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. Ten 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
National Institute of General Medical Sciences (NIGMS)	Phase 1
Keith M. Vogt, MD, PhD	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	5,990,176*PED
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478-001	Jun 7, 1995	6,074,668*PED
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478-001	Jun 7, 1995	6,444,859*PED
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478-001	Jun 7, 1995	6,288,127*PED

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	2000510159
China	1560003
Peru	08402000
Portugal	1114641

ULTANE: Patent Landscape and Commercial Outlook

Last updated: February 19, 2026

ULTANE (sevoflurane) has maintained a significant position in the anesthetic market due to its established safety profile and pharmacokinetic properties. This analysis examines ULTANE's patent landscape, market penetration, and financial performance, highlighting key intellectual property considerations and future commercial prospects.

What is ULTANE's Current Market Position?

ULTANE, marketed by AbbVie (formerly Abbott Laboratories), is a volatile anesthetic used for inhalation induction and maintenance of general anesthesia in adult and pediatric patients. Its primary market is the hospital setting, specifically operating rooms and intensive care units.

Market Share and Competition

ULTANE competes with other volatile anesthetics such as isoflurane, desflurane, and sevoflurane generics. While specific real-time market share data is proprietary, ULTANE has historically held a substantial segment of the inhaled anesthetic market in developed economies. The introduction of sevoflurane generics has, however, led to price erosion and a gradual decline in ULTANE's market share in recent years. Desflurane (Suprane) remains a key competitor, particularly for rapid emergence, while isoflurane serves as a lower-cost alternative.

Therapeutic Advantages and Limitations

ULTANE's advantages include rapid induction and emergence, low pungency (facilitating mask induction), and a favorable cardiovascular and respiratory profile compared to some older agents. Its limitations include potential for renal toxicity if exposed to soda lime with desiccated carbon dioxide absorbents, and a relatively higher cost compared to generic sevoflurane and isoflurane. Environmental concerns regarding the greenhouse gas potential of sevoflurane also represent a growing consideration.

What is ULTANE's Patent Status?

The patent landscape for ULTANE is characterized by expired primary patents covering the active pharmaceutical ingredient (API) and its basic uses. This has paved the way for generic competition.

Key Patents and Expiration Dates

The foundational patents for sevoflurane, including its chemical synthesis and use as an inhalation anesthetic, have expired.

• Original Composition of Matter Patent: The earliest patents for sevoflurane have long expired. For example, U.S. Patent 3,531,546, filed in 1967 and granted in 1970, covered fluorinated ethers, which would have encompassed sevoflurane. [1]
• Method of Use Patents: Patents related to specific anesthetic administration methods or patient populations also faced expiration.
• Evergreening Efforts: While direct patent challenges to the core API are no longer relevant, pharmaceutical companies often pursue secondary patents related to specific formulations, manufacturing processes, or novel delivery systems. Information on such secondary patents specific to AbbVie's branded ULTANE product is not readily available in public databases for ongoing litigation.

The expiration of core patents has been the primary driver for the entry of generic sevoflurane products.

What is ULTANE's Financial Performance?

AbbVie's financial reporting does not typically break out sales for individual legacy products like ULTANE in granular detail, especially following the divestment of certain pharmaceutical portfolios. However, its performance can be inferred from broader anesthetic market trends and AbbVie's historical reporting.

Revenue Trends and Impact of Generics

Prior to widespread generic entry, ULTANE contributed significantly to Abbott Laboratories' pharmaceutical division revenue. Post-patent expiration, sales have predictably declined due to price competition from generics.

• Pre-Generic Era: In the years leading up to and shortly after patent expiries, ULTANE represented a substantial revenue stream within the anesthesia segment. For instance, in the mid-2000s, sevoflurane (including branded ULTANE) was a multi-hundred-million-dollar product category for Abbott.
• Post-Generic Era: Since the introduction of generic sevoflurane products, the market has become more price-sensitive. This has shifted revenue from branded manufacturers like AbbVie to generic manufacturers. AbbVie continues to market ULTANE, but its revenue contribution from this product is considerably lower than in its patent-protected period. Precise current revenue figures for ULTANE are not publicly disclosed.

