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 twenty-six patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for remdesivir

International Patents:	326
US Patents:	16
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	133
Patent Applications:	67
What excipients (inactive ingredients) are in remdesivir?	remdesivir excipients list
DailyMed Link:	remdesivir at DailyMed

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

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
University of Exeter	Phase 4
University Hospitals of Derby and Burton NHS Foundation Trust	Phase 4
University of Derby	Phase 4

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

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

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/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 remdesivir

Country	Patent Number	Title	Estimated Expiration
South Korea	101681559
Taiwan	I767201
Taiwan	I740546
Ukraine	121485	СПОСОБИ ЛІКУВАННЯ ВІРУСНИХ ІНФЕКЦІЙ FILOVIRIDAE (METHODS FOR TREATING FILOVIRIDAE VIRUS INFECTIONS)
Australia	2015339222	Methods for the preparation of ribosides
Philippines	12020551055	METHODS FOR TREATING FILOVIRIDAE VIRUS INFECTIONS

Supplementary Protection Certificates for remdesivir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2937350	C20200043 00387	Estonia		PRODUCT NAME: REMDESIVIIR;REG NO/DATE: EU/1/20/1459 03.07.2020
2937350	PA2020539,C2937350	Lithuania		PRODUCT NAME: REMDESIVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1459 20200703
2595980	122020000084	Germany		PRODUCT NAME: REMDESIVIR ODER PHARMAZEUTISCH AKZEPTABLES SALZ ODER PHARMAZEUTISCH AKZEPTABLER ESTER DAVON; REGISTRATION NO/DATE: EU/1/20/1459 20200703
2595980	2090055-1	Sweden		PRODUCT NAME: REMDESIVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REG. 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
2937350	LUC00193	Luxembourg		PRODUCT NAME: REMDESIVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/20/1459 20200703

Remdesivir Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Remdesivir

Introduction to Remdesivir

Remdesivir, developed by Gilead Sciences, is a critical antiviral medication that has gained significant attention and usage during the COVID-19 pandemic. Here, we delve into the market dynamics and financial trajectory of remdesivir, exploring its growth, challenges, and future outlook.

Market Size and Growth

The remdesivir market has experienced exponential growth in recent years. As of 2023, the market size was valued at $4.95 billion, and it is projected to grow to $6.49 billion in 2024 at a compound annual growth rate (CAGR) of 31.2%[1].

By 2028, the market is expected to reach $14.12 billion, growing at a CAGR of 21.4%. This robust growth is driven by ongoing COVID-19 response efforts, emerging variants, global vaccination campaigns, pandemic preparedness, and global health initiatives[1].

Segmentation of the Remdesivir Market

The remdesivir market is segmented based on several key factors:

• Route of Administration: The market is divided into oral and intravenous administration routes[1].
• Dosage Form: Remdesivir is available in various forms, including tablets, frozen solutions, and lyophilized solutions[1].
• Distribution Channel: The drug is distributed through hospitals, clinics, drug stores/pharmacies, online channels, and other distribution channels[1].

Key Drivers of Market Growth

Several factors are driving the growth of the remdesivir market:

• Government Support and Expenditure: Government spending on public health initiatives, research, and purchasing power has significantly contributed to the availability and affordability of remdesivir. Increased government expenditure on services and capital projects has been instrumental in this growth[1].
• Clinical Trials and Research: Ongoing clinical trials and research on remdesivir have enhanced its credibility and expanded its potential uses, further driving market growth[1].
• Global Health Initiatives: Global efforts to combat COVID-19, including vaccination campaigns and pandemic preparedness, have increased the demand for remdesivir[1].

Pricing and Cost-Effectiveness

The pricing of remdesivir has been a subject of considerable debate:

• Announced Pricing: Gilead Sciences announced a US price of $3,120 for a 5-day course of remdesivir, with discounts for certain federal government programs. This price is considered relatively reasonable compared to initial speculations of up to $5,000 per treatment course[2].
• ICER’s Assessment: The Institute for Clinical and Economic Review (ICER) suggested that a cost-effective price range for remdesivir would be between $2,520 and $2,800, assuming a 5-day treatment course and incorporating the use of dexamethasone as standard care[2][3].
• Cost-Recovery Estimates: ICER also estimated that a cost-recovery price range could be between $1,110 and $1,600 per treatment course, considering Gilead’s forecasted development expenses and expected sales[3].

