Suppliers and packagers for generic pharmaceutical drug: PROPOFOL

PROPOFOL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627	NDA	Fresenius Kabi USA, LLC	63323-269-16	10 VIAL in 1 BOX (63323-269-16) / 10 mL in 1 VIAL (63323-269-06)	2009-11-17
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627	NDA	Fresenius Kabi USA, LLC	63323-269-37	10 VIAL in 1 BOX (63323-269-37) / 20 mL in 1 VIAL (63323-269-25)	2009-11-17
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627	NDA	Fresenius Kabi USA, LLC	63323-269-57	20 VIAL in 1 BOX (63323-269-57) / 50 mL in 1 VIAL (63323-269-23)	2009-11-17
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627	NDA	Fresenius Kabi USA, LLC	63323-269-67	10 VIAL in 1 BOX (63323-269-67) / 100 mL in 1 VIAL (63323-269-21)	2009-11-17
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627	NDA	Fresenius Kabi USA, LLC	63323-269-59	20 VIAL in 1 BOX (63323-269-59) / 50 mL in 1 VIAL (63323-269-45)	2009-11-17

Propofol Suppliers: Market Landscape and Patent Considerations

Last updated: February 19, 2026

This analysis details the key suppliers of propofol, a widely used anesthetic, and examines the patent landscape affecting its market. It identifies major manufacturers, explores their production capacities and geographical reach, and highlights critical intellectual property milestones and potential challenges.

Who are the Primary Manufacturers of Propofol?

The global propofol market is dominated by a consolidated group of pharmaceutical manufacturers. Production is concentrated among companies with established sterile injectable manufacturing capabilities and significant regulatory experience.

Key manufacturers include:

• Fresenius Kabi: A major player in anesthetics and intensive care medicine. The company offers propofol formulations in various concentrations and delivery systems. Fresenius Kabi operates manufacturing facilities in Europe and North America.
• Hikma Pharmaceuticals: A global pharmaceutical company specializing in generic and branded injectable medicines. Hikma has a substantial presence in the propofol market, with production capabilities in its EU and US facilities.
• Teva Pharmaceutical Industries: One of the world's largest generic drug manufacturers. Teva supplies propofol to numerous markets globally, leveraging its extensive distribution network.
• Baxter International: A leading healthcare company that manufactures and markets a broad range of products for use in hospitals and other healthcare settings. Baxter's portfolio includes propofol-based anesthetic agents.
• Cipla: An Indian multinational pharmaceutical company. Cipla produces propofol for both domestic and international markets, often focusing on cost-effective generic formulations.

These five companies collectively represent a significant portion of the global propofol supply. Their production capacity and market access are critical factors influencing drug availability and pricing.

What is the Current Patent Status of Propofol?

Propofol (2,6-diisopropylphenol) itself is an old molecule, and its composition of matter patents expired decades ago. However, the patent landscape is dynamic, with new intellectual property focusing on various aspects of its formulation, delivery, manufacturing processes, and novel therapeutic uses.

Key Patent Areas and Their Impact:

• Formulation Patents: These patents cover specific compositions of propofol, including emulsifying agents, stabilizers, and preservatives. For example, early patents focused on stable oil-in-water emulsions necessary for intravenous administration [1]. More recent patents may address improved emulsion stability, reduced pain on injection, or enhanced pharmacokinetic profiles.
  • Example: A patent might describe a specific lipid emulsion composition that minimizes the risk of microbial contamination or reduces the incidence of injection site irritation. Such patents can provide market exclusivity for a period, even for a generic drug.
• Manufacturing Process Patents: Innovations in the synthesis or purification of propofol can be patented. These may offer more efficient, cost-effective, or environmentally friendly production methods.
  • Example: A patent could detail a novel catalytic process for propofol synthesis that increases yield or purity. Companies holding such patents might leverage them to gain a competitive advantage or license the technology to other manufacturers.
• Delivery System Patents: Patents can also protect novel devices or methods for administering propofol. This might include pre-filled syringes, specialized infusion pumps, or formulations designed for specific administration routes.
  • Example: A patent might claim a pre-filled syringe with a specific locking mechanism or a controlled-release infusion system designed to maintain a steady anesthetic plane.
• Therapeutic Use Patents: While propofol is primarily used for anesthesia and sedation, patents can be granted for new therapeutic indications. Research into propofol's potential neuroprotective, anti-inflammatory, or anti-cancer properties could lead to new patentable uses.
  • Example: A patent might cover the use of propofol in treating specific neurological conditions, such as stroke or traumatic brain injury, based on its demonstrated biological effects beyond anesthesia.

