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
PROSOMNIA Sleep Health & Wellness	PHASE1
Masimo Corporation	PHASE1
Nyree Penn	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	8,476,010*PED				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	5,714,520*PED
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996	5,908,869*PED
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996	8,476,010*PED
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996	5,731,356*PED

International Patents for DIPRIVAN

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

Country	Patent Number	Title	Estimated Expiration
Japan	H11500737
Brazil	9510452
European Patent Office	0814787	EMULSIONS HUILE DANS L'EAU CONTENANT DU PROPOFOL ET DE L'EDETATE DISODIQUE (OIL IN WATER EMULSIONS CONTAINING PROPOFOL AND DISODIUM EDETATE)
Italy	MI950529

Market Dynamics and Financial Trajectory for DIPRIVAN (Propofol)

Last updated: July 28, 2025

Introduction
DIPRIVAN, the proprietary formulation of propofol by Pfizer, remains a pivotal agent in anesthesia and sedation practices globally. Its market landscape is shaped by evolving healthcare needs, regulatory developments, competition, and technological innovations. This analysis delineates the current market dynamics and projects the financial trajectory of DIPRIVAN over the coming years.

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Market Overview and Segmentation

Propofol, sold under the brand DIPRIVAN, is a short-acting intravenous anesthetic primarily used for induction and maintenance of anesthesia, procedural sedation, and ICU sedation. The drug's key distinguishing feature is its rapid onset and recovery profile, making it preferable in various clinical settings. The global anesthesia drugs market, valued at approximately USD 11 billion in 2022, encompasses intravenously administered anesthetics, including propofol, and is projected to grow at a CAGR of 7% through the next five years (source: MarketsandMarkets).

DIPRIVAN’s market segmentation covers:

• Hospital-based anesthesia
• Ambulatory surgical centers
• Intensive Care Units (ICUs)
• Procedural Sedation in outpatient clinics

Regional variations, with North America and Europe commanding the largest market shares, are driven by high healthcare spending, advanced medical infrastructure, and a substantial volume of surgical procedures.

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Key Market Drivers

1. Rising Surgical Volume and Procedure Complexity:
   Global increases in minimally invasive surgeries and outpatient procedures bolster demand for fast-acting anesthetics like DIPRIVAN.

2. Expanding ICU and Sedation Needs:
   The COVID-19 pandemic amplified ICU sedation requirements, sustaining high utilization rates for propofol formulations [1].

3. Preference for Rapid Recovery Agents:
   Clinicians favor drugs facilitating quick patient turnover, reducing post-anesthesia recovery time, which positions DIPRIVAN favorably.

4. Advances in Anesthetic Imaging and Monitoring:
   Increased adoption of neuromonitoring enhances the precision of anesthetic delivery, leading to higher demand for reliable agents like propofol.

Market Challenges

• Generic Competition:
  While DIPRIVAN remains a premium product, the global market sees significant entry of biosimilar and generic formulations, exerting downward pricing pressure.

• Concerns over Propofol-Related Adverse Effects:
  Risks such as propofol infusion syndrome and allergic reactions necessitate careful monitoring, influencing usage patterns.

• Regulatory Scrutiny:
  Stringent approval processes in emerging markets and evolving safety regulations impact market access and expansion strategies.

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Competitive Landscape

Pfizer’s DIPRIVAN faces competition from several generic manufacturers, as well as newer formulations aiming to improve safety profiles or delivery methods. Key competitors include:

• Sandoz and other generics manufacturers offering cost-effective alternatives.
• Newer agents and adjuncts, such as dexmedetomidine and remifentanil, which supplement but do not replace propofol.

Patent expirations and the prevalence of biosimilars are expected to accelerate generic penetration, challenging the premium pricing traditionally associated with DIPRIVAN.

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Technological and Innovation Trends

Innovations focus on:

• Lipid emulsion formulations that reduce adverse effects.
• Reduced-concentration formulations for safer, more controlled anesthesia induction.
• Delivery system integrations, such as syringe infusion pumps with precision dosing.

These advancements could augment DIPRIVAN’s clinical utility and market share by enhancing safety and ease of administration.

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Regulatory Environment and Global Expansion

Key markets such as China, India, and Brazil offer significant growth potential due to expanding healthcare infrastructure and surgical capacity. However, gaining regulatory approval requires compliance with strict safety and efficacy standards, often leading to phased launches.

