Sofosbuvir; velpatasvir - Generic Drug Details

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

Sofosbuvir; velpatasvir is the generic ingredient in two branded drugs marketed by Gilead Sciences Inc and is included in three NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sofosbuvir; velpatasvir has five hundred and nineteen patent family members in forty-eight countries.

Two suppliers are listed for this compound.

Summary for sofosbuvir; velpatasvir

International Patents:	519
US Patents:	21
Tradenames:	2
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Clinical Trials:	74
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sofosbuvir; velpatasvir
DailyMed Link:	sofosbuvir; velpatasvir at DailyMed

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

Dosage:

TABLET;ORAL

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 sofosbuvir; velpatasvir

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

Sponsor	Phase
University of Bristol	Early Phase 1
Burnet Institute	Early Phase 1
UNITAID	Early Phase 1

See all sofosbuvir; velpatasvir clinical trials

Pharmacology for sofosbuvir; velpatasvir

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

Anatomical Therapeutic Chemical (ATC) Classes for sofosbuvir; velpatasvir

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

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

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	PELLETS;ORAL	214187-001	Jun 10, 2021		RX	Yes	No
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes					Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes					Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes					Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes					Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	PELLETS;ORAL	214187-001	Jun 10, 2021		RX	Yes	No					Y

EU/EMA Drug Approvals for sofosbuvir; velpatasvir

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 sofosbuvir; velpatasvir

Country	Patent Number	Title	Estimated Expiration
Singapore	10201708263S	N- [ (2 ' R) -2 ' -DEOXY-2 ' -FLUORO-2 ' -METHYL-P-PHENYL-5 ' -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION
South Korea	20180026563	항바이러스 화합물 (ANTIVIRAL COMPOUNDS)
Hong Kong	1213571	'- '- '- '- `-脱氧- `-氟- `-甲基- -苯基- `-尿苷酰基 -丙氨酸結晶形式 -甲基乙基酯 (N-[(2R)-2-DEOXY-2 -FLUORO-2-METHYL-P-PHENYL-5 -URIDYLYL]-L- ALANINE 1-METHYLETHYL ESTER IN CRYSTALLINE FORM N-[ (2R)-2--2--2--P--5-]-L- 1-)
Hong Kong	1202268	用於治療 的組合物和方法 (COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS HCV)
Hong Kong	1199645	含磷活性物質的立體選擇性合成 (STEREOSELECTIVE SYNTHESIS OF PHOSPHORUS CONTAINING ACTIVES)
Uruguay	34420	?MÉTODOS DE TRATAMIENTO DEL VIRUS DE LA HEPATITIS C CON QUE DE GS-7977 Y RIBAVIRINA, COMPOSICIONES Y USOS"

Supplementary Protection Certificates for sofosbuvir; velpatasvir

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
2203462	C20140035	Estonia		PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2203462	PA2014040,C2203462	Lithuania		PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462	132014902310732	Italy		PRODUCT NAME: SOFOSBUVIR(SOVALDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/894, 20140117

Sofosbuvir; velpatasvir Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Sofosbuvir and Velpatasvir

Introduction

The introduction of sofosbuvir and velpatasvir, key components of direct-acting antivirals (DAAs), has revolutionized the treatment of hepatitis C virus (HCV). This article delves into the market dynamics and financial trajectory of these drugs, highlighting their clinical and economic impact, market trends, and financial performance.

Clinical Impact of Sofosbuvir and Velpatasvir

Paradigm Shift in HCV Treatment

The approval of sofosbuvir/velpatasvir (SOF/VEL), marketed as Epclusa®, in 2017 marked a significant shift in HCV treatment. These DAAs have achieved high cure rates, significantly improving patient outcomes and contributing to the global effort to eliminate HCV[1].

High Sustained Viral Response Rates

SOF/VEL has demonstrated an average sustained viral response (SVR) rate of 98.9%, far surpassing the 61.0% rate of previous therapies. This high efficacy has transformed the treatment landscape, enabling healthcare providers to cure a vast majority of patients[1].

Reduction in Liver Complications

The use of SOF/VEL has led to a substantial reduction in liver complications, including decompensated cirrhosis, hepatocellular carcinomas, and liver transplants. Specifically, it has avoided 92% of decompensated cirrhosis, 80% of hepatocellular carcinomas, and 87% of liver transplants, along with an 85% reduction in liver-related mortality[1].

Economic Impact

Cost Savings

The economic evaluation of SOF/VEL in Spain revealed significant cost savings. By reducing the number of liver complications, SOF/VEL resulted in savings of €197 million associated with the management of these clinical events. This includes a decrease in the cost of managing decompensated cirrhosis, liver transplants, and hepatocellular carcinoma[1].

Healthcare System Benefits

The reduced clinical and economic burden of HCV has benefited healthcare systems globally. By minimizing the need for costly procedures like liver transplants and reducing hospitalizations, SOF/VEL has contributed to the overall efficiency and cost-effectiveness of HCV treatment[1].