Notable Patent Expirations and Their Implications:

The expiration of key formulation and manufacturing patents has historically opened the door for increased generic competition. This has led to a more competitive market and often reduced prices. However, companies continue to file for new patents on incremental innovations, extending effective market exclusivity for certain proprietary aspects of their propofol products.

Recent Patent Activity:

A review of recent patent filings reveals ongoing innovation in propofol formulations aimed at addressing known limitations. This includes efforts to:

• Reduce Injection Pain: Patents explore different emulsifier combinations or pH adjustments to mitigate the stinging sensation associated with propofol injection.
• Enhance Microbial Stability: Novel preservative systems or manufacturing techniques aim to reduce the risk of microbial contamination, a critical safety concern for intravenous drugs.
• Develop Novel Formulations: Research into alternative delivery methods or formulations for specific patient populations (e.g., pediatric patients) may lead to new patentable inventions.

What are the Regulatory Considerations for Propofol Manufacturing?

The manufacturing of propofol is subject to stringent regulatory oversight by health authorities worldwide. Compliance with Good Manufacturing Practices (GMP) is mandatory for all propofol producers.

Key regulatory aspects include:

• Sterility Assurance: Propofol is administered intravenously, requiring strict controls to ensure the absence of microbial contamination. Manufacturing facilities must adhere to rigorous aseptic processing standards.
• Active Pharmaceutical Ingredient (API) Purity: The purity of the propofol API must meet pharmacopoeial standards (e.g., USP, EP). Impurities can affect drug safety and efficacy.
• Excipient Quality: All inactive ingredients used in propofol formulations (e.g., soybean oil, glycerol, egg lecithin) must also meet strict quality and safety standards.
• Stability Testing: Manufacturers must conduct extensive stability studies to ensure the drug maintains its quality, safety, and efficacy throughout its shelf life under specified storage conditions.
• Site Inspections: Regulatory agencies conduct regular inspections of manufacturing sites to verify compliance with GMP regulations. Failure to comply can result in product recalls, manufacturing holds, or import alerts.

United States FDA Oversight:

In the U.S., the Food and Drug Administration (FDA) oversees propofol manufacturing. Manufacturers must file New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs) for propofol products. ANDAs for generic propofol require demonstration of bioequivalence to the reference listed drug.

European EMA Oversight:

In Europe, the European Medicines Agency (EMA) and national competent authorities regulate propofol. Marketing Authorization Applications (MAAs) are required, and manufacturing sites are subject to inspection by national authorities.

Global Supply Chain Challenges:

Disruptions in the global supply chain, including raw material shortages, manufacturing issues, or logistical challenges, can impact propofol availability. Regulatory bodies monitor supply levels and work with manufacturers to mitigate shortages.

How Do Manufacturing Costs and Pricing Interact in the Propofol Market?

The cost of propofol production is influenced by several factors, including raw material sourcing, manufacturing complexity, regulatory compliance, and economies of scale. The market structure, characterized by a few dominant players and significant generic competition, also plays a crucial role in pricing.

Cost Drivers:

• Raw Materials: The primary components, including propofol API and lipid emulsion ingredients, represent a significant cost. Sourcing high-purity, pharmaceutical-grade materials is essential.
• Manufacturing Overhead: Operating sterile injectable manufacturing facilities involves substantial costs related to specialized equipment, highly trained personnel, quality control, and energy.
• Regulatory Compliance: Meeting stringent GMP standards and undergoing regulatory audits incurs ongoing costs.
• R&D Investment: While propofol is a mature drug, investment in new formulations or manufacturing processes still requires significant capital.
• Distribution and Logistics: Maintaining a cold chain and ensuring timely delivery to hospitals and clinics adds to the overall cost.

Pricing Dynamics:

• Generic Competition: The presence of multiple generic propofol manufacturers exerts downward pressure on prices. Once patents expire, competitors can enter the market, leading to price erosion.
• Brand vs. Generic: Branded propofol products may command higher prices, particularly if they are associated with specific delivery systems or formulations with perceived advantages. However, the price difference between branded and generic versions of the same formulation is often minimal in competitive markets.
• Volume and Negotiation: Large hospital systems and group purchasing organizations negotiate significant volume discounts, impacting the effective price paid for propofol.
• Supply and Demand: Shortages can temporarily lead to price increases. Conversely, oversupply can depress prices.

The market for propofol is highly competitive, with manufacturers constantly seeking efficiencies to maintain profitability. The pricing of propofol is a sensitive issue, particularly in hospital settings where it is a high-volume anesthetic agent.

