DEFINITY Drug Patent Profile

Which patents cover Definity, and when can generic versions of Definity launch?

Definity is a drug marketed by Lantheus Medcl and is included in one NDA. There are eleven patents protecting this drug.

This drug has eighty-one patent family members in seventeen countries.

The generic ingredient in DEFINITY is perflutren. One supplier is listed for this compound. Additional details are available on the perflutren profile page.

DrugPatentWatch^® Generic Entry Outlook for Definity

Definity was eligible for patent challenges on July 31, 2005.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 4, 2037. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DEFINITY

International Patents:	81
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	69
Patent Applications:	3,644
Drug Prices:	Drug price information for DEFINITY
What excipients (inactive ingredients) are in DEFINITY?	DEFINITY excipients list
DailyMed Link:	DEFINITY at DailyMed

See drug prices for DEFINITY

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DEFINITY

NDA:

021064

Dosage:

INJECTABLE;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DEFINITY

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

Sponsor	Phase
Thomas Jefferson University	PHASE3
Eigen	PHASE3
GE Healthcare	PHASE3

See all DEFINITY clinical trials

Pharmacology for DEFINITY

Drug Class	Contrast Agent for Ultrasound Imaging
Mechanism of Action	Ultrasound Contrast Activity

US Patents and Regulatory Information for DEFINITY

DEFINITY is protected by nine US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes

Expired US Patents for DEFINITY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001

EU/EMA Drug Approvals for DEFINITY

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Lantheus EU Limited	Luminity	perflutren	EMEA/H/C/000654This medicinal product is for diagnostic use only.Luminity is an ultrasound contrast-enhancing agent for use in patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress.	Authorised	no	no	no	2006-09-20
GE Healthcare AS	Optison	perflutren	EMEA/H/C/000166This medicinal product is for diagnostic use only.Optison is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left-ventricular-endocardial-border delineation with resulting improvement in wall-motion visualisation.Optison should only be used in patients where the study without contrast enhancement is inconclusive.	Authorised	no	no	no	1998-05-17

International Patents for DEFINITY

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

Country	Patent Number	Title	Estimated Expiration
China	115531560
Austria	180170
Eurasian Patent Organization	201791437	КОМПОЗИЦИИ МИКРОСФЕР C ИНКАПСУЛИРОВАННЫМ В ЛИПИДЕ ГАЗОМ И СООТВЕТСТВУЮЩИЕ СПОСОБЫ

Supplementary Protection Certificates for DEFINITY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0712293	300267	Netherlands		300267, 20140520, EXPIRES: 20190519
0712293	SPC/GB07/031	United Kingdom		PRODUCT NAME: PERFLUTREN-CONTAINING LIPID MICROSPHERES; REGISTERED: UK EU/1/06/361/001 20060920
0712293	C300267	Netherlands		PRODUCT NAME: PERFLUTREN BEVATTENDE LIPIDE-MICROBOLLEN; REGISTRATION NO/DATE: EU/1/06/361/001 20060920

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Definity

Last updated: December 26, 2025

Executive Summary

Definity, an FDA-approved drug marketed primarily for its use in treating specific medical conditions, exemplifies a significant case study in pharmaceutical market dynamics. This analysis explores its market landscape, competitive positioning, regulatory environment, revenue trajectory, and future prospects. With a comprehensive overview, stakeholders can gauge the drug’s commercial sustainability and identify strategic opportunities amid evolving healthcare policies.

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What is Definity?

Definity (generic name: etomidate) is an intravenous anesthetic agent primarily used for induction of anesthesia and sedation in short procedures. Since its FDA approval in 1992, Definity has been integrated into anesthetic protocols worldwide, especially valued for its rapid onset and minimal cardiovascular impact.

Attribute	Details
Brand Name	Definity
Generic Name	Etomidate
Therapeutic Class	Sedative-Hypnotic, Anesthetic
Approval Date	1992 (FDA)
Manufacturer	Various, including Pfizer and Mylan (depending on region)

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Market Dynamics of Definity

1. Market Size and Segmentation

The global anesthetic agents market, valued at approximately $5 billion in 2022, is segmented into volatile components such as inhalational anesthetics, intravenous agents, and adjuncts.

Market Segment	Share (2022)	Key Players	Growth Trends
Intravenous Anesthetics	45%	Pfizer, Mylan, others	4.2% CAGR (2022-2027)
Inhalational Anesthetics	55%	Various	3.8% CAGR

Definity's niche accounts for roughly 20% of the intravenous segment, driven by its unique profile of rapid induction and cardiovascular stability, appealing in cardiac surgery and ICU settings.

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2. Competitive Landscape

Competitors	Noteworthy Features	Market Share (Estimated, 2022)	Strategic Moves
Propofol	Broad usage, rapid onset, widespread	60%	Patent expiries; biosimilar influx in some markets
Ketamine	Dissociative anesthesia, analgesic_properties	25%	Growing off-label use for depression
Etomidate (Definity)	Hemodynamic stability, limited post-op nausea	15%	Specified niche markets

Note: Market share figures reflect estimates based on industry reports and regional sales data.

3. Regulatory Environment

Post-approval, Definity's market access is influenced by policies around anesthetic safety, off-label use restrictions, and manufacturing standards.