In contrast, regions with mature healthcare systems, such as North America and Europe, focus more on optimizing existing use and integrating digital anesthesia monitoring for better outcomes.

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Financial Trajectory and Revenue Forecasts

Historical Performance:
Pfizer generated estimates of approximately USD 1.2 billion in annual revenue from DIPRIVAN in 2022, accounting for its significant market position and volume of use.

Projection (2023–2030):

• Short-term (2023–2025): The market is expected to remain stable, with slight growth driven by surgical volume increases and ICU sedation needs. However, aggressive generic competition could exert margin pressures.
• Medium-term (2026–2028): Market share may decline marginally unless Pfizer innovates or reinforces its value proposition through formulations with improved safety profiles. The rising global middle class and healthcare investments support incremental growth.
• Long-term (2029–2030): The advent of novel anesthetic agents or alternative delivery systems could disrupt the current market structure. Nonetheless, DIPRIVAN is positioned to maintain a significant share in traditional anesthesia settings.

Revenue Impact Factors:

• Pricing strategies and patent litigation outcomes (e.g., generic challenges)
• Market penetration in emerging economies
• Therapeutic innovations that extend indications or improve safety profiles
• Operational efficiencies and supply chain resilience

Considering these dynamics, Pfizer’s DIPRIVAN revenue could experience a CAGR of 2-4% over the next decade, barring disruptive innovation or market shifts.

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Strategic Opportunities and Risks

Opportunities

• Developing next-generation formulations with enhanced safety profiles.
• Expanding into emerging markets with tailored pricing strategies.
• Partnering with hospital systems for integrated anesthetic delivery solutions.

Risks

• The erosion of market share due to biosimilars.
• Regulatory barriers delaying entry into new markets.
• Clinical safety concerns affecting prescribing practices.

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Conclusion
DIPRIVAN remains a vital anesthetic agent within a complex, competitive landscape. Its market dynamics are primarily driven by surgical volume growth, technological advances, and regional healthcare investments. While sustainability in revenue growth faces headwinds from generic competition, strategic innovation and market expansion can offset declines, preserving its critical clinical role.

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Key Takeaways

• Market Stability with Growth Potential: DIPRIVAN’s established clinical utility supports steady demand, especially in hospitals and ICUs worldwide.
• Competitive Pressures: The proliferation of generics poses a significant challenge; Pfizer must leverage innovation and regional expansion to retain profitability.
• Innovation as a Differentiator: Developing safer, more controllable formulations and delivery systems offers opportunities to enhance market positioning.
• Emerging Markets as Growth Engines: Countries with expanding surgical infrastructure present lucrative avenues, provided regulatory pathways are navigated effectively.
• Monitoring Clinical Safety and Regulatory Landscape: Future growth depends on safety profile advancements and compliance with evolving standards.

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FAQs

Q1: How does generic competition impact DIPRIVAN’s market share and pricing?
A: Generics typically lead to substantial price reductions, reducing profit margins for branded formulations like DIPRIVAN. Over time, increased generic penetration can erode market share unless Pfizer innovates or secures new patent protections.

Q2: Are there recent developments in DIPRIVAN formulations to improve safety?
A: Yes, ongoing research aims to develop lipid emulsion modifications and controlled-release formulations to mitigate adverse effects and enhance safety profiles.

Q3: What is the outlook for DIPRIVAN’s revenue in the emerging markets?
A: With expanding healthcare infrastructure and rising surgical volumes, emerging markets offer substantial growth opportunities. Successful regulatory approvals and tailored pricing strategies are key to market entry.

Q4: How does technological innovation influence DIPRIVAN's market trajectory?
A: Innovations like digital infusion pumps, targeted delivery systems, and combination anesthetic protocols can improve clinical outcomes, strengthening DIPRIVAN’s appeal to clinicians.

Q5: What regulatory challenges could affect DIPRIVAN's future?
A: Stringent safety and efficacy standards, especially in complex markets like China and India, can delay approvals and limit market expansion. Compliance with evolving pharmacovigilance requirements is also crucial.

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Sources
[1] MarketsandMarkets, "Anesthesia Drugs Market," 2022.