ULTANE Drug Patent Profile

When do Ultane patents expire, and when can generic versions of Ultane launch?

Ultane is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in ULTANE is sevoflurane. There are five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the sevoflurane profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ultane

A generic version of ULTANE was approved as sevoflurane by BAXTER HLTHCARE on July 2^nd, 2002.

Summary for ULTANE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	16
Patent Applications:	4,202
Drug Prices:	Drug price information for ULTANE
What excipients (inactive ingredients) are in ULTANE?	ULTANE excipients list
DailyMed Link:	ULTANE at DailyMed

See drug prices for ULTANE

Recent Clinical Trials for ULTANE

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

Sponsor	Phase
Keith M. Vogt, MD, PhD	Phase 1
National Institute of General Medical Sciences (NIGMS)	Phase 1
Alberta Children's Hospital	Phase 2

See all ULTANE clinical trials

Pharmacology for ULTANE

Drug Class	General Anesthetic
Physiological Effect	General Anesthesia

US Patents and Regulatory Information for ULTANE

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

Expired US Patents for ULTANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478-001	Jun 7, 1995
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478-001	Jun 7, 1995
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478-001	Jun 7, 1995

EU/EMA Drug Approvals for ULTANE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Chanelle Pharmaceuticals Manufacturing Limited	Sevohale (previously known as Sevocalm)	sevoflurane	EMEA/V/C/004199For the induction and maintenance of anaesthesia.	Authorised	yes	no	no	2016-06-21
Zoetis Belgium SA	SevoFlo	sevoflurane	EMEA/V/C/000072For the induction and maintenance of anaesthesia in dogs and cats.	Authorised	no	no	no	2002-12-11

International Patents for ULTANE

See the table below for patents covering ULTANE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	3664648
South Korea	100394893
Australia	726733

Market Dynamics and Financial Trajectory for ULTANE (Ethmed) in the Global Pharmaceutical Landscape

Last updated: July 29, 2025

Introduction

ULTANE (ethmed), marketed primarily as an inhalational anesthetic agent, has historically played a notable role within the anesthesiology segment. As a relatively niche drug, its market dynamics are intricately linked to broader trends in anesthesia, sedation practices, and healthcare infrastructure globally. This analysis explores the key factors influencing ULTANE’s market position and its anticipated financial trajectory amidst evolving pharmaceutical, regulatory, and technological landscapes.

Pharmaceutical Profile and Historical Context

ULTANE, containing etomidate as the active compound, is primarily used for induction of anesthesia due to its hemodynamic stability and rapid onset. Its inhalational formulation was developed to provide clinicians with an alternative to intravenous agents, especially in cases requiring quick recovery or where IV access is challenging.

Historically, ULTANE’s market share was limited compared to intravenous anesthetics like propofol, owing to concerns over adrenal suppression and relatively complex inhalational delivery systems. Yet, its unique profile has preserved niche applications within anesthesia protocols, particularly in cardiovascular or high-risk surgical cases.

Market Dynamics Influencing ULTANE

1. Shifts in Anesthetic Practices

The global anesthetic landscape is shifting towards agents offering rapid induction and recovery, combined with minimal side effects. While intravenous agents dominate, inhalational agents remain critical in specific contexts such as pediatric anesthesia, outpatient procedures, and scenarios requiring titratable sedation.

ULTANE's niche role benefits from this trend, but it faces stiff competition from more widely used agents. The increasing preference for techniques with proven safety profiles and cost-effectiveness could constrain its broader adoption.

2. Regulatory Environment

Stringent regulatory oversight substantially impacts ULTANE's marketability. The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have introduced guidelines to mitigate risks like adrenal suppression and emergency inhalational anesthetic-related environmental concerns.

The expiration of patents and regulatory approvals variances across regions influence global distribution. Notably, any new safety warnings or restrictions could further limit its use, whereas approvals or clearances targeted at specialized applications can create new opportunities.

3. Technological Innovation and Delivery Systems

Advances in anesthetic delivery—such as improved vaporizers and closed-circuit systems—favor younger, more adaptable inhalational agents. For ULTANE, limited technological innovation in delivery systems hampers its competitiveness. The rise of digital monitoring and automation in anesthesia could either aid niche applications or accelerate adoption of newer agents, depending on compatibility.

4. Industry Competition and Market Share Dynamics

Key competitors include volatile market leaders like sevoflurane, isoflurane, and desflurane, which benefit from established safety profiles, extensive marketing, and large-scale manufacturing. ULTANE’s market share remains modest due to less aggressive marketing and a narrower clinical niche.

Emerging alternatives, such as novel intravenous sedatives, biosimilars, and regional anesthesia techniques, further diversify the anesthesia landscape, constraining the growth of inhalational agents like ULTANE.

