VEMLIDY Drug Patent Profile

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

Vemlidy is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-two patent family members in fifty countries.

The generic ingredient in VEMLIDY is tenofovir alafenamide fumarate. There are forty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tenofovir alafenamide fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Vemlidy

Vemlidy was eligible for patent challenges on November 5, 2019.

There have been four 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.

There is one tentative approval for the generic drug (tenofovir alafenamide fumarate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for VEMLIDY

International Patents:	132
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	18
Patent Applications:	979
Drug Prices:	Drug price information for VEMLIDY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VEMLIDY
What excipients (inactive ingredients) are in VEMLIDY?	VEMLIDY excipients list
DailyMed Link:	VEMLIDY at DailyMed

See drug prices for VEMLIDY

Recent Clinical Trials for VEMLIDY

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

Sponsor	Phase
National Taiwan University Hospital	Phase 2
PharmaEssentia	Phase 2
Shanghai HEP Pharmaceutical Co., Ltd.	Phase 2

See all VEMLIDY clinical trials

Pharmacology for VEMLIDY

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Paragraph IV (Patent) Challenges for VEMLIDY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VEMLIDY	Tablets	tenofovir alafenamide fumarate	25 mg	208464	6	2019-11-05

US Patents and Regulatory Information for VEMLIDY

VEMLIDY is protected by three US patents and one FDA Regulatory Exclusivity.

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	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016	AB	RX	Yes	Yes					Y
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016	AB	RX	Yes	Yes
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016	AB	RX	Yes	Yes					Y
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016	AB	RX	Yes	Yes					Y

Expired US Patents for VEMLIDY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016

International Patents for VEMLIDY

When does loss-of-exclusivity occur for VEMLIDY?

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

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

Hong Kong

Hungary

India

Israel

Japan

Lithuania

Mexico

Moldova, Republic of

Montenegro

Morocco

New Zealand

Peru

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

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 VEMLIDY around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2014271320	TENOFOVIR ALAFENAMIDE HEMIFUMARATE
Canada	2893174
Croatia	P20161696
Czech Republic	304886	Prekurzory léčiv na bázi fosfonátových analogů nukleotidů a způsoby jejich výběru a přípravy (Medicament precursors based on phosphonate nucleotide analogs, processes of their selection and preparation)
Luxembourg	93029
Norway	20120466

Supplementary Protection Certificates for VEMLIDY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	1590057-4	Sweden		PRODUCT NAME: A COMBINATION OF RILPIVIRINE, OR A PHARMACEUTICAL LY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND TENOFOVIR DISOPROXIL, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737 20111128
1419152	2012C/022	Belgium		PRODUCT NAME: RILPIVIRINE EN TENOFOVIR DISOPROXIL; AUTHORISATION NUMBER AND DATE: EU/1/11/737/001 20111128
1663240	PA2015037,C1663240-2	Lithuania		PRODUCT NAME: RILPIVIRINO ARBA TERAPINIU POZIURIU PRIIMTINOS JO FORMOS, TOKIOS KAIP RILPIVIRINO DRUSKOS,ISKAITANT RILPIVIRINO HIDROCHLORIDA, TENOFOVIRO, YPAC TENOFOVIRO DIZOPROKSILIO FUMARATO, IR EMTRICITABINODERINYS; REGISTRATION NO/DATE: EU/1/11/737/001 2011-11-28, EU/1/11/737/002 20111128
1663240	PA2015038	Lithuania		PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28, EU/1/11/737/002 20111128
1301519	PA2016009	Lithuania		PRODUCT NAME: TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119
0915894	SPC/GB08/033	United Kingdom		PRODUCT NAME: TENOFOVIR DISOPROXIL AND THE SALTS (IN PARTICULAR THE FUMARATE), HYDRATES, TAUTOMERS AND SOLVATES THEREOF, TOGETHER WITH EMTRICITABINE AND EFAVIRENZ; REGISTERED: UK EU/1/07/430/001 20071213; REASON FOR LAPSE: SURRENDERED

Market Dynamics and Financial Trajectory for Vemlidy

Introduction to Vemlidy

Vemlidy, developed by Gilead Sciences, is a small molecule reverse transcriptase inhibitor used to treat chronic hepatitis B virus (HBV) infection in adults and pediatric patients 12 years and older with compensated liver disease. It is a novel, targeted prodrug of tenofovir, demonstrating antiviral efficacy similar to, but at a dose less than one-tenth of, Gilead's VIREAD (tenofovir disoproxil fumarate, TDF) 300 mg[4].

Current Market Dominance

As of 2022, Vemlidy, along with Zadaxin developed by SciClone Pharmaceuticals, dominated the hepatitis B treatment market, contributing to 71% of the sales. Vemlidy's sales for 2023 were estimated to reach $846 million, while Zadaxin's sales were projected to be $374 million. Together, these two drugs were anticipated to contribute 40% to the total HBV revenue for 2023[1].