What are the Key Trends and Future Outlook for Propofol Suppliers?

The propofol market is expected to remain robust, driven by its indispensable role in surgical and critical care settings. Key trends and factors influencing the future outlook for suppliers include:

• Increasing Demand for Anesthesia: Global demographic shifts, including aging populations and rising rates of surgical procedures, will continue to drive demand for anesthetics like propofol.
• Focus on Drug Shortage Mitigation: Regulatory bodies and industry stakeholders are increasingly focused on ensuring a stable and resilient supply chain for critical medicines. This may lead to increased investment in domestic manufacturing capabilities and diversification of sourcing.
• Innovation in Formulations and Delivery: While propofol is a mature product, there remains an opportunity for innovation. Suppliers who can develop and patent improved formulations (e.g., reduced pain, enhanced stability, novel delivery systems) may gain a competitive edge.
• Sustainability in Manufacturing: Growing emphasis on environmental sustainability may encourage the development of greener manufacturing processes for propofol API and finished products.
• Competition from Alternative Anesthetics: While propofol is a dominant agent, the development of new anesthetic drugs or alternative sedation strategies could impact its market share over the long term, though significant disruption is not immediately foreseen.
• Consolidation and Strategic Partnerships: The pharmaceutical industry often sees consolidation. Further mergers or acquisitions among propofol suppliers could alter the competitive landscape. Strategic partnerships for R&D, manufacturing, or distribution are also likely.

The future outlook for propofol suppliers hinges on their ability to maintain high-quality manufacturing standards, navigate evolving patent landscapes, manage supply chain complexities, and respond to market demands for cost-effectiveness and product innovation.

Key Takeaways

• The propofol market is dominated by a limited number of large pharmaceutical manufacturers, including Fresenius Kabi, Hikma Pharmaceuticals, Teva, Baxter, and Cipla.
• While the propofol molecule is off-patent, intellectual property protection continues to exist around specific formulations, manufacturing processes, delivery systems, and novel therapeutic uses.
• Regulatory compliance, particularly concerning sterility and API purity, is paramount for propofol manufacturers, with strict oversight from agencies like the FDA and EMA.
• Propofol pricing is influenced by generic competition, manufacturing costs, and volume-based negotiations, with ongoing pressure to balance cost-effectiveness with supply security.
• Future market trends include increasing demand, a focus on supply chain resilience, potential for formulation innovation, and the ongoing impact of global regulatory and economic factors.

FAQs

1. Are there any new propofol formulations currently in late-stage development or awaiting regulatory approval? Recent patent filings and industry publications indicate ongoing research into improved propofol formulations, such as those aiming to reduce injection pain or enhance microbial stability. However, specific details on products in late-stage clinical trials or near regulatory submission are not publicly disclosed by all manufacturers. Interested parties should monitor regulatory agency approval databases and company pipeline updates.

2. What are the primary raw material challenges for propofol manufacturers? Key raw material challenges include ensuring a consistent supply of high-purity propofol API and pharmaceutical-grade excipients (e.g., soybean oil, glycerol). Fluctuations in the cost or availability of these components, driven by global supply chain disruptions or demand shifts, can impact production and pricing. Manufacturers often maintain multiple qualified suppliers to mitigate these risks.

3. How does the patent expiry of a propofol formulation impact pricing and market competition? Upon the expiry of a patent covering a specific propofol formulation, generic manufacturers can seek approval to market their own versions. This typically leads to increased market competition, a significant reduction in the price of the drug, and broader availability. The speed of market entry by generic competitors is a key factor influencing the extent of price erosion.

4. Can propofol be manufactured in countries with less stringent regulatory oversight, and what are the risks associated with such sources? While propofol can technically be manufactured in various locations, international markets typically require products to meet the GMP standards of the importing regulatory authority (e.g., FDA, EMA). Sourcing propofol from manufacturers in countries with less stringent regulatory oversight carries significant risks, including potential concerns regarding product quality, purity, sterility, and overall patient safety. It is crucial to verify a supplier's regulatory compliance and manufacturing standards.

5. What is the typical shelf life of a propofol emulsion, and how does formulation affect this? The typical shelf life for sterile propofol emulsions is generally between 12 to 36 months, depending on the specific formulation and packaging. Factors influencing shelf life include the stability of the emulsion, the effectiveness of any preservatives used, and the integrity of the container closure system. Innovations in formulation are often aimed at extending this shelf life while maintaining sterility and efficacy.

---

Citations

[1] Glen, J. B. (1983). Propofol Anesthesia. British Journal of Anaesthesia, 55(suppl 1), 103S-109S.