Sofosbuvir; velpatasvir; voxilaprevir - Generic Drug Details

What are the generic sources for sofosbuvir; velpatasvir; voxilaprevir and what is the scope of freedom to operate?

Sofosbuvir; velpatasvir; voxilaprevir is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sofosbuvir; velpatasvir; voxilaprevir has six hundred and twenty-two patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for sofosbuvir; velpatasvir; voxilaprevir

International Patents:	622
US Patents:	18
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	18
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sofosbuvir; velpatasvir; voxilaprevir
DailyMed Link:	sofosbuvir; velpatasvir; voxilaprevir at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for sofosbuvir; velpatasvir; voxilaprevir

Constraining patent/regulatory exclusivity:

11,338,007*PED

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 sofosbuvir; velpatasvir; voxilaprevir

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

Sponsor	Phase
Peking University People's Hospital	Phase 4
Helwan University	Phase 4
Kirby Institute	Phase 4

See all sofosbuvir; velpatasvir; voxilaprevir clinical trials

Pharmacology for sofosbuvir; velpatasvir; voxilaprevir

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

Anatomical Therapeutic Chemical (ATC) Classes for sofosbuvir; velpatasvir; voxilaprevir

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for sofosbuvir; velpatasvir; voxilaprevir

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	8,940,718*PED				Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	9,085,573*PED				Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	10,912,814		Y

International Patents for sofosbuvir; velpatasvir; voxilaprevir

Country	Patent Number	Title	Estimated Expiration
Slovenia	2640719
Mexico	350725	FOSFORAMIDATOS DE NUCLEOSIDO. (NUCLEOSIDE PHOSPHORAMIDATES.)
Serbia	56975	METODE ZA LEČENJE HCV-A (METHODS FOR TREATING HCV)

Supplementary Protection Certificates for sofosbuvir; velpatasvir; voxilaprevir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	2014029	Norway		PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117
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	CA 2014 00061	Denmark		PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116

Sofosbuvir; velpatasvir; voxilaprevir Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Vosevi (Sofosbuvir, Velpatasvir, Voxilaprevir)

Introduction

Vosevi, a combination of sofosbuvir, velpatasvir, and voxilaprevir, is a groundbreaking antiviral medication approved for the treatment of chronic hepatitis C virus (HCV) infection. This article delves into the market dynamics and financial trajectory of Vosevi, highlighting its efficacy, cost factors, and the impact on the healthcare market.

Efficacy and Clinical Significance

Vosevi has demonstrated exceptional efficacy in treating HCV across all six genotypes, including in patients with liver cirrhosis and those who have failed previous treatments with direct-acting antivirals (DAAs)[1][4].

• In clinical trials, Vosevi achieved a sustained virologic response (SVR12) rate of over 95%, with 96% of patients achieving undetectable viral loads 12 weeks after completing therapy[1][4].

Market Approval and Regulation

Vosevi received marketing authorization from the European Medicines Agency (EMA) in July 2017 and was approved by the U.S. Food and Drug Administration (FDA) for use in adults with chronic HCV infection, particularly as salvage therapy for those who have failed other DAA regimens[1][4].

Cost and Pricing

The cost of Vosevi is a significant factor in its market dynamics. Here are some key points:

Brand-Name Costs

• Vosevi, as a brand-name drug, is expensive due to the extensive research and development costs incurred by its manufacturer, Gilead Sciences. The cost can vary based on factors such as the quantity prescribed, insurance coverage, and pharmacy used[2].

Comparison with Other Treatments

• The cost of Vosevi is comparable to other HCV treatments like Epclusa (velpatasvir/sofosbuvir). The pricing depends on the treatment plan, insurance coverage, and availability of savings programs[2].

Generic Competition

• While Vosevi is still under patent, the eventual introduction of generic versions could significantly reduce costs. Generic drugs contain the same active ingredients as brand-name drugs but do not require the same costly testing and development processes[2].

Financial Assistance and Savings Programs

To make Vosevi more accessible, several financial assistance programs are available:

Co-pay Coupon Programs

• Gilead Support Path® offers co-pay coupon programs that can reduce out-of-pocket costs for commercially insured patients. These programs can provide up to $10,000 in cost-sharing assistance per calendar year[5].

