EPCLUSA Drug Patent Profile

When do Epclusa patents expire, and when can generic versions of Epclusa launch?

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

This drug has five hundred and twenty-one patent family members in forty-nine countries.

The generic ingredient in EPCLUSA is sofosbuvir; velpatasvir. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sofosbuvir; velpatasvir profile page.

DrugPatentWatch^® Generic Entry Outlook for Epclusa

Epclusa was eligible for patent challenges on June 28, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 30, 2034. 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

Summary for EPCLUSA

International Patents:	521
US Patents:	16
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	40
Drug Prices:	Drug price information for EPCLUSA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPCLUSA
What excipients (inactive ingredients) are in EPCLUSA?	EPCLUSA excipients list
DailyMed Link:	EPCLUSA at DailyMed

See drug prices for EPCLUSA

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

Constraining patent/regulatory exclusivity:

9,757,406*PED

NDA:

208341

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

11,116,783*PED

NDA:

214187

Dosage:

PELLETS;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 EPCLUSA

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

Sponsor	Phase
Peking University People's Hospital	Phase 4
Cairns Hinterland Health Hospital and Health Services	Phase 4
Macfarlane Burnet Institute for Medical Research and Public Health Ltd	Phase 4

See all EPCLUSA clinical trials

Pharmacology for EPCLUSA

Drug Class	Hepatitis C Virus NS5A Inhibitor Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Organic Anion Transporting Polypeptide 2B1 Inhibitors P-Glycoprotein Inhibitors RNA Replicase Inhibitors

US Patents and Regulatory Information for EPCLUSA

EPCLUSA is protected by sixteen US patents and five FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,757,406.

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	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No	8,889,159*PED				Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	PELLETS;ORAL	214187-002	Jun 10, 2021		RX	Yes	Yes

EU/EMA Drug Approvals for EPCLUSA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Epclusa	sofosbuvir, velpatasvir	EMEA/H/C/004210 Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age and older (see sections 4.2, 4.4 and 5.1).	Authorised	no	no	no	2016-07-06

International Patents for EPCLUSA

When does loss-of-exclusivity occur for EPCLUSA?

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

Argentina

Australia

Canada

China

Eurasian Patent Organization

European Patent Office

Hong Kong

Japan

Mexico

New Zealand

Poland

Portugal

Singapore

Slovenia

South Korea

Spain

Taiwan

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 EPCLUSA around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	095133	FORMULACIÓN DE COMBINACIÓN DE DOS COMPUESTOS ANTIVIRALES
Singapore	10201700947U	CONDENSED IMIDAZOLYLIMIDAZOLES AS ANTIVIRAL COMPOUNDS
Canada	2763151	ESTER DE N-[(2 ' R) -2' -DESOXY-2' -FLUORO-2' -METHYL-P-PHENYL-5' -URIDYLYL]-L-ALANINE 1-METHYLETHYLE ET SON PROCEDE DE PRODUCTION (N- [(2'R) -2'-DEOXY-2'-FLUORO-2' -METHYL-P-PHENYL-5' -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION)

Supplementary Protection Certificates for EPCLUSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	67/2014	Austria		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462	2014/065	Ireland		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
2203462	C20140035	Estonia		PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014

Market Dynamics and Financial Trajectory for the Drug: Epclusa

Introduction

Epclusa, a medication developed by Gilead Sciences, is a significant player in the treatment of hepatitis C virus (HCV) infections. This article delves into the market dynamics and financial trajectory of Epclusa, highlighting key factors that influence its pricing, sales, and overall market impact.

Market Overview

Epclusa is a combination of sofosbuvir and velpatasvir, approved for the treatment of HCV genotypes 1-6. It has been a crucial addition to Gilead's portfolio, particularly in the liver disease segment.

Pricing Dynamics

The cost of Epclusa is a critical aspect of its market dynamics. Here are some key points:

High Cost in the U.S.

In the United States, the cost of Epclusa is notably high, with a full course of treatment estimated at around $74,000. This high pricing is largely due to:

• Patent Protection: Epclusa benefits from patent protection, allowing Gilead to maintain a monopoly and significant pricing power[4].
• R&D Costs: The high price also reflects the extensive research and development investments made by Gilead[4].

Global Pricing Variations

There is a significant variation in Epclusa's pricing across different countries. For instance:

• India: In India, generic versions of Epclusa are available at a fraction of the cost in the U.S., thanks to the country's pharmaceutical industry's ability to produce generics upon patent expiry or under license[4].
• Market Capacity to Pay: Pricing is often based on what the local market can bear, leading to substantial differences between countries like the U.S. and India[4].
• Healthcare Systems: The organization and structure of healthcare systems also impact drug prices, with single-payer systems often negotiating lower prices[4].

