CIDOFOVIR - Generic Drug Details

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

Cidofovir is the generic ingredient in two branded drugs marketed by Avet Lifesciences, Mylan Institutional, and Gilead Sciences Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for cidofovir. Two suppliers are listed for this compound.

Summary for CIDOFOVIR

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	43
Patent Applications:	5,926
Drug Prices:	Drug price trends for CIDOFOVIR
What excipients (inactive ingredients) are in CIDOFOVIR?	CIDOFOVIR excipients list
DailyMed Link:	CIDOFOVIR at DailyMed

See drug prices for CIDOFOVIR

Recent Clinical Trials for CIDOFOVIR

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

Sponsor	Phase
University Hospital, Lille	Phase 2
Biotest	Phase 2
Assistance Publique - Hôpitaux de Paris	Phase 3

See all CIDOFOVIR clinical trials

Pharmacology for CIDOFOVIR

Drug Class	Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor
Mechanism of Action	DNA Polymerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CIDOFOVIR

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 CIDOFOVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avet Lifesciences	CIDOFOVIR	cidofovir	INJECTABLE;INJECTION	202501-001	Jul 26, 2012	AP	RX	No	No
Gilead Sciences Inc	VISTIDE	cidofovir	INJECTABLE;INJECTION	020638-001	Jun 26, 1996		DISCN	Yes	No
Mylan Institutional	CIDOFOVIR	cidofovir	INJECTABLE;INJECTION	201276-001	Jun 27, 2012	AP	RX	No	Yes

Expired US Patents for CIDOFOVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	VISTIDE	cidofovir	INJECTABLE;INJECTION	020638-001	Jun 26, 1996	5,142,051

EU/EMA Drug Approvals for CIDOFOVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences International Limited	Vistide	cidofovir	EMEA/H/C/000121 Vistide is indicated for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction. Vistide should be used only when other agents are considered unsuitable.,	Withdrawn	no	no	no	1997-04-23

CIDOFOVIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cidofovir

Introduction to Cidofovir

Cidofovir, marketed under the brand name VISTIDE, is an antiviral medication used primarily for the treatment of cytomegalovirus (CMV) retinitis and other viral infections. Here, we will delve into the market dynamics and financial trajectory of cidofovir, highlighting its current status, growth prospects, and key factors influencing its market.

Market Size and Growth Projections

The cidofovir market is anticipated to experience significant growth over the forecast period from 2024 to 2031. The market size is expected to expand at a remarkable CAGR, driven by increasing demand for effective antiviral treatments[1].

• Global Market Size: The cidofovir market is valued in USD million and is segmented by type (solution, powder) and application (treatment of CMV retinitis, local treatment of warts, other uses).
• Forecast Period: The market is projected to grow substantially from 2024 to 2031, with a sustained expansion expected throughout this period[1].

Key Market Drivers

Several factors are driving the growth of the cidofovir market:

Increasing Incidence of CMV Infections

The rising incidence of CMV infections, particularly among immunocompromised populations such as organ transplant recipients and individuals with HIV/AIDS, is a major driver. Improved diagnostics have enhanced detection rates, leading to increased demand for effective antiviral treatments like cidofovir[3][4].

Growing Healthcare Expenditure

Increased financial allocations to healthcare, especially for infectious diseases like CMV, are driving the market. Expanded healthcare budgets and growing emphasis on advanced antiviral therapies contribute to the market's growth trajectory[3].

Transplantation Activities

The surge in organ and stem cell transplants has increased the incidence of CMV infections among recipients, fueling the demand for effective CMV treatment options. Antiviral drugs like cidofovir play a crucial role in managing these infections[3][4].

Market Segmentation

The cidofovir market is segmented based on several criteria:

By Type

• Solution: This form is commonly used for intravenous administration.
• Powder: Used for reconstitution before administration[1].

By Application

• Treatment of CMV Retinitis: A primary use for cidofovir, especially in immunocompromised patients.
• Local Treatment of Warts: Cidofovir is also used for the treatment of certain types of warts.
• Other Applications: Includes other viral infections where cidofovir may be prescribed[1].

