Suppliers and packagers for generic pharmaceutical drug: desflurane

desflurane

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Shanghai Hengrui	DESFLURANE	desflurane	LIQUID;INHALATION	208234	ANDA	Sandoz Inc.	0781-6172-86	6 BOTTLE, GLASS in 1 CARTON (0781-6172-86) / 240 mL in 1 BOTTLE, GLASS (0781-6172-22)	2018-02-26
Baxter Hlthcare	SUPRANE	desflurane	LIQUID;INHALATION	020118	NDA	Henry Schein, Inc.	0404-9961-25	1 BOTTLE in 1 BAG (0404-9961-25) / 240 mL in 1 BOTTLE	2022-01-12
Baxter Hlthcare	SUPRANE	desflurane	LIQUID;INHALATION	020118	NDA	Baxter Healthcare Corporation	10019-641-34	6 BOTTLE in 1 CARTON (10019-641-34) / 240 mL in 1 BOTTLE (10019-641-64)	1992-09-18
Baxter Hlthcare	SUPRANE	desflurane	LIQUID;INHALATION	020118	NDA	Baxter Healthcare Corporation	10019-644-34	6 BOTTLE in 1 CARTON (10019-644-34) / 240 mL in 1 BOTTLE (10019-644-64)	1992-09-18
Baxter Hlthcare	SUPRANE	desflurane	LIQUID;INHALATION	020118	NDA	Baxter Healthcare Corporation	10019-646-34	6 BOTTLE in 1 CARTON (10019-646-34) / 240 mL in 1 BOTTLE (10019-646-64)	1992-09-18

Desflurane Supplier Landscape and Patent Analysis

Last updated: February 19, 2026

This report analyzes the supplier landscape and patent protection for desflurane, a volatile anesthetic agent. Key manufacturers and their associated patents are identified, highlighting areas of ongoing innovation and potential market exclusivity.

Who Are the Primary Manufacturers of Desflurane?

The production and supply of desflurane are concentrated among a limited number of pharmaceutical companies. These entities hold the intellectual property and manufacturing capabilities required for its synthesis and formulation.

• Baxter Healthcare Corporation: A major supplier of desflurane. Baxter markets the product under the brand name Suprane.
• AbbVie Inc.: While not a direct manufacturer of desflurane itself, AbbVie is a significant player in the anesthetics market and may be involved in the distribution or formulation of desflurane-containing products through its subsidiaries or licensing agreements. AbbVie acquired Allergan, which had a presence in respiratory and anesthetics.
• General Pharmaceutical Companies: Various generic pharmaceutical manufacturers globally may produce desflurane, contingent on patent expiry and regulatory approvals in specific markets. However, primary brand-name supply is dominated by established players.

What is the Patent Landscape for Desflurane?

Patent protection is critical for recouping research and development costs and maintaining market exclusivity for pharmaceutical products. Desflurane has a history of patent filings related to its synthesis, purification, formulation, and novel delivery methods.

Key Patents and Their Focus

The foundational patents for desflurane's composition of matter have long expired. However, subsequent patents have been filed to protect improvements and specific aspects of its production and use.

• Synthesis Process Patents: Patents may cover specific chemical pathways, reagents, or conditions employed in the manufacturing of desflurane. For example, a patent might detail a more efficient or cost-effective method for achieving high purity.
  • Example of a patent focus: US Patent 5,859,275, filed in 1997 and granted in 1999, assigned to Baxter International Inc., describes methods for purifying fluorinated ethers, which would include desflurane. This patent is now expired but illustrates the type of innovation pursued.
• Formulation Patents: These patents protect specific compositions of desflurane, such as stabilized formulations or those designed for particular delivery devices.
• Delivery Device Patents: Innovations in the devices used to administer desflurane, such as vaporizers designed for precise concentration delivery, can also be patented.
• Polymorph Patents: While less common for volatile anesthetics, patents covering specific crystalline forms (polymorphs) can impact manufacturing and stability.
• Method of Use Patents: Patents may claim novel methods for using desflurane in specific clinical scenarios or in combination with other agents.

Current Patent Expirations and Future Projections

The primary composition-of-matter patents for desflurane have expired, allowing for the development of generic versions. However, the exclusivity of newer process, formulation, or method-of-use patents can still influence market dynamics.

• General Trend: Most patents directly related to the core desflurane molecule and its initial synthesis routes have expired.
• Ongoing Patenting Activity: Companies continue to seek patents for incremental improvements in manufacturing, stability, and delivery. These can extend market protection indirectly.
• Generic Entry: The expiry of key patents has opened the door for generic manufacturers, leading to increased price competition in markets where these generics are approved and available.

Who Holds Patents Related to Desflurane Production and Use?

Patent ownership is primarily concentrated among the original developers and major pharmaceutical manufacturers involved in anesthetics.

• Baxter Healthcare Corporation: As the primary brand-name marketer of Suprane, Baxter has been a significant patent holder for desflurane-related inventions. Its patent portfolio likely covers aspects of its manufacturing process, formulation, and potentially delivery devices.
• Research Institutions and Universities: Early research leading to the discovery and development of desflurane may have originated in academic settings, with patents licensed to pharmaceutical companies.
• Generic Manufacturers: As patents expire, generic companies will file their own patents for alternative synthesis routes or formulations if they develop novel, patentable aspects to their generic product.

What Are the Regulatory Considerations for Desflurane Suppliers?

Suppliers of desflurane must adhere to stringent regulatory requirements set by health authorities worldwide. These regulations ensure the safety, efficacy, and quality of the drug.