Insurance Considerations

• The cost with insurance varies based on the specific plan benefits, prior authorization requirements, and the pharmacy used. Patients may also benefit from getting a 3-month supply of Vosevi, which can reduce the number of pharmacy visits and potentially lower costs[2].

Market Impact and Utilization

The introduction of Vosevi and other DAAs has significantly transformed the HCV treatment landscape:

Transformation of HCV Treatment

• DAAs, including Vosevi, have replaced traditional interferon-based therapies, offering higher cure rates and better tolerability. This shift has improved patient outcomes and reduced the burden on healthcare systems[3].

Budgetary Impact

• Despite the high initial costs, the long-term benefits of DAAs like Vosevi include reduced healthcare spending on complications such as cirrhosis, liver failure, and hepatocellular carcinoma. However, the initial demand for these expensive treatments has raised concerns about budgetary impact on healthcare systems[3].

Safety and Adverse Events

While Vosevi is generally well-tolerated, it comes with some important safety considerations:

Common Adverse Events

• The most common adverse events associated with Vosevi include headache, fatigue, diarrhea, and nausea. However, the proportion of patients who permanently discontinued treatment due to adverse events is low, at 0.2%[4].

Boxed Warning

• Vosevi carries a boxed warning regarding the risk of hepatitis B virus (HBV) reactivation in HCV/HBV coinfected patients[4].

Patient Population and Unmet Needs

Vosevi addresses a significant unmet need in the treatment of HCV:

Retreatment of Failed Patients

• Vosevi is specifically approved for patients who have failed previous treatments with DAAs, providing a crucial option for those who were otherwise at risk of progressing to advanced liver disease[4].

Global Impact

• Since its introduction, sofosbuvir-based regimens, including Vosevi, have treated over 1.4 million patients worldwide, significantly expanding access to effective HCV treatment[4].

Future Studies and Monitoring

To ensure the long-term safety and efficacy of Vosevi, ongoing studies are being conducted:

Risk of Liver Cancer Recurrence

• A study is underway to evaluate the risk of liver cancer recurrence in patients who have previously had liver cancer and are treated with Vosevi and other DAAs[1].

Key Takeaways

• Efficacy: Vosevi is highly effective in treating chronic HCV infection across all genotypes.
• Cost: While expensive, financial assistance programs and potential future generic competition can reduce costs.
• Market Impact: Vosevi has transformed HCV treatment, offering better outcomes and reduced long-term healthcare costs.
• Safety: Generally well-tolerated but with important safety considerations, including the risk of HBV reactivation.
• Patient Population: Addresses unmet needs for patients who have failed previous DAA treatments.

FAQs

Q: What is Vosevi used for?

A: Vosevi is used to treat chronic hepatitis C virus (HCV) infection in adults, including those with liver cirrhosis and those who have failed previous treatments with direct-acting antivirals.

Q: How effective is Vosevi in treating HCV?

A: Vosevi has shown high efficacy, with over 95% of patients achieving a sustained virologic response (SVR12) in clinical trials.

Q: What are the common side effects of Vosevi?

A: The most common adverse events include headache, fatigue, diarrhea, and nausea.

Q: Is Vosevi expensive, and are there any financial assistance programs available?

A: Yes, Vosevi is expensive, but financial assistance programs like Gilead Support Path® can help reduce out-of-pocket costs.

Q: What is the boxed warning associated with Vosevi?

A: Vosevi carries a boxed warning regarding the risk of hepatitis B virus (HBV) reactivation in HCV/HBV coinfected patients.

Sources

1. European Medicines Agency. Vosevi | European Medicines Agency (EMA).
2. Medical News Today. Cost and Vosevi: How to find savings, lower costs, and more.
3. The American Journal of Managed Care. Cost Burden of Hepatitis C Virus Treatment in Commercially Insured Patients.
4. Gilead Sciences. U.S. Food and Drug Administration Approves Gilead's Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for Re-treatment of Adults with Chronic Hepatitis C Virus.
5. Gilead Support Path. Co-pay Coupon Program Enrollment.