the guidance for 2018 was set at a much lower $3.5 billion to $4 billion due to increased competition and pricing pressures[3].

Gilead's overall revenue from HCV treatments, including Harvoni, has continued to decline. The company's reliance on Harvoni and other HCV drugs has been reduced as they diversify into other therapeutic areas such as HIV and oncology. For instance, in 2023, Gilead's total revenue was $27.1 billion, with a significant portion coming from HIV and oncology sales rather than HCV treatments[2].

Global Market Share

North America, particularly the United States, has been the largest market for Harvoni, accounting for over 45% of the global HCV treatment market share in 2015. However, the Asia Pacific region is expected to exhibit the highest compound annual growth rate (CAGR) due to a large patient pool in countries like India and China[1].

Impact of New Treatments and Market Dynamics

The success of DAAs like Harvoni has transformed HCV into a curable disease, but this success also brings challenges. The high treatment rates and low incidence rates of new HCV cases have led to a declining patient population seeking treatment. This trend, combined with intense competition and limited price erosion due to patent protection, suggests that the revenue stream from HCV treatments may stabilize but not grow significantly in the coming years[4].

Key Players and Market Consolidation

The global HCV treatment market is consolidated, with a few key players dominating the landscape. Gilead Sciences, Inc. has been the market leader, contributing around 80.1% of the market share, primarily through the sales of Harvoni and Sovaldi. Other significant players include Bristol-Myers Squibb Company, AbbVie Inc., and Merck & Co., Inc.[1].

Future Outlook

The future outlook for Harvoni is marked by stabilization rather than growth. The competitive landscape is expected to remain intense, with new pan-genotypic drugs entering the market. However, these new drugs are likely to be priced at a premium relative to existing DAAs, maintaining price stability. The decline in diagnosed prevalent cases of chronic HCV and the high treatment rates in many countries will continue to impact the sustainability of future HCV drug revenues[4].

Key Takeaways

• Market Dominance: Harvoni dominated the HCV treatment market upon its launch but faced significant competition from AbbVie's Mavyret.
• Pricing Challenges: High list prices and subsequent discounts have affected revenue per treatment.
• Regulatory and Insurance Issues: Stringent regulations and insurance reimbursement challenges have hindered market growth.
• Financial Performance: Sales peaked in 2015 but declined significantly due to competition and pricing pressures.
• Global Market Share: North America remains the largest market, but the Asia Pacific region shows high growth potential.
• Market Dynamics: The curable nature of HCV and declining patient population impact long-term revenue streams.

FAQs

Q: What is the list price of Harvoni for a 12-week treatment course? A: The list price of Harvoni for a 12-week treatment course is approximately $94,500[1].

Q: How has competition affected Harvoni's market share? A: The introduction of AbbVie's Mavyret at a lower price point has significantly eroded Harvoni's market share, with Mavyret capturing 32% of the market[3].

Q: What are the main challenges facing the HCV treatment market? A: High drug costs, stringent regulatory norms, and insurance reimbursement issues are major challenges[1].

Q: How has Gilead's revenue from HCV treatments changed over the years? A: Gilead's revenue from HCV treatments peaked in 2015 at $19.1 billion but declined to $9.1 billion in 2017 and further to $3.5 billion to $4 billion in 2018[3].

Q: What is the outlook for the future of HCV treatment revenues? A: The revenue stream is expected to stabilize but not grow significantly due to a declining patient population and intense competition[4].

Sources

1. Persistence Market Research - Global Hepatitis C Treatment Market[1]
2. Gilead Sciences - Fourth Quarter and Full Year 2023 Financial Results[2]
3. FiercePharma - Gilead's hep C guidance comes far short of expectations as AbbVie's Mavyret scoops up share[3]
4. Drug Development & Delivery - Recent Success in HCV Treatment Brings Relief to Patients but Challenges to Companies[4]