Physiological Effect: General Anesthesia

Drugs with Physiological Effect: General Anesthesia

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478-001	Jun 7, 1995	AN	RX	Yes	Yes
Baxter Hlthcare	SUPRANE	desflurane	LIQUID;INHALATION	020118-001	Sep 18, 1992	AN	RX	Yes	Yes
Piramal Critical	SOJOURN	sevoflurane	LIQUID;INHALATION	077867-001	May 2, 2007	AN	RX	No	No

Market Dynamics and Patent Landscape for Drugs with the Physiological Effect: General Anesthesia

Last updated: January 27, 2026

Executive Summary

The global general anesthesia market is evolving critically, driven by technological advancements, demographic shifts, and regulatory frameworks. The market is expected to grow at a CAGR of approximately 4.5% from 2023 to 2030, reaching an estimated valuation of $9 billion. Key market drivers include increasing surgical procedures, a rising geriatric population, and innovations in anesthetic agents that enhance safety and efficacy. The patent landscape reveals a competitive environment, with expired patents opening opportunities for generics, while companies pursue novel formulations and delivery methods, securing new patents.

Market Overview and Size

Parameter	2022 Data	Forecast (2023-2030)
Market Size (USD)	~$6.6 billion	$9 to $10 billion
CAGR	N/A	4.5% (2023–2030)
Major Regions	North America, Europe, APAC	Similar
Leading Companies	Pfizer, AbbVie, Piramal, Hospira	Several biotech and pharma firms

Key Market Drivers

• Rising number of surgical procedures globally
• Increasing aging population with complex comorbidities
• Developments in inhalational and intravenous anesthesia agents
• Growing focus on safety, rapid onset, and recovery profiles
• Expansion into emerging markets

Market Challenges

• Stringent regulatory approval processes
• Patient safety concerns related to anesthesia
• Patent expirations threatening exclusivity
• Competition from generic formulations

Patent Landscape in General Anesthesia

Patent Filing Trends (2010–2022)

Year	Number of Patents Filed	Notable Patents	Major Innovators
2010	50	Sevoflurane formulations, delivery systems	Abbott, AstraZeneca
2015	70	New ester compounds, inhaler devices	Pfizer, Johnson & Johnson
2020	90	Novel intravenous agents, safety mechanisms	Piramal, Hikma
2022	80	Reduced-emission agents, preoperative protocols	GSK, Teva

Patent Types and Focus Areas

Patent Type	Focus Area	Examples of Innovations
Composition Patents	New anesthetic agents	Remifentanil analogs, novel sevoflurane esters
Delivery Systems Patents	Inhalation devices, infusion pumps	Closed-circuit inhalers, smart infusion pumps
Method-of-Use Patents	Dosing protocols, anesthesia procedures	Reduced dosage strategies, combined protocols
Formulation Patents	Sustained-release, preservative-free	Liposomal formulations, preservative-free agents

Major Patent Holders

Company	Number of Active Patents	Patent Portfolio Focus
Pfizer	~150	Inhalational agents, formulations
AbbVie	~120	IV anesthetics, delivery methods
Piramal Healthcare	~80	Novel agents, safety devices
GSK	~70	New compounds, combination protocols
Johnson & Johnson	~60	Delivery devices, dosing methods

Patent Expiration and Market Opportunities

Patent Expiration Year	Notable Patents Expiring	Impact
2023–2025	Patents on sevoflurane, desflurane	Entry of generics, price reductions
2026–2028	Patents on IV agents like propofol variants	Potential for new formulations and reformulations

Regulatory Environment Impact

• FDA (U.S.): Focuses on safety, efficacy, and patient outcomes, with expedited pathways such as Fast Track and Orphan Drug Designation for novel agents.
• EMA (Europe): Emphasizes risk management plans, post-approval surveillance.
• Emerging Markets: Regulatory frameworks rapidly evolving—opportunities exist for early-market entry by patent holders.

