Remdesivir - Generic Drug Details

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

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

Remdesivir has three hundred and forty patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for remdesivir

International Patents:	340
US Patents:	16
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	141
Patent Applications:	8,210
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for remdesivir
What excipients (inactive ingredients) are in remdesivir?	remdesivir excipients list
DailyMed Link:	remdesivir at DailyMed

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

Constraining patent/regulatory exclusivity:

9,724,360*PED

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 remdesivir

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

Sponsor	Phase
Fred Hutchinson Cancer Center	PHASE2
Gilead Sciences	PHASE2
Fundacin FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promocin de la Salud y la Ciencia	PHASE2

See all remdesivir clinical trials

Pharmacology for remdesivir

Drug Class

SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor

Anatomical Therapeutic Chemical (ATC) Classes for remdesivir

J05AB	Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for REMDESIVIR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VEKLURY	Powder for Injection	remdesivir	100 mg/vial	214787	1	2025-04-22

US Patents and Regulatory Information for remdesivir

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	9,949,994*PED				Y
Gilead Sciences Inc	VEKLURY	remdesivir	POWDER;INTRAVENOUS	214787-001	Oct 22, 2020		RX	Yes	Yes
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		DISCN	Yes	No	RE46762*PED				Y
Gilead Sciences Inc	VEKLURY	remdesivir	POWDER;INTRAVENOUS	214787-001	Oct 22, 2020		RX	Yes	Yes	11,491,169*PED				Y

EU/EMA Drug Approvals for remdesivir

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Veklury	remdesivir	EMEA/H/C/005622Veklury 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 remdesivir

Country	Patent Number	Title	Estimated Expiration
China	113620992	治疗丝状病毒科病毒感染的方法 (Method for treating filoviridae virus infection)
Mexico	2013000744	METODOS Y COMPUESTOS PARA TRATAR INFECCIONES VIRALES POR PARAMYXOVIRIDAE. (METHODS AND COMPOUNDS FOR TREATING PARAMYXOVIRIDAE VIRUS INFECTIONS.)
Taiwan	201733595	Methods for treating arenaviridae and coronaviridae virus infections
Peru	20171155	METODOS Y COMPUESTOS PARA TRATAR INFECCIONES VIRALES POR PARAMYXOVIRIDAE

Supplementary Protection Certificates for remdesivir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2595980	2020C/554	Belgium		PRODUCT NAME: REMDESIVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1459 20200703
2937350	PA2020539	Lithuania		PRODUCT NAME: REMDESIVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; 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	132020000000176	Italy		PRODUCT NAME: REMDESIVIR O SALE O ESTERE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO(VEKLURY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1459, 20200703

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Remdesivir

Last updated: July 28, 2025

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Introduction

Remdesivir (brand name Veklury) has become a focal point within the pharmaceutical landscape, primarily driven by its initial authorization for COVID-19 treatment. As an antiviral agent developed by Gilead Sciences, the drug experienced rapid market entry during the pandemic, revealing significant insights into market dynamics and its financial trajectory. This article examines the evolving factors shaping Remdesivir’s market presence, revenue prospects, competitive landscape, regulatory influences, and strategic implications for stakeholders.

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Development and Regulatory Milestones

Remdesivir was initially developed for Ebola virus disease but gained prominence for COVID-19 after evidence of antiviral activity against SARS-CoV-2 in vitro and in vivo studies. The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) in May 2020 and subsequently full approval in October 2020. The European Medicines Agency (EMA) followed with Conditional Marketing Authorization in July 2020. These regulatory approvals catalyzed immediate commercial deployment.

The drug’s approval was based on clinical trials, notably the ACTT-1 and SOLIDARITY trials, which yielded mixed results on efficacy but confirmed its capacity to shorten recovery times in hospitalized COVID-19 patients. The pivotal nature of these approvals provided a substantial revenue foundation, especially during the height of the pandemic.

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Market Dynamics

1. Pandemic-Driven Demand and Initial Surge

Remdesivir’s demand surged rapidly in 2020 and 2021, aligning with COVID-19 case trends worldwide. Governments and healthcare organizations stockpiled the drug, establishing large procurement contracts, notably in the United States, Europe, and Asia. According to Gilead, global sales reached approximately $4.6 billion in 2021, reflecting high initial demand driven by emergency use and early clinical endorsement.

2. Competitive Landscape and Therapeutic Alternatives

With the pandemic evolving, alternative and competing therapies emerged, diluting Remdesivir’s market share. Oral antiviral agents like Pfizer’s Paxlovid and Merck’s molnupiravir presented advantages via ease of administration, potentially reducing hospitalizations without requiring intravenous infusion. Additionally, the advent of monoclonal antibody therapies and other combination treatments introduced further competition.

Remdesivir’s IV route and the necessity for hospitalization limited its utility to specific patient populations. As booster vaccination campaigns reduced severe cases, demand waned, impacting the drug’s sales growth prospects.

3. Regulatory and Global Access Challenges

While initial regulatory approvals were swift, subsequent trials questioned the magnitude of clinical benefit, prompting revisions of usage guidelines. Some health authorities, including the UK’s NICE, recommended against routine use owing to limited efficacy evidence, affecting market penetration.

