VEKLURY Drug Patent Profile

Which patents cover Veklury, and what generic alternatives are available?

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

This drug has three hundred and twenty-nine patent family members in forty-eight countries.

The generic ingredient in VEKLURY is remdesivir. One supplier is listed for this compound. Additional details are available on the remdesivir profile page.

DrugPatentWatch^® Generic Entry Outlook for Veklury

Veklury was eligible for patent challenges on October 22, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 29, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VEKLURY

International Patents:	329
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	6
Patent Applications:	2,734
What excipients (inactive ingredients) are in VEKLURY?	VEKLURY excipients list
DailyMed Link:	VEKLURY at DailyMed

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

NDA:

214787

Dosage:

POWDER;INTRAVENOUS

^*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 VEKLURY

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

Sponsor	Phase
Peninsula Clinical Trials Unit	Phase 4
University of Exeter	Phase 4
University Hospitals of Derby and Burton NHS Foundation Trust	Phase 4

See all VEKLURY clinical trials

Pharmacology for VEKLURY

Drug Class

SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor

US Patents and Regulatory Information for VEKLURY

VEKLURY is protected by sixteen US patents and eight FDA Regulatory Exclusivities.

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	VEKLURY	remdesivir	POWDER;INTRAVENOUS	214787-001	Oct 22, 2020		RX	Yes	Yes					Y
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		RX	Yes	Yes
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		RX	Yes	Yes					Y
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		RX	Yes	Yes
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		RX	Yes	Yes					Y
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		RX	Yes	Yes					Y
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		RX	Yes	Yes					Y

EU/EMA Drug Approvals for VEKLURY

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Veklury	remdesivir	EMEA/H/C/005622 Veklury is indicated for the treatment of coronavirus disease 2019 (COVID 19) in:adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment)adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19	Authorised	no	no	no	2020-07-03

International Patents for VEKLURY

When does loss-of-exclusivity occur for VEKLURY?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Moldova, Republic of

Montenegro

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Turkey

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 VEKLURY around the world.

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	3076	Carba-nucleoside analogs for antiviral treatment
China	105343098
Denmark	2268642
Denmark	3785717
European Patent Office	4036099	MÉTHODES POUR LA PRÉPARATION DE RIBOSIDES (METHODS FOR THE PREPARATION OF RIBOSIDES)
Japan	5425187
Japan	2023528810	レムデシビル治療方法

Supplementary Protection Certificates for VEKLURY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2595980	122020000084	Germany		PRODUCT NAME: REMDESIVIR ODER PHARMAZEUTISCH AKZEPTABLES SALZ ODER PHARMAZEUTISCH AKZEPTABLER ESTER DAVON; REGISTRATION NO/DATE: EU/1/20/1459 20200703
2595980	2020/061	Ireland		PRODUCT NAME: REMDESIVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTRATION NO/DATE: EU/1/20/1459 20200703
2595980	301084	Netherlands		PRODUCT NAME: REMDESIVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; REGISTRATION NO/DATE: EU/1/20/1459 20200703
2595980	C02595980/01	Switzerland		PRODUCT NAME: REMDESIVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68043 25.11.2020
2595980	C202030068	Spain		PRODUCT NAME: REMDESIVIR O UNA SAL O UN ESTER FARMACEUTICAMENTE ACEPTABLES DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1459; DATE OF AUTHORISATION: 20200703; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1459; DATE OF FIRST AUTHORISATION IN EEA: 20200703
2937350	CA 2020 00060	Denmark		PRODUCT NAME: REMDESIVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1459 20200703
2595980	SPC/GB20/072	United Kingdom		PRODUCT NAME: REMDESIVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTERED: UK EU/1/20/1459 (NI) 20200703; UK PL GB11972/0036 20200703

Market Dynamics and Financial Trajectory of Veklury (Remdesivir)

Introduction

Veklury, also known as remdesivir, is an antiviral medication developed by Gilead Sciences, primarily used for the treatment of COVID-19 in hospitalized patients. The drug's market dynamics and financial performance have been significantly influenced by the evolving COVID-19 pandemic, vaccination rates, and healthcare policies.

Approval and Initial Impact

Veklury was approved by the FDA in May 2020, and its initial sales were robust due to the high demand for COVID-19 treatments. In the third quarter of 2020, Veklury generated $1.9 billion in sales, a figure that surprised Wall Street analysts and helped Gilead revise its annual sales projections upward[4].

Sales Performance Over Time

2020 and Early 2021

During the initial phases of the pandemic, Veklury saw significant sales. In the third quarter of 2020, it generated $1.9 billion, and by the end of 2020, it had contributed substantially to Gilead's revenue. However, as vaccination rates increased and COVID-19 hospitalizations decreased, Veklury's sales began to decline. By the second quarter of 2021, sales had dropped to $829 million[4].