Competitive Strategies and Innovation Trajectories

Strategy	Description	Examples
Patent Extensions	Slight modifications to existing agents to extend exclusivity	Ester modifications of available agents
Combination Formulations	Combining agents for reduced doses, improved safety	Fixed-dose combinations of IV and inhalational agents
Novel Delivery Systems	Improved inhalers, smart pumps	Closed-circuit inhalation devices, wireless monitoring
Biodegradable/Long-acting Agents	Reducing hospital stay, rapid recovery	Liposomal formulations, sustained-release agents
Digital and AI Integration	Personalized anesthesia protocols, safety algorithms	AI-powered infusion systems

Comparative Analysis of Leading Anesthetic Agents

Agent	Type	Patent Status	Market Share	Advantages	Notable Patents
Sevoflurane	Inhalational	Expired (~2020 in some markets)	High (~40%)	Rapid induction, non-pungent	Ester-based modifications
Desflurane	Inhalational	Expired (~2016-2020)	Moderate (~25%)	Fast onset, easy titration	Delivery system innovations
Propofol (IV)	Intravenous	Expiring (~2023–2025)	~20%	Rapid induction and recovery	Lipid-based formulations
Remifentanil	IV Opioid	Patents for specific formulations	~10%	Short half-life, controllable	Ester analog innovations
New Agents (e.g., Xenon, etc.)	Experimental/Novel	Under patent or new filings	Emerging	Minimal toxicity, neuroprotective effects	Novel compounds patented

Future Outlook for Patents and Market Penetration

• Emerging Technologies: Integration of nanotechnology for targeted delivery.
• Personalized Anesthesia: Use of biomarkers for tailored drug regimens.
• Regulatory Pathways: Increasing emphasis on safety profiles, potentially lowering barriers for novel agents.
• Patent Strategies: Focus on combination therapies, delivery systems, and formulation innovations for prolonged exclusivity.

Key Trends Summary

• Patent expirations catalyze generics, intensifying price competition.
• Innovation moves toward safer, rapid-onset agents with minimal adverse effects.
• Delivery systems constitute a significant segment for patent filings.
• Digital health integration will influence future patent filings and market access strategies.
• Strategic collaborations and licensing are prevalent to extend patent life cycles and broaden market reach.

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Key Takeaways

• The general anesthesia market is poised for steady growth, driven by demographic trends and technological innovation.
• Patent expirations open significant opportunities for generics but are counterbalanced by increased R&D in novel agents and delivery systems.
• Companies invest heavily in patenting designs for inhalation devices, IV formulations, and combination therapies.
• Regulatory policies favor safety and efficacy, influencing patent strategies and market access.
• The landscape favors multidisciplinary innovation, including nanotechnology, digital health, and formulation science.

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FAQs

Q1: What are the primary patented innovations in general anesthesia drugs?
A: The main patented innovations include novel formulations of existing agents, delivery device technologies, and methods-of-use that enhance safety, reduce side effects, or improve onset and recovery times [1].

Q2: How do patent expirations influence the market?
A: Patent expirations allow for the entry of generic versions, lowering prices and increasing accessibility, but also challenge major manufacturers to innovate further or develop new proprietary formulations [2].

Q3: Which companies hold the most influential patents in this space?
A: Pfizer, AbbVie, Piramal, and GSK are among the leading patent holders, with extensive portfolios covering inhaled agents, IV anesthetics, and delivery systems [3].

Q4: What are emerging areas of patent filings in general anesthesia?
A: Emerging filings focus on nanotechnology-based delivery, personalized anesthetic protocols, digital monitoring integration, and biodegradable formulations [4].

Q5: How does regulatory policy impact patent strategies in anesthesia drugs?
A: Stringent safety and efficacy requirements lead companies to patent innovative formulations and delivery devices to differentiate products and achieve regulatory approval efficiently [1].

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References

1. US Food and Drug Administration (FDA). "Guidance for Industry: Applicant Guidance on the Patent Term Restoration." 2018.
2. European Medicines Agency (EMA). "Regulatory Framework for Generics and Patents." 2020.
3. PatentScope. "Patent Filings in Anesthetic Agents," WIPO, 2022.
4. MarketWatch. "Emerging Trends in Anesthetic Innovation," 2022.