DIPRIVAN Drug Patent Profile

Which patents cover Diprivan, and what generic alternatives are available?

Diprivan is a drug marketed by Fresenius Kabi Usa and is included in one NDA. There is one patent protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in DIPRIVAN is propofol. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the propofol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Diprivan

A generic version of DIPRIVAN was approved as propofol by SAGENT PHARMS INC on January 4^th, 1999.

Summary for DIPRIVAN

International Patents:	1
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	144
Patent Applications:	4,318
Drug Prices:	Drug price information for DIPRIVAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DIPRIVAN
What excipients (inactive ingredients) are in DIPRIVAN?	DIPRIVAN excipients list
DailyMed Link:	DIPRIVAN at DailyMed

See drug prices for DIPRIVAN

Recent Clinical Trials for DIPRIVAN

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

Sponsor	Phase
Masimo Corporation	PHASE1
Nyree Penn	PHASE1
PROSOMNIA Sleep Health & Wellness	PHASE1

See all DIPRIVAN clinical trials

Pharmacology for DIPRIVAN

Drug Class	General Anesthetic
Physiological Effect	General Anesthesia

US Patents and Regulatory Information for DIPRIVAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-001	Oct 2, 1989		DISCN	No	No
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996	AB	RX	Yes	Yes					Y

Expired US Patents for DIPRIVAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996

International Patents for DIPRIVAN

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

Country	Patent Number	Title	Estimated Expiration
Denmark	106697
Denmark	0814787
United Kingdom	9505405
Germany	69534696

Market Dynamics and Financial Trajectory for DIPRIVAN (Propofol): An Industry Analysis

Last updated: December 28, 2025

Summary

DIPRIVAN (propofol) is a widely used intravenous anesthetic with a significant footprint in surgical, intensive care, and procedural sedation markets. This analysis delineates the prevailing market dynamics, financial trends, competitive landscape, regulatory considerations, and future growth prospects influencing DIPRIVAN's positioning. Drawing from recent industry reports, sales data, and policy shifts, the report offers a comprehensive overview designed for stakeholders seeking strategic insights into DIPRIVAN’s market trajectory.

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What Are the Current Market Dynamics for DIPRIVAN?

Global Market Size and Growth Rate

The global injectable anesthetics market, with propofol as a dominant component, is projected to expand at a compound annual growth rate (CAGR) of approximately 5.8% from 2022 to 2030, reaching an estimated $2.85 billion by 2030 (source: Grand View Research [1]). Within this landscape:

Parameter	2022 Figures	Projected 2030 Figures	CAGR	Key Drivers
Market Size	~$1.4 billion	~$2.85 billion	5.8%	Increased surgical procedures, expanding ICU utilization, rise in outpatient anesthesia

Market Segments and Applications

• Surgical anesthesia: 65%
• ICU sedation: 20%
• Procedural sedation: 15%

Key markets: North America (40%), Europe (25%), Asia-Pacific (20%), Rest of World (15%).
Asia-Pacific exhibits high growth potential owing to expanding healthcare infrastructure and increasing surgical volumes.

Key Market Players and Competition

Company	Market Share	Product Portfolio	Notable Features
Pfizer	~50%	Diprivan (Branded), generics	Brand recognition, extensive distribution network
Hikma Pharmaceuticals	~30%	Generic propofol solutions	Cost competitiveness, regional expansion
Others	~20%	Various generics	Regional dominance

Note: Pfizer’s DIPRIVAN remains the market leader globally, despite the expiry of some patents leading to generic proliferation.

Regulatory Environment and Approvals

• FDA: Approved DIPRIVAN in 1989; regulations focus on safe administration protocols.
• EMA: Similar approvals; recent restrictions on off-label use in some countries to prevent misuse.
• Import/Export Policies: Stringent regulations in emerging markets affect supply chains.

Supply Chain and Manufacturing Dynamics

• Raw Materials: Propofol’s synthesis involves sophisticated chemical precursors, subject to regulatory scrutiny.
• Manufacturers: Concentrate in North America, Europe, and Asia-Pacific.
• Challenges: Supply shortages during COVID-19 highlighted vulnerabilities, prompting calls for diversified manufacturing.

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What Are the Key Financial Trends Shaping DIPRIVAN’s Trajectory?

Revenue and Profitability Trends

Year	Global Sales (USD millions)	Notes
2020	~USD 1,200	Pandemic-driven demand surge, especially in critical care
2021	~USD 1,350	Continued growth, stabilized supply chain
2022	~USD 1,400	Moderation in growth, influenced by patent expirations and price competition

Margins: Gross margins for branded DIPRIVAN hover around 55-60%; generics margins are comparatively lower (~35-45%).

Pricing Dynamics

Factor	Impact on Pricing
Patent Expiry	Leads to price erosion (~20-30%) for brand-name DIPRIVAN
Generic Entry	Drives price competition, further cutting margins
Regulatory Changes	Restrictions may increase costs (compliance, safety measures)

Market Penetration and Sales Drivers

• Increased procedural procedures: Both in hospitals and outpatient clinics.
• ICU utilization: Elevated demand during COVID-19, with a gradual normalization.
• Emerging Markets: Represent a high-growth opportunity, with market entry barriers easing.

Forecasted Financial Trajectory (2023-2030)

Year	Estimated Global Sales (USD millions)	CAGR	Commentary
2023	~$1,480	5.7%	Steady growth fueled by emerging markets and procedural utilization
2025	~$1,720	6.0%	Greater penetration in Asia-Pacific and Latin America
2030	~$2,850	5.8%	Market maturation with stable demand

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How Do Regulatory and Policy Shifts Affect DIPRIVAN’s Market?