Financial Performance of Vemlidy

• 2023 Projections: Vemlidy's sales were expected to continue rising in 2023, reaching $846 million. This growth is part of the broader trend where total product sales, excluding Veklury, increased by 7% to $24.7 billion in 2023 compared to 2022, driven by higher sales in HIV and Oncology segments[2].
• Historical Context: In 2020, other product sales, which include Vemlidy, increased by 7% to $498 million in the fourth quarter compared to the same period in 2019, primarily due to higher sales volume of Vemlidy in other international locations[3].

Future Market Projections

• Declining Sales: By 2029, Vemlidy's sales are projected to decline to $708 million at a downward Compound Annual Growth Rate (CAGR) of 3% between 2023 and 2029. This decline is anticipated due to the emergence of new therapeutic agents[1].
• Emerging Competitors: Drugs currently in the development pipeline, such as EDP-514 by Enanta Pharmaceuticals and Hengmu (tenofovir amibufenamide) by Jiangsu Hansoh Pharmaceutical Group, are forecast to become leading contenders in the market by 2029. EDP-514 and Hengmu are expected to generate revenues of $1.9 billion and $813 million, respectively, by 2029[1].

Regulatory and Developmental Activities

• Clinical Development: Vemlidy has undergone extensive clinical studies and trials, demonstrating its safety and efficacy in treating chronic HBV infection. The drug has a boxed warning regarding the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of hepatitis B[4].
• Regulatory Milestones: The regulatory landscape for Vemlidy includes various milestones and developmental activities that continue to shape its market presence. Detailed analyses of these activities provide insights into the current and future development scenario of Vemlidy[4].

Competitive Landscape

• Marketed Therapies: Currently, Vemlidy competes with other marketed therapies like Zadaxin. However, the competitive landscape is expected to change with the introduction of late-stage emerging therapies. These new therapies will focus on novel approaches to treat HBV, potentially challenging Vemlidy's market dominance[4].
• Late-Stage Emerging Therapies: The launch of new therapies in the near future will significantly impact the market, providing tough competition to Vemlidy. Companies are developing therapies that focus on improving disease conditions, assessing challenges, and seeking opportunities that could influence Vemlidy's market position[4].

Market Outlook and Forecast

• Global Market Size: The global market for hepatitis B treatments is expected to grow significantly, driven by extensive research and incremental healthcare spending. This growth will enable drug manufacturers to penetrate the market more effectively[4].
• Country-Wise Analysis: The market size of Vemlidy in key regions such as the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, Japan, and China is forecasted to provide a detailed picture of its market presence. This analysis will support decision-making processes regarding therapeutic portfolios[4].

Financial Impact on Gilead Sciences

• Revenue Contribution: Vemlidy's sales contribute significantly to Gilead Sciences' total revenue. However, the projected decline in Vemlidy sales by 2029 will be offset by growth in other segments such as HIV and Oncology[2].
• Overall Financial Health: Gilead Sciences' financial health remains robust, with total product sales, excluding Veklury, increasing by 7% in 2023. The company had $8.4 billion in cash, cash equivalents, and marketable debt securities as of December 31, 2023[2].

Key Takeaways

• Market Dominance: Vemlidy currently dominates the hepatitis B treatment market but faces declining sales due to emerging competitors.
• Financial Projections: Sales are projected to decline by 2029, but Gilead Sciences' overall financial health remains strong.
• Competitive Landscape: The introduction of new therapies will significantly impact the market, challenging Vemlidy's dominance.
• Regulatory and Developmental Activities: Ongoing clinical and regulatory activities continue to shape Vemlidy's market presence.

FAQs

Q: What is Vemlidy used for? A: Vemlidy is used to treat chronic hepatitis B virus (HBV) infection in adults and pediatric patients 12 years and older with compensated liver disease.

Q: Who developed Vemlidy? A: Vemlidy was developed by Gilead Sciences.

Q: What are the projected sales of Vemlidy for 2023? A: The projected sales of Vemlidy for 2023 are estimated to be $846 million.

Q: What is the expected impact of emerging therapies on Vemlidy's market position? A: Emerging therapies such as EDP-514 and Hengmu are expected to challenge Vemlidy's market dominance by 2029.

Q: How does Vemlidy's sales performance affect Gilead Sciences' overall revenue? A: Vemlidy's sales contribute significantly to Gilead Sciences' total revenue, but the company's overall financial health remains robust due to growth in other segments.

Cited Sources

1. Pharmaceutical Technology: "Hepatitis B Month: global market for treatments to skyrocket to $10.5 billion by 2029"[1]
2. Gilead Sciences: "Gilead Sciences Announces Fourth Quarter and Full Year 2023 Financial Results"[2]
3. Gilead Sciences: "Gilead Sciences Announces Fourth Quarter and Full Year 2020 Financial Results"[3]
4. Business Wire: "VEMLIDY for Chronic Hepatitis B Landscape: Market Size, Forecast, and Market Insight - 2032"[4]