Additionally, access disparities influenced market dynamics. Sub-Saharan Africa, Southeast Asia, and Latin America faced logistical and financial barriers, impeding widespread deployment and thus constraining potential market expansion post-pandemic.

4. Pricing and Reimbursement Strategies

Gilead’s pricing was initially set at approximately $390 per vial (U.S.), translating into around $2,340 per treatment course. During the pandemic, the company entered into tiered pricing and negotiated reimbursement agreements with public health agencies. As demand declined, price negotiations intensified, aiming to sustain margins amid lower sales volumes.

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Financial Trajectory Analysis

1. Revenue Trends

Post-2021, Gilead's revenue from Remdesivir plateaued; estimates suggest global sales declined in 2022 and 2023 owing to reduced COVID-19 case numbers and competition. The company projects that, beyond COVID-19, the asset may find limited usage in emerging diseases but remains largely dependent on pandemic dynamics.

2. Research and Development Outlook

Gilead invested heavily in expanding the antiviral’s indications, exploring combination therapies, and developing next-generation molecules. These pipeline strategies aim to bolster long-term revenue streams, although regulatory hurdles and clinical trial outcomes remain uncertain.

3. Strategic Market Positioning

Gilead has diversified its antiviral portfolio, integrating Remdesivir into broader infectious disease frameworks. Notably, its relevance as a preparedness tool for future coronavirus outbreaks may sustain a baseline revenue, especially if regulatory agencies recognize its broader antiviral benefits.

4. Valuation and Investor Sentiment

Market valuation reflects the transient nature of Remdesivir’s COVID-19-driven revenue. Analysts increasingly perceive the drug as a "pandemic asset," with forecasts indicating a decline in sales trajectory as global vaccination and therapeutics evolve. However, strategic investments in research indicate Gilead's commitment to repurposing and broadening the application scope.

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Future Market and Financial Considerations

1. Post-Pandemic Commercial Outlook

As the COVID-19 pandemic subsides, Remdesivir's clinical value diminishes relative to oral and outpatient treatments. Its market niche likely narrows to specific hospitalized cases, with annual sales projections declining substantially from pandemic peaks.

2. Potential for New Indications

Research into the drug's efficacy against other viral pathogens, like Nipah virus or certain forms of hepatitis, offers avenues for diversification. If successful, regulatory approval for such indications could rekindle market interest.

3. Impact of Generics and Biosimilars

Gilead holds key patents expiring in the coming years; the entry of biosimilars or generics could further depress pricing, eroding profit margins. Strategic patent extensions or formulation patents may delay generic entry but only temporarily.

4. Strategic Partnerships and Licensing

Collaborations with government health agencies and regional distributors may sustain some demand. Gilead’s focus on licensing agreements for manufacturing could influence sales volume and profitability.

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Regulatory and Global Policy Impact

Regulatory stances directly influence market access and pricing. Continued evaluations by agencies like the WHO and EMA regarding COVID-19 treatment protocols impact the drug’s acceptance and reimbursement levels. The global push toward equitable access remains a pivotal factor, especially in low- and middle-income countries.

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Key Takeaways

• Pandemic catalysis: Remdesivir’s initial success hinges on emergency use approvals and urgent global needs, resulting in over $4.6 billion in 2021 sales.
• Market contraction: Post-pandemic, demand declines as oral antivirals and vaccines dominate treatment protocols.
• Competitive landscape: Alternatives with oral administration and broader efficacy threaten Remdesivir’s market share.
• Regulatory influence: Efficacy debates and guideline updates directly impact sales trajectories.
• Future potential: Diversification into other antiviral indications and strategic licensing can prolong the product's relevance, although long-term growth prospects are uncertain.

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FAQs

1. Will Remdesivir retain a significant market share post-pandemic?
While it remains a valuable treatment for hospitalized COVID-19 patients, its market share is expected to diminish with the advent of more convenient oral therapies and vaccination coverage reducing severe cases.

2. How do competition and alternative treatments affect Remdesivir’s profitability?
Oral antivirals like Paxlovid and molnupiravir, offering ease of administration and comparable efficacy, are likely to overshadow Remdesivir, leading to reduced sales and margins.

3. Are there prospects for expanding Remdesivir’s indications?
Research is ongoing into its effectiveness against other viral ailments, which could open new markets if clinical trials prove successful and regulatory pathways are favorable.

4. What are the regulatory risks impacting Remdesivir’s market?
Efficacy questions, guideline updates, and the evolving COVID-19 treatment landscape pose ongoing regulatory risks that may limit its use and reimbursement.

5. How will patent expiry affect Remdesivir’s financial outlook?
Patent expiration in key jurisdictions within the next 5-7 years could enable generic manufacturing, significantly reducing retail prices and profitability unless Gilead secures extensions or alternative formulations.

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References

[1] Gilead Sciences. Remdesivir (Veklury) Product Information. 2022.
[2] U.S. FDA. FDA Approves First COVID-19 Treatment. 2020.
[3] World Health Organization. Therapeutics and COVID-19. 2022.
[4] Gilead Sciences Quarterly Reports. 2021–2022.
[5] NICE. COVID-19 Treatment Guidelines. 2022.

This analysis aims to inform pharmaceutical and healthcare decision-makers about the complex market and financial factors influencing Remdesivir’s trajectory, supporting strategic planning amid a rapidly changing therapeutic environment.