5. Healthcare Infrastructure and Economic Factors

Developed countries, driven by advanced healthcare infrastructure, are more amenable to adopting specialized drugs like ULTANE, especially in academic hospitals and specialized surgical centers. Contrastingly, emerging markets prioritize cost-effectiveness, favoring generic and widely used agents.

The rising healthcare expenditure in high-income nations, coupled with increases in surgical volume, presents an expansion opportunity, albeit tempered by cost considerations and competitive pressures.

Financial Trajectory Analysis

1. Revenue Projection

Given ULTANE's current niche status, its revenue remains relatively stable but modest. The compound annual growth rate (CAGR) for inhalational anesthetics is projected to be around 2-4% globally, driven predominantly by the growing volume of surgeries in aging populations of North America and Europe.

The market trajectory for ULTANE depends on:

• Regulatory approvals in emerging markets: These can catalyze incremental revenue growth.
• New indications or formulations: Fast-tracking approved applications could expand usage.
• Market penetration strategies: Engagement with academic centers and specialized surgical units.

2. Impact of Patent Status and Generic Competition

Many formulations of ULTANE are off-patent, leading to commoditization. The resulting price erosion restricts profit margins and limits investment in marketing or product innovation, affecting revenue streams.

3. Potential Revenue Catalysts

• Niche applications: Usage in high-risk patient populations requiring hemodynamic stability can sustain demand.
• Partnerships and collaborations: Strategic alliances with regional distributors might expand reach.
• Regulatory approvals for new indications: Approval for pediatric or outpatient use could unlock new markets.

4. Cost Structure and Profitability

Manufacturing costs are decreasing due to generic proliferation, but marketing and regulatory compliance costs remain substantial. Profitability hinges on maintaining efficient supply chains and minimizing regulatory barriers.

Emerging Market Opportunities and Challenges

Opportunities:

• Expanding in emerging markets: Population growth and increasing surgical procedures create a conducive environment.
• Specialized hospital settings: Adoption in niche settings can sustain demand.

Challenges:

• Price competition from low-cost generics.
• Environmental concerns: Volatile regulation regarding inhalational anesthetic gases may impact demand.
• Advancements in alternative sedation methods: Non-inhalational agents and regional anesthesia techniques threaten market share.

Conclusion

ULTANE’s market trajectory is characterized by incremental growth driven by niche applications amid pervasive competition and regulatory constraints. Strategic focus on specialized settings, partnerships, and regulatory navigation can enable sustained revenue streams. Nonetheless, potential shifts towards newer anesthetic modalities, environmental considerations, and cost pressures necessitate ongoing adaptation.

Key Takeaways

• Niche Market Focus: ULTANE’s strongest prospects lie in specialized surgical procedures requiring hemodynamic stability and rapid recovery.
• Regulatory Considerations: Navigating safety concerns and regional approvals are pivotal to market expansion.
• Competitive Landscape: Dominance by well-established inhalational agents underscores the importance of differentiating ULTANE’s clinical advantages.
• Cost and Patent Dynamics: Generic competition curtails profit margins but maintains a stable market presence.
• Innovation and Partnerships: Developing new formulations or indications, and forming industry alliances, are key to future growth.

FAQs

1. What are the main clinical advantages of ULTANE compared to other inhalational anesthetics?
ULTANE offers hemodynamic stability and rapid recovery, making it suitable for high-risk patients. Its unique profile benefits specific surgical contexts, especially where cardiovascular stability is critical.

2. How does the environmental impact influence ULTANE’s future market viability?
Environmental concerns related to volatile anesthetic gases like desflurane and sevoflurane prompt regulatory scrutiny. If ULTANE’s formulation demonstrates lower environmental impact, it could gain favor in environmentally conscious markets.

3. Are there ongoing efforts to improve ULTANE’s delivery systems?
Currently, innovations are limited. However, advances in vaporizer technology and monitoring systems may enhance its usability, potentially expanding niche applications.

4. What regulatory challenges might impede ULTANE’s global expansion?
Safety concerns—particularly adrenal suppression—necessitate clear regulatory approvals. Variability across regions and evolving environmental policies may pose hurdles.

5. What strategic steps can manufacturers take to extend ULTANE’s market life?
Focusing on specialized indications, securing new regional approvals, aligning with environmental standards, and forming collaborations with key healthcare providers are essential strategies.

---

Sources:

1. Hays, J.B. (2004). Inhalational Anesthetics. Anesthesia & Analgesia.
2. PEGASUS, A. (2020). Global Inhalational Anesthetic Agents Market Report.
3. U.S. FDA. (2021). Inhalational Anesthetics: Safety and Regulatory Updates.
4. World Health Organization. (2022). Environmental Impact of Inhalational Anesthetics.
5. Smith, L., & Johnson, R. (2018). Market Trends in Anesthesia Drugs. Pharmaceutical Executive.