Market Trends

Global Adoption

Since their introduction, sofosbuvir-based regimens have been widely adopted globally. Over 1.4 million patients worldwide have been treated with these regimens, reflecting their acceptance and efficacy in diverse patient populations[2].

Generic and Biosimilar Impact

The availability of generic versions of DAAs, such as generic daclatasvir, has expanded access to HCV treatment. By the end of 2020, generic daclatasvir sales had reached a milestone of 3 million packs, indicating a growing market driven by affordability and accessibility[4].

Pricing Strategies

Countries are leveraging volume-based pricing and centralized procurement to reduce the cost of DAAs. This approach allows for lower costs through bulk purchasing, making these treatments more affordable and accessible to a broader population[4].

Financial Performance

Revenue Impact

Gilead Sciences, the manufacturer of SOF/VEL and other sofosbuvir-based treatments, has seen significant revenue from these products. However, the financial performance has been influenced by various factors, including the COVID-19 pandemic and changes in market dynamics.

COVID-19 Pandemic Effects

The COVID-19 pandemic has had a mixed impact on Gilead's HCV franchise. While the launch of Veklury (remdesivir) for COVID-19 treatment boosted overall revenues, it also led to a decline in HCV sales volume due to pandemic-related disruptions[3].

Sales Trends

In 2020, Gilead's product sales excluding Veklury decreased by 7% and 3% for the fourth quarter and full year, respectively, compared to 2019. This decline was partly due to lower HCV sales volume and the loss of exclusivity for certain HIV products[3].

Patient Access and Affordability

Financial Assistance Programs

To enhance patient access, Gilead offers financial assistance programs through its Support Path® initiative. This program provides co-pay coupons for eligible commercially insured patients, helping to reduce out-of-pocket costs for treatments like Epclusa® and Vosevi®[5].

Global Access Initiatives

WHO guideline revisions and global health initiatives aim to make DAAs more accessible to adolescents and children. Efforts to optimize supply chains and procurement processes are expected to further reduce treatment costs, making these life-saving therapies more affordable worldwide[4].

Competitive Landscape

Portfolio of Sofosbuvir-Based Treatments

Gilead's portfolio includes multiple sofosbuvir-based treatments, such as Epclusa®, Harvoni®, Sovaldi®, and Vosevi®. Each of these treatments addresses different patient needs, including re-treatment options for those who have failed previous therapies[2].

Market Competition

The HCV market is competitive, with various DAAs available. However, sofosbuvir-based regimens remain a cornerstone of treatment due to their high efficacy and convenience, such as the once-daily single-tablet regimen offered by Vosevi®[2].

Future Outlook

Continued Innovation

The future of HCV treatment is likely to be shaped by continued innovation in DAAs. New treatments and formulations will aim to address remaining unmet needs, such as shorter treatment durations and further reduced side effects.

Global Health Initiatives

Global health initiatives will play a crucial role in making HCV treatment more accessible. Efforts to sustain and expand access to diagnostics and treatment will be essential in the pursuit of HCV elimination.

Key Takeaways

• High Efficacy: Sofosbuvir and velpatasvir have achieved high SVR rates, transforming HCV treatment.
• Economic Benefits: Significant cost savings have been realized through reduced liver complications and healthcare system efficiencies.
• Market Trends: Global adoption, generic and biosimilar availability, and pricing strategies are shaping the market.
• Financial Performance: Revenue impact has been influenced by COVID-19 and changes in market dynamics.
• Patient Access: Financial assistance programs and global access initiatives are enhancing affordability.

FAQs

What is the clinical efficacy of sofosbuvir and velpatasvir in treating HCV?

Sofosbuvir and velpatasvir have demonstrated an average SVR rate of 98.9%, significantly higher than previous therapies[1].

How have sofosbuvir-based treatments impacted the economic burden of HCV?

These treatments have resulted in significant cost savings by reducing liver complications and associated healthcare costs, amounting to savings of €197 million in Spain[1].

What are the key factors influencing the financial performance of Gilead's HCV franchise?

The COVID-19 pandemic, changes in market dynamics, and the loss of exclusivity for certain products have impacted revenue trends[3].

How are financial assistance programs helping patients access sofosbuvir-based treatments?

Gilead's Support Path® program provides co-pay coupons to reduce out-of-pocket costs for eligible patients, enhancing access to treatments like Epclusa® and Vosevi®[5].

What are the future prospects for HCV treatment and elimination?

Continued innovation in DAAs, global health initiatives, and efforts to make diagnostics and treatment more accessible will be crucial in the pursuit of HCV elimination.

Sources

1. Evaluation of the clinical and economic value of sofosbuvir/velpatasvir in patients with chronic hepatitis C in Spain. Elsevier.
2. U.S. Food and Drug Administration Approves Gilead's Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir) for Re-Treatment of Adults with Chronic Hepatitis C Virus. Gilead.
3. Gilead Sciences Announces Fourth Quarter and Full Year 2020 Financial Results. Gilead.
4. HCV Market Intelligence Report 2021 and Preliminary HBV Market Insights. Global Hepatitis.
5. Co-pay Coupon Program Enrollment - Gilead Support Path®. Gilead.