Challenges and Limitations

Despite the growth, the remdesivir market faces several challenges:

• High Cost: The high cost associated with remdesivir is a significant barrier to its widespread adoption. The estimated price range of $4,580 to $5,080 per treatment course is considered high and could hinder market growth[1][2].
• Supply Chain and Transportation Issues: The pandemic has disrupted supply chains and transportation, posing challenges to the production and distribution of remdesivir[4].
• Safety and Efficacy Concerns: There is ongoing debate about the safety and efficacy of remdesivir, particularly regarding its mortality benefits, which can affect market confidence[4].

Regional Insights

The global remdesivir market is geographically diverse:

• North America: This region dominates the global remdesivir market due to the high demand driven by the COVID-19 pandemic. North America is expected to hold the largest market share by 2029[4].
• Europe: Europe is expected to grow rapidly, driven by the European Medicines Agency's (EMA) recommendation for the use of remdesivir in COVID-19 treatment[4].
• Asia-Pacific: The Asia-Pacific region is also experiencing rapid growth due to the extensive use of remdesivir in countries like China, Japan, and India[4].

Future Outlook and Trends

Several trends are expected to shape the future of the remdesivir market:

• Personalized Medicine: There is a growing trend towards personalized medicine, which could influence the development and use of remdesivir[1].
• Combination Therapies: Research on combination therapies involving remdesivir and other treatments, such as dexamethasone, is likely to continue and impact market dynamics[1][2].
• Production Scalability: Efforts to increase production scalability will be crucial in meeting the global demand for remdesivir[1].
• Telemedicine and Remote Monitoring: The integration of telemedicine and remote monitoring could enhance the accessibility and effectiveness of remdesivir treatment[1].

Research and Development

Significant investment in research and development is a key driver of the remdesivir market:

• New Indications: Research into new indications for remdesivir beyond COVID-19 could expand its market potential[1].
• Alternative Antiviral Therapies: The exploration of alternative antiviral therapies will continue to influence the market landscape[1].

Key Takeaways

• The remdesivir market is experiencing rapid growth driven by government support, clinical trials, and global health initiatives.
• Pricing remains a critical issue, with ongoing debates about cost-effectiveness and the need for iterative health technology assessments.
• Regional demand varies, with North America leading the market and significant growth expected in Europe and the Asia-Pacific region.
• Future trends include personalized medicine, combination therapies, and increased production scalability.

FAQs

Q: What is the current market size of remdesivir and its projected growth? A: The remdesivir market size was $4.95 billion in 2023 and is projected to grow to $6.49 billion in 2024, with a CAGR of 31.2%. By 2028, it is expected to reach $14.12 billion at a CAGR of 21.4%[1].

Q: What are the key drivers of the remdesivir market growth? A: Key drivers include government support and expenditure, ongoing clinical trials and research, and global health initiatives such as vaccination campaigns and pandemic preparedness[1].

Q: What is the pricing strategy for remdesivir? A: Gilead Sciences has set a US price of $3,120 for a 5-day course of remdesivir, with discounts for certain federal government programs. ICER suggests a cost-effective price range of $2,520 to $2,800[2][3].

Q: What are the challenges facing the remdesivir market? A: High costs, supply chain and transportation issues, and concerns over safety and efficacy are significant challenges[1][4].

Q: Which regions are expected to dominate the remdesivir market in the future? A: North America is expected to hold the largest market share, followed by significant growth in Europe and the Asia-Pacific region[4].

Sources

1. The Business Research Company: "Global Remdesivir Market Report 2024"
2. ICER: "ICER Comments on Gilead's Pricing for Remdesivir"
3. Pharmaceutical Technology: "The case of remdesivir: How do you calculate the cost of a pandemic drug"
4. Maximize Market Research: "Remdesivir Market: Global Industry Analysis, Forecast (2023-2029)"
5. PubMed: "The Cost-Effectiveness of Remdesivir for Hospitalized Patients With COVID-19"