Key Regulatory Bodies and Requirements

• Food and Drug Administration (FDA) - United States: Manufacturers must obtain Abbreviated New Drug Application (ANDA) approval for generic desflurane. This requires demonstrating bioequivalence to the reference listed drug (Suprane) and meeting Current Good Manufacturing Practice (cGMP) standards.
• European Medicines Agency (EMA) - European Union: Similar to the FDA, the EMA requires Marketing Authorisation Applications (MAA) for generic desflurane, demonstrating quality, safety, and efficacy.
• Other National Regulatory Agencies: Health Canada, Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and others have their own approval processes.

Manufacturing and Quality Control Standards

• Good Manufacturing Practices (GMP): All manufacturing facilities must comply with cGMP regulations. This includes stringent controls over raw materials, production processes, quality testing, and documentation.
• Purity and Impurity Profiling: Desflurane must meet strict purity standards, with limits on specific impurities that could affect safety or efficacy. Analytical methods for detecting and quantifying impurities are critical.
• Stability Testing: Suppliers must conduct extensive stability studies to ensure the drug maintains its quality over its shelf life under recommended storage conditions.
• Environmental Controls: Volatile anesthetics require specific handling and storage due to their physical properties. Manufacturing environments must manage potential emissions and ensure worker safety.

How Does Patent Expiration Impact the Desflurane Market?

Patent expiration fundamentally alters the market dynamics for desflurane by enabling generic competition.

Impact on Pricing and Competition

• Price Erosion: The introduction of generic desflurane typically leads to significant price reductions due to increased competition. This can lower healthcare costs but reduce profit margins for the originator product.
• Increased Market Share for Generics: As generic versions become available and gain regulatory approval, they capture market share from the brand-name product.
• Supplier Diversification: Patent expiry allows new suppliers, primarily generic manufacturers, to enter the market, diversifying the supply chain.

Barriers to Generic Entry

Despite patent expiry, several factors can influence the speed and success of generic desflurane market entry:

• Regulatory Approval Timelines: Obtaining FDA (ANDA) or EMA (MAA) approval can be a lengthy and complex process, requiring substantial investment.
• Manufacturing Scale-Up: Generic manufacturers must establish robust, compliant manufacturing processes at a commercial scale.
• Intellectual Property Litigation: Originator companies may pursue patent litigation against generic entrants, alleging infringement of remaining patents (e.g., process or formulation patents), which can delay market entry.
• Supply Chain Establishment: Securing reliable sources of raw materials and establishing distribution networks are critical.

What Are the Future Trends in Desflurane Supply and Patenting?

The future of desflurane supply and patenting will be shaped by ongoing R&D, regulatory pressures, and evolving market demands.

Areas of Future Innovation and Patenting

• Greener Synthesis Routes: Development of more environmentally friendly manufacturing processes for desflurane, utilizing less hazardous reagents or reducing waste. Patents in this area could protect novel catalytic methods or solvent systems.
• Enhanced Delivery Systems: Innovations in anesthetic delivery devices, potentially incorporating smart technologies for monitoring patient response, improving precision, or reducing environmental release.
• Combination Therapies: Research into using desflurane in novel combinations with other anesthetic or analgesic agents, with patents potentially covering these specific synergistic combinations.
• Improved Stability and Shelf-Life: Development of new excipients or stabilization techniques to further enhance the long-term stability of desflurane formulations.
• Supply Chain Resilience: Patents or proprietary processes related to ensuring a more robust and secure global supply chain for desflurane, potentially addressing geopolitical or logistical risks.

Market Dynamics and Sustainability

• Competition with Alternatives: Desflurane faces competition from other volatile anesthetics (e.g., sevoflurane, isoflurane) and newer intravenous anesthetic agents. Patenting of superior alternatives or improved delivery methods could shift market share.
• Environmental Impact: Growing awareness of the greenhouse gas potential of volatile anesthetics, including desflurane, may drive innovation towards agents with lower global warming potential or improved capture/recycling technologies, potentially leading to new patentable inventions.
• Global Health Needs: Demand for essential medicines in developing countries will continue to drive the need for cost-effective desflurane, making process patents that enable lower-cost manufacturing valuable.

Key Takeaways

The desflurane market is characterized by a mature composition-of-matter patent landscape, allowing for generic entry. Baxter Healthcare Corporation is a primary brand-name supplier. While foundational patents have expired, ongoing patenting activity focuses on synthesis improvements, formulations, and delivery devices. Regulatory compliance with GMP is paramount for all suppliers. Future innovation and patenting are likely to target greener manufacturing, enhanced delivery, combination therapies, and supply chain resilience, while environmental impact considerations will increasingly influence market trends.

FAQs

1. What is the main patent protection for desflurane that has expired? The primary composition-of-matter patents for the desflurane molecule itself have expired.

2. Which company is the primary originator brand marketer of desflurane? Baxter Healthcare Corporation markets desflurane under the brand name Suprane.

3. Can generic desflurane be produced by any company after patent expiry? Generic desflurane can be produced by companies that obtain regulatory approval (e.g., ANDA from the FDA) and do not infringe on any remaining valid patents (e.g., process or formulation patents).

4. What are the key regulatory bodies that oversee desflurane production? Key regulatory bodies include the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

5. What areas are likely targets for future desflurane-related patenting? Future patenting is expected in areas such as greener synthesis routes, improved delivery systems, combination therapies, and enhanced formulation stability.

Citations

[1] U.S. Patent 5,859,275. (1999). Method for purifying fluorinated ethers. Baxter International Inc. [2] U.S. Food and Drug Administration. (n.d.). Abbreviated New Drug Applications (ANDAs). Retrieved from [FDA website] [3] European Medicines Agency. (n.d.). Marketing Authorisation Applications (MAA). Retrieved from [EMA website]