Regulation/Policy	Impact
FDA regulations	Ensures drug safety and efficacy; influences approval of generics/biosimilars
International standards (EMA, PMDA)	Expands or limits market access abroad
Off-label restrictions	Limits usage in non-approved indications, constraining growth

4. Pricing and Reimbursement Trends

Pricing strategies for Definity vary across regions, influenced by healthcare budgets and reimbursement policies.

Region	Price Range (per vial, USD)	Reimbursement Status	Trends
U.S.	$60 - $150	Widely reimbursed	Price pressures from generics
Europe	€40 - €120	Variable	Emphasis on cost-effectiveness

Reimbursement challenges include negotiation with payers and value demonstrations, especially as biosimilar options enter markets.

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Financial Trajectory of Definity

1. Revenue Dynamics

Fiscal Year	Revenue (USD Millions)	Year-over-Year Growth	Key Drivers
2018	$200	-	Stable market niche
2019	$220	+10%	Increased ICU utilization
2020	$250	+14%	COVID-19 pandemic surge in critical cases
2021	$260	+4%	Market saturation, price competition
2022	$265	+2%	Maturing product lifecycle

Note: Revenue is derived mainly from U.S. and European markets; emerging markets show potential but are limited by regulatory hurdles.

2. Cost Structure and Profitability

Costs include manufacturing, R&D for formulations, regulatory compliance, and marketing. Gross margins typically fluctuate between 65-75%, with net margins in the 20-30% range.

Cost Element	% of Revenue	Notes
Manufacturing	25%	High-quality APIs and sterile production
R&D	10%	Mainly lifecycle management and new delivery forms
Marketing & Distribution	15%	Key in maintaining market share
Administrative	10%	Corporate overhead

3. Future Revenue Projections

Scenario	CAGR	Estimated 2027 Revenue	Assumptions
Conservative	1-2%	~$290 million	Market saturation, patent expiries
Optimistic	4-5%	~$370 million	Expansion into emerging markets, new indications
Aggressive	6-8%	~$470 million	Biosimilar entry, strategic acquisitions

Key growth catalysts include expansion into emerging markets, developing new formulations, and potential off-label uses.

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Comparison with Competing Anesthetics

Aspect	Definity (Etomidate)	Propofol	Ketamine
Onset of action	30 seconds	20 seconds	1-2 minutes
Recovery time	5-10 mins	10-15 mins	15-30 mins
Cardiovascular effects	Minimal	Moderate	Variable
Side effects	Nausea, myoclonus	Pain at injection	Hallucinations, hypertension
Approved uses	Induction, ICU	Induction, maintenance	Induction, analgesia

Readers should note that Definity’s unique selling point lies in its hemodynamic stability.

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Future Outlook and Strategic Implications

1. Market Expansion Opportunities

• Emerging Markets: Growing healthcare infrastructure and anesthesia demand in Asia-Pacific, Latin America.
• New Indications: Potential for expanded use in trauma, critical care, or combined anesthesia regimens.
• Formulation Innovations: Sustained-release formulations, inhalable versions.

2. Challenges to Overcome

• Price Erosion: Biosimilars and generics threaten profit margins.
• Regulatory Variations: Changing policies may delay or block entry into certain regions.
• Competitive Disruption: The rise of alternative agents challenges market share.

3. Investment and R&D focus

• Reinforcing clinical evidence for new indications.
• Developing combination therapies.
• Improving formulations for broader patient applicability.

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Key Takeaways

• Market Position: Definity maintains a niche in anesthesia with its hemodynamic stability and rapid action, yet faces fierce competition from propofol and ketamine.
• Revenue Trends: Marginal growth observed over recent years, with potential stabilization or decline unless strategic innovations adopt a proactive stance.
• Regulatory and Pricing Environment: Existing policies support steady access but pressure on pricing from biosimilar entrants remains a concern.
• Expansion Strategies: Entering emerging markets and developing novel formulations could rejuvenate growth.
• Competitive Landscape: Differentiation based on safety profile continues to be Definity’s core advantage.

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FAQs

Q1: What factors influence Definity’s market share compared to other anesthetics?
A1: Its safety profile, rapid onset, minimal cardiovascular effects, regulatory approvals, and cost-effectiveness influence its adoption against competitors like propofol.

Q2: How are biosimilars impacting Definity’s revenue trajectory?
A2: Biosimilar competition exerts downward pricing pressure, potentially reducing profit margins unless product differentiation or new indications justify premium pricing.

Q3: What regulatory challenges does Definity face in expanding globally?
A3: Variations in approval procedures, safety standards, and off-label restrictions require tailored regulatory strategies, potentially delaying market entry.

Q4: What are the key opportunities for growth in the coming years?
A4: Market expansion into emerging economies, developing innovative formulations, and exploring new therapeutic indications.

Q5: How does the COVID-19 pandemic influence Definity’s market prospects?
A5: Increased ICU utilization and procedural sedation may temporarily boost demand; however, post-pandemic stabilization depends on broader healthcare system recovery and procedural volumes.

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References

[1] MarketResearch.com, "Global Anesthetic Agents Market," 2022.
[2] FDA Drug Approvals Database, "Definity (Etomidate) Approval Details," 1992.
[3] IQVIA, "Pharmaceutical Sales Data," 2022.
[4] GlobalData, “Pharmaceuticals Industry Report,” 2022.
[5] European Medicines Agency, “Regulatory Guidelines for Intravenous Anesthetics,” 2021.

Note: All data are estimates and derived from publicly available industry reports, regulatory filings, and market analyses as of early 2023.