By Geography

• North America: Dominates the market due to high awareness and advanced healthcare infrastructure.
• Europe: Significant market share due to high prevalence of CMV infections.
• Asia-Pacific: Growing rapidly due to increasing healthcare expenditure and rising incidence of CMV infections.
• South America and Middle-East & Africa: Also experiencing growth, though at a slower pace compared to other regions[1][4].

Financial Performance and Revenue

Historically, cidofovir has contributed significantly to the revenue of pharmaceutical companies like Gilead Sciences.

Historical Revenue

In the third quarter of 2000, Gilead Sciences reported $1.3 million in product sales revenue from VISTIDE (cidofovir), which was part of their total product sales revenue of $37.4 million[2].

Current and Projected Revenue

The cidofovir market is expected to generate substantial revenue during the forecast period. The market size is projected to grow from USD millions in 2023 to a significantly higher value by 2031, driven by the factors mentioned above[1].

Key Players and Competitive Landscape

Several key players are active in the cidofovir market:

Major Companies

• Gilead Sciences: A leading player in the antiviral market, including cidofovir.
• Emcure Pharma: Another significant player with a presence in the cidofovir market.
• Mylan: Known for its generic and branded pharmaceuticals, including antivirals.
• Tillomed Pharma: Specializes in dermatological treatments, including those involving cidofovir[1].

Competitive Strategies

Companies are focusing on research and development, product innovation, joint ventures, mergers & acquisitions, and collaborations to enhance their market position. For instance, Merck & Co., Inc. and Shire have been involved in pivotal Phase 3 clinical studies for new antiviral drugs targeting CMV infections[4].

Challenges and Restraints

Despite the growth prospects, the cidofovir market faces several challenges:

High Cost of Treatment

The high cost of antiviral treatments, including cidofovir, can impede market growth. This is particularly significant in regions with limited healthcare budgets and reimbursement policies[3][4].

Limited Treatment Options

The limited number of treatment options for CMV infections and the expiry of patented drugs can also hinder market growth. However, increasing government support and the development of healthcare infrastructure may mitigate these challenges[4].

Conclusion

The cidofovir market is poised for significant growth driven by increasing demand for antiviral treatments, rising healthcare expenditure, and the growing incidence of CMV infections. Despite challenges such as high treatment costs, the market is expected to expand substantially over the forecast period.

Key Takeaways

• Market Growth: The cidofovir market is expected to grow at a remarkable CAGR from 2024 to 2031.
• Key Drivers: Increasing incidence of CMV infections, growing healthcare expenditure, and rising transplantation activities.
• Market Segmentation: By type (solution, powder), application (CMV retinitis, local treatment of warts), and geography (North America, Europe, Asia-Pacific, etc.).
• Financial Performance: Significant revenue generation expected, with major players like Gilead Sciences contributing to the market.
• Challenges: High cost of treatment and limited treatment options.

FAQs

What are the primary applications of cidofovir?

Cidofovir is primarily used for the treatment of cytomegalovirus (CMV) retinitis and local treatment of certain types of warts.

Which regions dominate the cidofovir market?

North America and Europe dominate the cidofovir market due to high awareness and advanced healthcare infrastructure.

What are the key drivers of the cidofovir market?

The key drivers include the increasing incidence of CMV infections, growing healthcare expenditure, and rising transplantation activities.

Who are the major players in the cidofovir market?

Major players include Gilead Sciences, Emcure Pharma, Mylan, and Tillomed Pharma.

What are the challenges facing the cidofovir market?

The high cost of treatment and limited treatment options are significant challenges facing the cidofovir market.

Sources

1. Market Research Intellect: Global Cidofovir Market Size, Trends and Projections.
2. Gilead Sciences: Gilead Sciences Announces Third Quarter 2000 Financial Results.
3. Polaris Market Research: Cytomegalovirus Treatment Market Size, Share, Global Analysis.
4. GlobeNewswire: Global Cytomegalovirus Treatment Market is Expected to Reach USD 335.49 Million by 2025.