Profitability Considerations

The profitability of ULTANE for AbbVie is influenced by several factors:

• Manufacturing Costs: As a mature product, manufacturing processes are likely optimized, contributing to potentially stable cost of goods sold.
• Marketing and Sales Expenses: Reduced marketing spend is expected for a product facing significant generic competition.
• Pricing Power: The brand premium for ULTANE has diminished due to generic alternatives, impacting profit margins.
• Generic Competition: The presence of multiple generic manufacturers intensifies price competition, directly impacting revenue and profitability per unit.

What are the Future Market Dynamics for ULTANE?

The future market for ULTANE is characterized by continued reliance on its established use profile, offset by the ongoing impact of generic competition and evolving anesthetic practices.

Generics and Market Saturation

The market for sevoflurane is largely saturated with generic options. This trend is expected to continue, with price remaining a primary differentiator. Branded ULTANE will likely maintain a niche for specific clinical settings or physician preferences where brand loyalty or perceived quality assurance outweighs cost savings.

Emerging Anesthetic Technologies

While ULTANE is a mature product, research into newer anesthetic agents and delivery methods continues.

• Ultra-low Flow Anesthesia: Techniques that minimize fresh gas flow can reduce anesthetic agent consumption and cost. This indirectly impacts the market share of all volatile agents, including ULTANE.
• Regional Anesthesia and Sedation: Advancements in regional anesthetic techniques and sedation protocols can reduce the reliance on general anesthesia in certain surgical procedures, impacting the overall demand for volatile agents.
• Environmental Impact: Growing awareness and regulatory pressures concerning the environmental impact of greenhouse gases, including sevoflurane, may influence prescriber choices. Newer agents with lower global warming potential are being explored.

Market Segmentation and Geographic Considerations

• Developed Markets: In North America and Western Europe, the market is dominated by generic sevoflurane. ULTANE's presence is sustained by hospital formularies and physician familiarity.
• Emerging Markets: In developing economies, price sensitivity is higher, making generic sevoflurane the dominant choice. ULTANE's adoption in these regions may be slower or limited to higher-tier healthcare facilities.

Key Takeaways

• ULTANE's foundational patents have expired, leading to significant generic competition and a decline in its market share and revenue contribution to AbbVie.
• The anesthetic market for sevoflurane is mature and highly price-sensitive, with generic products now dominating.
• AbbVie continues to market branded ULTANE, likely targeting specific segments or physician preferences, but its market position is primarily as a mature, branded option within a largely genericized field.
• Future market dynamics will be shaped by continued generic pricing pressure, evolving anesthetic practices, and growing considerations for environmental impact.

Frequently Asked Questions

1. What is the primary indication for ULTANE? ULTANE is indicated for the induction and maintenance of general anesthesia in adult and pediatric patients.

2. Who is the current manufacturer of ULTANE? AbbVie, following its acquisition of Abbott Laboratories' research-based pharmaceuticals business, is the manufacturer of ULTANE.

3. Are there any significant clinical trials ongoing for ULTANE? As a mature product with expired core patents, large-scale clinical trials for ULTANE are unlikely. Research may focus on specific niche applications or comparative studies against newer agents.

4. What is the environmental impact of ULTANE (sevoflurane)? Sevoflurane is considered a greenhouse gas, contributing to global warming. Its global warming potential (GWP) is a factor in its environmental assessment compared to other anesthetics.

5. What is the typical price difference between branded ULTANE and generic sevoflurane? The price difference can vary significantly based on region, supplier, and volume of purchase, but generic sevoflurane is consistently priced lower than branded ULTANE.

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[1] U.S. Patent 3,531,546. (1970). Fluorinated ethers. Retrieved from USPTO Patent Database.