Financial Performance

Gilead's financial reports provide insights into the sales performance of Epclusa as part of their liver disease portfolio.

Recent Financial Results

• 2023 Financial Results: The liver disease portfolio, which includes Epclusa, saw sales remain flat at $691 million in the fourth quarter of 2023 compared to the same period in 2022. This was due to unfavorable pricing dynamics offset by higher demand across chronic HCV and HDV products[1].
• Full Year 2023: The liver disease portfolio sales decreased 1% to $2.8 billion in the full year 2023, primarily driven by unfavorable HCV pricing dynamics and foreign exchange rates, partially offset by higher demand across HCV, HDV, and HBV products[1].

Historical Context

• 2020 Financial Results: During 2020, the launch of Veklury overshadowed other product sales, including those of Epclusa. However, the continued impact of COVID-19 on HCV sales was notable, with HCV sales volume lower due to the pandemic[3].

Market Impact

Epclusa's market impact is significant, particularly in the treatment of HCV.

Patient Uptake and Demand

Despite the high cost, Epclusa has seen steady demand due to its efficacy in treating HCV. The medication's inclusion in various treatment guidelines and its broad genotype coverage contribute to its market presence.

Competitive Landscape

The HCV treatment market is competitive, with other drugs like Harvoni and Sovaldi also from Gilead. However, Epclusa's pan-genotypic coverage gives it a unique position in the market.

Regulatory and Patent Considerations

• Patent Expiry: The expiry of patents for HCV drugs can lead to the introduction of generic versions, which could impact Epclusa's sales. However, Gilead's patent protection in many regions ensures that Epclusa remains a branded product for the foreseeable future[4].

Global Access and Affordability

The high cost of Epclusa raises ethical questions about drug pricing and accessibility.

Government Negotiations

In some countries, governments engage in negotiations with pharmaceutical companies to make drugs more affordable. For example, the Indian government has been proactive in such negotiations, making Epclusa and other essential drugs more accessible to the population[4].

Generic Production

The production of generic versions of Epclusa in countries like India has significantly reduced the cost of treatment, making it more accessible to a broader population[4].

Conclusion

Epclusa's market dynamics are influenced by a combination of high R&D costs, patent protection, and varying global pricing strategies. While it remains a crucial treatment option for HCV, its high cost in regions like the U.S. contrasts sharply with more affordable generic alternatives available in other countries.

Key Takeaways

• High Pricing in the U.S.: Epclusa's cost in the U.S. is significantly high due to patent protection and R&D investments.
• Global Pricing Variations: Prices vary widely across countries, influenced by local market conditions and healthcare systems.
• Steady Demand: Despite high costs, Epclusa sees steady demand due to its efficacy and broad genotype coverage.
• Regulatory and Patent Considerations: Patent protection and regulatory environments play a crucial role in maintaining Epclusa's market position.
• Global Access and Affordability: Efforts to make Epclusa more affordable, such as government negotiations and generic production, are ongoing.

FAQs

1. Why is Epclusa so expensive in the U.S.?

   • Epclusa is expensive in the U.S. primarily due to patent protection and the recovery of extensive research and development investments[4].

2. How does the cost of Epclusa vary globally?

   • The cost of Epclusa varies significantly globally, with countries like India offering generic versions at a fraction of the U.S. cost due to differing patent laws and market dynamics[4].

3. What is the impact of COVID-19 on Epclusa sales?

   • The COVID-19 pandemic has had a mixed impact on Epclusa sales, with some periods seeing lower sales due to pandemic-related disruptions, but overall demand has remained relatively steady[1][3].

4. How does Epclusa compare to other HCV treatments?

   • Epclusa stands out due to its pan-genotypic coverage, making it a versatile treatment option compared to other HCV drugs like Harvoni and Sovaldi[4].

5. What efforts are being made to make Epclusa more affordable?

   • Efforts include government negotiations to lower prices and the production of generic versions in countries where patents have expired or are licensed differently[4].

Sources

1. Gilead Sciences Announces Fourth Quarter and Full Year 2023 Financial Results - Gilead Sciences
2. Gilead Sciences Announces Fourth Quarter and Full Year 2022 Financial Results - Gilead Sciences
3. Gilead Sciences Announces Fourth Quarter and Full Year 2020 Financial Results - Gilead Sciences
4. Epclusa Cost 2024 - HealthSouthwesternHills