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VOSEVI Drug Patent Profile

When do Vosevi patents expire, and what generic alternatives are available?

Vosevi is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are eighteen patents protecting this drug.

This drug has six hundred and twenty-two patent family members in forty-nine countries.

The generic ingredient in VOSEVI is sofosbuvir; velpatasvir; voxilaprevir. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sofosbuvir; velpatasvir; voxilaprevir profile page.

DrugPatentWatch^® Generic Entry Outlook for Vosevi

Vosevi 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 December 1, 2037. 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 VOSEVI

International Patents:	622
US Patents:	18
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Drug Prices:	Drug price information for VOSEVI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VOSEVI
What excipients (inactive ingredients) are in VOSEVI?	VOSEVI excipients list
DailyMed Link:	VOSEVI at DailyMed

See drug prices for VOSEVI

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

Constraining patent/regulatory exclusivity:

11,338,007*PED

NDA:

209195

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 VOSEVI

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

Sponsor	Phase
Peking University People's Hospital	Phase 4
Partners in Health	Phase 4
Gilead Sciences	Phase 3

See all VOSEVI clinical trials

Pharmacology for VOSEVI

Drug Class	Hepatitis C Virus NS3/4A Protease Inhibitor Hepatitis C Virus NS5A Inhibitor Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors HCV NS3/4A Protease 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 VOSEVI

VOSEVI is protected by nineteen US patents.

This potential generic entry date is based on patent 11,338,007.

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	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	8,957,046
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	11,338,007*PED				Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	7,964,580*PED				Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	10,912,814		Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	8,735,372*PED				Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	8,575,135*PED				Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	11,116,783*PED				Y

International Patents for VOSEVI

When does loss-of-exclusivity occur for VOSEVI?

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

Argentina

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

Morocco

Singapore

South Korea

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 VOSEVI around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	263155	פורמולציה משולבת של שלוש תרכובות אנטי-ויראליות (Combination formulation of three antiviral compounds)
Japan	2013523767
Japan	6106716
Slovenia	2552930
Denmark	2203462
Taiwan	201318627	Methods and compositions for treating hepatitis C virus
South Korea	101890400

Supplementary Protection Certificates for VOSEVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	92600	Luxembourg		PRODUCT NAME: SOVALDI (SOFOSBUVIR); AUTHORISATION NUMBER AND DATE: EU/1/13/894(001-002) - SOVALDI - SOFOSBUVIR 20140117
2203462	C201430078	Spain		PRODUCT NAME: SOFOSBUVIR; NATIONAL AUTHORISATION NUMBER: EU/1/13/894; DATE OF AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/894; DATE OF FIRST AUTHORISATION IN EEA: 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	PA2014040,C2203462	Lithuania		PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462	SPC/GB14/078	United Kingdom		PRODUCT NAME: SOFOSBUVIR; REGISTERED: UK EU/1/13/894/001 20140117; UK EU/1/13/894/002 20140117
2203462	PA2014040	Lithuania		PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462	2014/065	Ireland		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116

VOSEVI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VOSEVI

Introduction

VOSEVI, a direct-acting antiviral (DAA) developed by Gilead Sciences, is a significant player in the treatment of chronic Hepatitis C virus (HCV) infection. This article delves into the market dynamics and financial trajectory of VOSEVI, highlighting key factors driving its market presence and the broader implications for the HCV treatment landscape.

Market Size and Growth

The global HCV market, which includes drugs like VOSEVI, is projected to experience substantial growth. By 2034, the HCV market is estimated to reach USD 47.1 billion, growing at a Compound Annual Growth Rate (CAGR) of 9.14% from 2024 to 2034[4].

Key Drivers of the HCV Market

Rise in Liver Diseases and Infectious Diseases

The increasing incidence of liver diseases and infectious diseases globally is a significant driver for the HCV market. Factors such as the rise in hospital-acquired infections, the surge in prevalence of infectious diseases, and the growing demand for early diagnosis of chronic infectious diseases contribute to the market's growth[1].

Advancements in Direct-Acting Antivirals (DAAs)

VOSEVI, as a DAA, benefits from advancements in this therapeutic class. DAAs have revolutionized HCV treatment by offering higher cure rates, shorter treatment durations, and fewer side effects compared to traditional therapies. The approval of VOSEVI by the US FDA for the re-treatment of chronic HCV infection in adult patients further solidifies its market position[4].

Personalized Medicine

The increasing adoption of personalized medicine is another key driver. Tailoring treatments to individual genetic profiles and disease characteristics enhances the efficacy of DAAs like VOSEVI, reducing adverse effects and optimizing patient outcomes[4].