2021 and the Delta Variant

The resurgence of COVID-19 cases due to the delta variant in the summer of 2021 led to a temporary rebound in Veklury sales. In the third quarter of 2021, Veklury sales surged to $1.9 billion again, driven by its effectiveness against the delta variant and high hospitalization rates[4].

2022

In 2022, Veklury sales continued to decline as COVID-19 hospitalizations decreased. Full-year 2022 sales of Veklury were $3.9 billion, a 30% decrease from 2021. This decline was primarily driven by lower rates of COVID-19 related hospitalizations[5].

2023

The trend of declining sales continued into 2023. Full-year 2023 Veklury sales decreased by 44% to $2.2 billion compared to 2022, largely due to lower rates of COVID-19 related hospitalizations across all regions[1].

Factors Influencing Sales

COVID-19 Hospitalization Rates

The primary factor influencing Veklury sales is the rate of COVID-19 related hospitalizations. As hospitalization rates decrease, so do the sales of Veklury. This is evident from the significant drops in sales in 2022 and 2023 as the pandemic's severity waned[1][5].

Vaccination and Alternative Treatments

The availability, uptake, and effectiveness of COVID-19 vaccinations and alternative treatments also impact Veklury sales. As more people get vaccinated and alternative treatments become available, the demand for Veklury decreases[1].

Healthcare Policies and Pricing Dynamics

Healthcare policies and pricing dynamics in different regions also affect Veklury sales. For instance, changes in pricing and reimbursement policies can influence the drug's adoption and sales[3].

Financial Impact on Gilead Sciences

Revenue and EPS

The fluctuations in Veklury sales have had a significant impact on Gilead Sciences' financial performance. In the fourth quarter of 2023, total revenue decreased by 4% to $7.1 billion, partly due to lower Veklury sales. However, this was partially offset by higher sales in Oncology and HIV products[1].

Diluted EPS for the full year 2023 increased to $4.50, despite lower Veklury sales, due to factors such as lower IPR&D impairment expenses and higher interest income[1].

Non-GAAP EPS

Non-GAAP diluted EPS for the full year 2023 decreased to $6.72, primarily driven by higher total costs and expenses, as well as lower Veklury sales. However, this was partially offset by a decrease in tax reserves and higher interest income[1].

Market Share and Competitive Landscape

Veklury has maintained a significant market share in the treatment of hospitalized COVID-19 patients. Despite the decline in sales, it remains an essential treatment option, especially in regions with high hospitalization rates. However, the competitive landscape is evolving with the development of other COVID-19 treatments and the impact of vaccination efforts[4].

Future Outlook

Declining Sales Projections

Analysts project that Veklury sales will continue to decline as the pandemic's impact diminishes. By 2025, Veklury is expected to contribute only $86 million in sales, a significant drop from its peak[4].

Diversification of Gilead's Portfolio

Gilead Sciences is diversifying its product portfolio to mitigate the impact of declining Veklury sales. The company has seen growth in its HIV and Oncology segments, with products like Biktarvy, Descovy, Yescarta, and Trodelvy performing well. This diversification is crucial for maintaining revenue stability[1][3].

Key Takeaways

• Veklury Sales Trend: Veklury sales have been highly volatile, influenced by COVID-19 hospitalization rates, vaccination efforts, and alternative treatments.
• Financial Impact: The decline in Veklury sales has affected Gilead Sciences' revenue and EPS, though the company has managed to offset some of this impact through growth in other product segments.
• Market Dynamics: The drug's market share remains significant but is expected to decline as the pandemic's severity wanes.
• Future Outlook: Veklury sales are projected to decline further, emphasizing the need for Gilead to continue diversifying its product portfolio.

FAQs

Q: What is Veklury used for?

A: Veklury, also known as remdesivir, is an antiviral medication used primarily for the treatment of COVID-19 in hospitalized patients.

Q: How have Veklury sales been affected by the COVID-19 pandemic?

A: Veklury sales have been highly volatile, increasing during periods of high COVID-19 hospitalizations and decreasing as hospitalization rates drop.

Q: What factors influence Veklury sales?

A: Key factors include COVID-19 hospitalization rates, vaccination rates, availability of alternative treatments, and healthcare policies.

Q: How has the decline in Veklury sales impacted Gilead Sciences' financial performance?

A: The decline has affected Gilead's revenue and EPS, though the company has offset some of this impact through growth in other product segments like HIV and Oncology.

Q: What is the projected future outlook for Veklury sales?

A: Analysts expect Veklury sales to continue declining, with projections suggesting minimal contributions by 2025.