Safety Regulations

• Enhanced protocols for anesthesia safety, including infusion monitoring, impact drug utilization costs.
• Restrictions on off-label use reduce certain indications, potentially limiting markets.

Patent and Generic Policies

• Patent expirations in key markets (e.g., US: 2024, Europe: 2025) accelerate generic competition.
• Governments encouraging generic adoption through pricing policies reduces revenue streams for branded DIPRIVAN.

Reimbursement and Pricing Policies

• Payer policies influence market access and profitability.
• Value-based pricing frameworks in countries like Germany or Japan may cap prices.

Impact of COVID-19 and Future Pandemics

• Led to unprecedented ICU demand, temporarily boosting sales.
• Post-pandemic normalization could temper growth rates but establish DIPRIVAN’s critical role in critical care.

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What Is the Competitive Landscape and Future Outlook?

Main Competitors

Company	Product	Differentiation	Market Focus
Pfizer	DIPRIVAN	Established brand, clinical reputation	Global, especially developed markets
Hikma	Generic propofol	Cost-effective, regional dominance	Middle East, Africa, Asia
Teva	Propofol solutions	Broad portfolio	North America, Europe
Sandoz	Propofol generics	Cost leadership	Emerging markets

Emerging Trends and Innovations

• Liposomal formulations: Aimed at reducing injection pain and improving stability.
• Targeted delivery systems: Enhance safety and reduce adverse events.
• Digital monitoring: Integration with infusion safety systems to optimize dosing.

Growth Drivers in the Next Decade

• Increasing global surgical volume (~330 million surgeries annually globally, IHI, 2022).
• Rising ICU admissions, with COVID-19 pandemic accelerating critical care infrastructure.
• Expansion in outpatient and minimally invasive procedures.

Challenges and Risks

Challenge	Impact	Mitigation Strategies
Regulatory restrictions	Reduced market access	Engagement with regulators, compliance innovations
Patent expirations	Price erosion	Portfolio diversification, innovation
Supply chain vulnerabilities	Disrupted sales	Diversify manufacturing, local sourcing

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Deep-Dive: Comparative Market and Financial Analysis

Aspect	Branded DIPRIVAN	Leading Generics	Market Dynamics
Revenue	~$1.2 billion (2022)	~$300-600 million	Branded maintains premium, generics grow rapidly post-patent expiry
Pricing	Premium	Discounted (~20-30%)	Price competition intensifies post-patent expiry
Market Penetration	Global leader	Regional players	Shifting market share influence
R&D Investment	continuous update, safety innovations	Minimal	Focused on cost efficiency

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Key Takeaways

• Market Growth Prospect: The global DIPRIVAN market is projected to grow at 5.8% CAGR through 2030, driven by rising surgical and ICU procedures, especially in Asia-Pacific.
• Patent Expiry and Generics: Patent expirations beginning around 2024 are leading to increased generic competition, pressuring branded sales and margins.
• Regulatory and Safety Environment: Stringent safety regulations and off-label restrictions influence sales strategies and product development.
• Market Opportunities: Emerging markets present high-growth opportunities; innovations like liposomal formulations and digital safety tools are areas for future differentiation.
• Supply Chain Resilience: Diversification and local manufacturing are critical to mitigate pandemic-related vulnerabilities.

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5 FAQs about DIPRIVAN’s Market Dynamics and Financial Trajectory

Q1: How will patent expirations affect DIPRIVAN’s market share and profitability?
Patent expirations forecasted from 2024 onward will lead to increased generic entries, resulting in significant price erosion (estimated at 20-30%) and reduced profit margins for branded DIPRIVAN. Companies that diversify portfolios or innovate may mitigate revenue decline.

Q2: What regional markets are most promising for growth?
Asia-Pacific and Latin America exhibit rapid expansion potential due to increasing surgical volumes, expanding healthcare infrastructure, and rising adoption of anesthesia services.

Q3: How has the COVID-19 pandemic influenced DIPRIVAN's sales?
Pandemic-driven ICU capacity expansion led to a temporary surge in demand, especially for sedative use in critical care. However, post-pandemic normalization might temper growth, emphasizing the need for strategic market positioning.

Q4: What are the primary risks confronting DIPRIVAN’s market future?
Patent cliff, regulatory restrictions, price competition from generics, supply chain disruptions, and evolving safety protocols pose ongoing risks.

Q5: What innovations are expected to sustain DIPRIVAN’s competitiveness?
Advances in drug formulations (liposomal versions), infusion safety monitoring, and targeted delivery mechanisms are areas to reinforce market presence amid competitive pressures.

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References

1. Grand View Research. (2022). Injectable Anesthetics Market Size, Share & Trends.
2. International Healthcare Insights. (2022). Global Surgical Procedures Statistics.
3. Sandoz Company Reports. (2022). Generic Propofol Market Analysis.
4. U.S. Food and Drug Administration (FDA). (2022). Regulatory Updates on Anesthetic Agents.
5. World Health Organization. (2022). Global Surgery Volume Data.

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In conclusion, DIPRIVAN’s market landscape is shaped by evolving regulatory policies, patent expirations, emerging markets, and innovation trajectories. Stakeholders must adopt dynamic strategies to capitalize on growth opportunities while navigating competitive and regulatory challenges effectively.