Suppliers and packagers for generic pharmaceutical drug: CIDOFOVIR

CIDOFOVIR

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Avet Lifesciences	CIDOFOVIR	cidofovir	SOLUTION;INTRAVENOUS	202501	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-216-31	5 mL in 1 VIAL, GLASS (23155-216-31)	2012-08-06
Mylan Institutional	CIDOFOVIR	cidofovir	SOLUTION;INTRAVENOUS	201276	ANDA	Mylan Institutional LLC	67457-210-05	1 VIAL, GLASS in 1 CARTON (67457-210-05) / 5 mL in 1 VIAL, GLASS	2013-06-03

Suppliers for the Pharmaceutical Drug: Cidofovir

Last updated: July 29, 2025

Introduction

Cidofovir is an antiviral medication primarily used to treat cytomegalovirus (CMV) retinitis in immunocompromised individuals, including those with AIDS. Due to its efficacy in managing severe viral infections, cidofovir remains a critical component within the antiviral therapeutic landscape. Understanding the landscape of suppliers—ranging from patent holders to generic manufacturers—is essential for healthcare providers, pharmaceutical companies, and procurement agencies to ensure reliable access, competitive pricing, and regulatory compliance.

This analysis explores the key suppliers of cidofovir, highlighting their roles, regions of operation, supply chain dynamics, and the influence of patent status and biosimilar development.

Manufacturers of Cidofovir

Original Patent Holders and Innovator Companies

Gilead Sciences Inc. has historically been the pioneer and primary innovator in developing and commercializing cidofovir. As the original patent holder, Gilead gained exclusive rights to manufacture and commercialize the drug under the brand name Vistide. The drug received FDA approval in 1996, establishing Gilead's dominant position in the market.

Gilead's Role and Market Control:
Gilead’s extensive manufacturing infrastructure and regulatory approval in multiple jurisdictions have allowed it to maintain a leading position. Its supply chain includes active ingredients (APIs), finished formulations, and distribution networks primarily across North America, Europe, and select emerging markets.

Generic Manufacturers

Following patent expiry or licensing agreements, several pharmaceutical companies entered the market as generic producers. Their manufacturing capacity is often geographically diverse, covering North America, Europe, Asia, and other regions.

Major Generic Suppliers Include:

• Fresenius Kabi (Germany): A key player supplying generic cidofovir formulations predominantly within Europe and selected international markets.
• MediGene AG (Germany): Historically involved in developing biosimilar and generic antiviral medications, including cidofovir.
• Amneal Pharmaceuticals (United States): Has announced plans to produce generic antiviral drugs, including cidofovir, to expand access in North America.
• Hetero Labs (India): An emerging manufacturer of active pharmaceutical ingredients (APIs) and finished formulations, including antiviral agents.
• Sun Pharmaceutical Industries Ltd. (India): Noted for large-scale API production and export of generic antiviral medications.

API and Finished Product Manufacturing:
For generic physicians and hospitals, the availability of APIs is pivotal. API manufacturing often occurs in India, China, and Southeast Asia, with Indian companies like Hetero, Cipla, and Dr. Reddy's Laboratories dominating generic API supplies.

Biosimilar and Future Competitors

While biosimilars are typically associated with biologics, small-molecule antivirals like cidofovir have seen increasing off-patent manufacturing without biosimilar pathways. Nonetheless, new entrants may emerge, especially as patent protections expire or are challenged.

Supply Chain Dynamics

Regulatory Environment

Manufacturing approvals are regulated by agencies like the FDA (United States), EMA (European Union), and PMDA (Japan). Regulatory compliance ensures quality, safety, and efficacy, influencing supplier reliability.

API Sourcing and Quality Control

Quality standards for APIs directly impact supply reliability. Indian and Chinese manufacturers are major API suppliers, but recent geopolitical and regulatory developments have prompted a push for diversification to ensure consistent supply.

Market Demand and Pricing Pressure

The demand for cidofovir remains steady in specialized antiviral therapy. However, market competition, especially from generics, has pressured prices downward, increasing importance for procurement agencies to engage multiple suppliers to avoid shortages.