Government Initiatives and Regulatory Approvals

Government initiatives to spread awareness about HCV treatment and fast-track regulatory approvals for novel drugs provide lucrative opportunities for the expansion of the HCV DAA market. The approval of VOSEVI based on findings from the Phase 3 POLARIS-1 and POLARIS-4 studies is a testament to this[4].

Financial Performance of Gilead Sciences

Revenue Impact

Gilead Sciences, the manufacturer of VOSEVI, has seen varying revenue trends in recent years. While total product sales have been influenced by the COVID-19 pandemic and the performance of other drugs like Veklury (remdesivir), the company's overall revenue has remained robust.

• In 2020, Gilead's total product sales increased by 10% to $24.4 billion, largely due to the launch of Veklury. However, HCV sales volume decreased due to the pandemic's impact[3].
• In 2022, total revenue was flat compared to 2021, with increased sales in Oncology and HIV offset by lower Veklury sales. This stability indicates a diversified revenue stream that can support the market presence of VOSEVI[5].

Product Sales Excluding Veklury

While Veklury sales have been a significant factor in Gilead's revenue, the sales of other products, including VOSEVI, have shown resilience. For instance, in the fourth quarter of 2020, other product sales, which include VOSEVI, increased by 7% to $498 million, primarily due to higher sales volume of Vemlidy and other international locations[3].

Market Trends and New Product Launches

Launch of VOSEVI

The launch of VOSEVI in various markets has been a key trend. For example, in 2020, Gilead announced the launch of VOSEVI in China, marking a significant expansion of its HCV treatment portfolio[1].

Competitive Landscape

The HCV market is competitive, with other major players like AbbVie launching products such as Mavyret, which is approved for the treatment of all genotypes of HCV in pediatric patients. This competition drives innovation and pricing strategies, but VOSEVI's unique positioning and FDA approvals maintain its market relevance[1].

Challenges and Opportunities

Adverse Effects and Regulatory Hurdles

Despite its benefits, VOSEVI faces challenges related to severe adverse effects associated with antiviral drugs. However, government initiatives and fast-track regulatory approvals offer opportunities for growth and market expansion[1].

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the HCV market. While it led to lower HCV sales volume in 2020 due to healthcare resource diversion, it also highlighted the importance of effective antiviral treatments, potentially boosting long-term demand for DAAs like VOSEVI[3].

Key Takeaways

• Market Growth: The HCV market is expected to grow significantly, driven by advancements in DAAs and personalized medicine.
• Regulatory Approvals: VOSEVI's FDA approval and launches in various markets solidify its market position.
• Financial Performance: Gilead Sciences' diversified revenue stream supports the market presence of VOSEVI despite fluctuations in other product sales.
• Challenges and Opportunities: While adverse effects and regulatory hurdles exist, government initiatives and the pandemic's long-term impact offer growth opportunities.

FAQs

Q: What is VOSEVI used for? A: VOSEVI is a direct-acting antiviral (DAA) used for the re-treatment of chronic HCV infection in adult patients with genotype 1, 2, 3, 4, 5, or 6 who have been treated with an NS5A inhibitor-containing therapy or with genotype 1a or 3 earlier treated with a sofosbuvir-containing therapy without an NS5A inhibitor[4].

Q: How does VOSEVI fit into the broader HCV market? A: VOSEVI is part of the growing HCV market, which is expected to reach USD 47.1 billion by 2034. It benefits from advancements in DAAs and the increasing adoption of personalized medicine[4].

Q: What are the key drivers of the HCV market? A: Key drivers include the rise in liver diseases, the surge in prevalence of infectious diseases, the growing demand for early diagnosis, and advancements in DAAs[1].

Q: How has the COVID-19 pandemic affected VOSEVI sales? A: The pandemic led to lower HCV sales volume in 2020 but highlighted the importance of effective antiviral treatments, potentially boosting long-term demand for DAAs like VOSEVI[3].

Q: What are the challenges faced by VOSEVI in the market? A: VOSEVI faces challenges related to severe adverse effects associated with antiviral drugs, but government initiatives and fast-track regulatory approvals offer opportunities for growth[1].

Sources

1. Allied Market Research: HCV Direct Acting Antiviral Market Size, Trend And Industry Report.
2. Gilead Sciences: Gilead Sciences Announces Fourth Quarter and Full Year 2023 Financial Results.
3. Gilead Sciences: Gilead Sciences Announces Fourth Quarter and Full Year 2020 Financial Results.
4. BioSpace: Hepatitis C Market Estimated to Reach USD 47.1 Billion by 2034.
5. Gilead Sciences: Gilead Sciences Announces Fourth Quarter and Full Year 2022 Financial Results.