Supply Chain Risks

Disruptions such as geopolitical tensions, export restrictions, or raw material shortages—especially in key API-producing countries—pose risks to the global supply chain. Some manufacturers have responded by expanding manufacturing capacity or establishing regional production facilities.

Regional Perspectives

Region	Key Suppliers	Notable Trends
North America	Gilead Sciences, Amneal, Teva Pharmaceuticals	Dominant supplier market share; increasing use of generics post-patent expiry.
Europe	Fresenius Kabi, Teva, Sandoz	Growth in biosimilar and generic cidofovir supplies; focus on robust distribution channels.
Asia	Hetero Labs, Cipla, Sun Pharma	Major API players; expanding regional manufacturing capacities to meet local demand.
Middle East & Africa	Local distributors, regional suppliers	Limited supply, often reliant on imported generics.

Regulatory and Patent Status

Patent Expiry:
Gilead’s patent protection for cidofovir has expired in many jurisdictions, paving the way for generic manufacturing. The expiration date varies by country, often occurring within the last decade, with some regions still maintaining certain patent extensions.

Regulatory Approvals:
Generic manufacturers must obtain approvals through regulatory pathways such as ANDA (Abbreviated New Drug Application) in the US or comparable processes elsewhere, ensuring bioequivalence and safety.

Future Outlook and Market Trends

• Market Expansion: As HIV/AIDS treatment protocols expand globally, especially in low- and middle-income countries, demand for affordable cidofovir is expected to increase.
• Generic Proliferation: Increased competition from generic manufacturers may further reduce prices, improving accessibility.
• Supply Chain Optimization: Manufacturers are investing in diversified sourcing and local production to mitigate risks and meet regulatory standards.
• Innovations: Development of alternative antivirals and formulation improvements may influence the market dynamics of cidofovir suppliers.

Key Takeaways

• Gilead Sciences remains a significant supplier, holding exclusive rights during the patent period, but the landscape is shifting toward a proliferation of generic manufacturers.
• Indian and Chinese pharmaceutical firms dominate API production for cidofovir, with regional and global suppliers providing finished formulations.
• Ensuring regulatory compliance, quality assurance, and diversified sourcing is crucial for procurement agencies to mitigate supply risks.
• Patent expiration has increased competition, leading to cost reductions and broader access, especially in emerging markets.
• Ongoing market and regulatory developments suggest a growing, competitive landscape for cidofovir suppliers, emphasizing the importance of strategic supplier relationships.

FAQs

1. Who are the primary suppliers of cidofovir globally?
Gilead Sciences is the original patent holder and primary supplier, with several generics manufacturers such as Fresenius Kabi, Amneal, Hetero Labs, and Sun Pharma active in producing both APIs and finished formulations.

2. When did the patent for cidofovir expire, enabling generic manufacturing?
The patent expiry varies by region but generally occurred within the last decade, opening the market for numerous generic producers.

3. Are there regional differences in cidofovir suppliers?
Yes; North America mainly relies on Gilead and US-based generics, Europe on companies like Fresenius Kabi, and Asia on Indian and Chinese manufacturers for APIs and generics.

4. What are the key risks related to cidofovir supply chains?
Risks include geopolitical tensions, export restrictions, raw material shortages, and factory disruptions, especially in high-volume API-producing countries like India and China.

5. How might future patent expirations affect cidofovir supply?
Further patent expirations could introduce more competitors, lowering prices and improving access, but also necessitating vigilant quality and regulatory oversight to maintain supply integrity.

References

1. U.S. Food and Drug Administration (FDA). Vistide (Cidofovir) approval details.
2. European Medicines Agency (EMA). Summary of product characteristics for cidofovir-based products.
3. Gilead Sciences Inc. Annual reports and patent status disclosures.
4. Indian Patent Office. Patent expiry dates for cidofovir.
5. Market reports on antiviral drug manufacturing and generic pharmaceutical supply chains.