DIPRIVAN Drug Patent Profile

When do Diprivan patents expire, and what generic alternatives are available?

Diprivan is a drug marketed by Fresenius Kabi Usa and is included in one NDA.

The generic ingredient in DIPRIVAN is propofol. There are twelve drug master file entries for this compound. Thirteen 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

US Patents:	0
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DIPRIVAN

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

International Patents for DIPRIVAN

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2147432	ЭМУЛЬСИИ ТИПА МАСЛО В ВОДЕ, СОДЕРЖАЩИЕ ПРОПОФОЛ И ЭДЕТАТ (EMULSIONS "OIL-IN-WATER" CONTAINING PROPOFOL AND EDETATE)
Japan	4012328
Norway	20041838
Hungary	227951	OIL IN WATER EMULSIONS CONTAINING PROPOFOL AND DISODIUM EDETATE
Belgium	1009198	COMPOSITIONS PHARMACEUTIQUES NOUVELLES CONTENANT DU PROPOFOL.

Investment Scenario and Fundamentals Analysis for Diprivan (Propofol)

Last updated: February 20, 2026

What is Diprivan?

Diprivan (brand name for propofol) is an intravenous anesthetic used for induction and maintenance of anesthesia, as well as sedation in intensive care. Marketed by pharmaceutical companies, notably AstraZeneca (formerly), propofol has a significant footprint in hospital settings.

Market Overview and Key Drivers

Indicator	Data	Source
Global anesthesia market size (2022)	$4.5 billion	MarketsandMarkets[1]
Compound annual growth rate (2022-2027)	6.2%	Fortune Business Insights[2]
Hospital sedation (segment)	65% of market	IQVIA[3]

Drivers:

• Rising surgical volumes globally, projected at 6-8% annual growth.
• Increasing adoption of outpatient procedures.
• Advances in anesthesia techniques favoring agents like propofol.

Product Status and Patents

Aspect	Details	Notes
Patent expiration	2012 (original formulation)	Loss of exclusivity for original patent; generic versions available since then
Market exclusivity	No recent patent protections	Presently, no proprietary formulations under patent protection
Patent filings	No significant new patents for proprietary formulations	Focus on new delivery methods or formulations

Competitive Landscape

Competitors	Market Share (Estimated)	Notes
Generic manufacturers	70-80%	Dominates due to patent expiry of original formulations
Brand (e.g., Diprivan)	20-30%	Niche markets, specific formulations

Patent Challenges & Generic Competition

Following patent expiration, generic versions flooded the market, leading to increased price competition and compressed margins. Some manufacturers have sought new formulations or delivery systems to extend product lifecycle, but no recent patent filings indicating substantial innovation.

Regulatory and Pricing Environment

• Regulatory approvals: Achieved globally, with approvals from FDA, EMA, and other agencies.
• Pricing trends: Price pressures driven by generics. In the US, average price per vial has decreased 25% since 2012.
• Reimbursement: Largely fixed in hospital settings, limiting revenue growth potential.

Clinical and Safety Profile

• Efficacy: Rapid induction and recovery times.
• Safety concerns: Risks of hypotension, respiratory depression, rare allergic reactions.
• Market implications: Safety profile supports wide hospital use, but safety concerns can influence regulatory scrutiny and market acceptance.

Financial and Investment Considerations

• Revenue potential: Stable revenues supported by hospital procurement contracts; limited growth scope due to generic competition.
• Margins: Historically high for proprietary formulations; now compressed.
• R&D focus: Little recent innovation—investment in new formulations or delivery systems presents potential growth avenues.

Future Trends and Opportunities

• Development of novel delivery systems (e.g., inhalable forms).
• Partnering opportunities for smarter infusion devices or biosimilars.
• Market growth is steady but faces pressures from biosimilar and generic price competition.

Risks to Investment

• Patent expiration of key formulations already occurred.
• Intense generic competition limits profit margins.
• Regulatory scrutiny regarding safety may lead to additional warning labels or usage restrictions.
• Healthcare policy changes affecting hospital procurement and reimbursement.

Key Takeaways

• Diprivan remains an integral anesthetic but faces limited growth prospects due to patent expiry and generic competition.
• Revenue stability depends on hospital purchasing power and potential innovation in delivery or formulations.
• Emerging opportunities may exist in adjunct technologies rather than the core product.
• Investments should account for margin pressures and regulatory risks.
• No significant recent patent protection reduces exclusive market control.

FAQs

Q1: What is the market outlook for Diprivan in the next five years?
A1: Growth will be modest, driven by overall anesthesia demand but constrained by generics and pricing pressures.

Q2: Are there patent protections or exclusivities remaining for Diprivan?
A2: No; patents expired around 2012, allowing generic manufacturers widespread market access.

Q3: What are potential avenues for differentiation?
A3: Developing new delivery systems, formulations, or combination products in anesthetic protocols.

Q4: How do safety concerns impact the market?
A4: Safety risks necessitate strict regulatory oversight; safety profiles influence market acceptance but haven't limited use significantly.

Q5: What is the strategic focus for companies involved?
A5: Focus on innovation in delivery technologies, exploring biosimilars, and expanding into emerging markets with growing surgical volumes.

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References:

[1] MarketsandMarkets. (2022). Global Anesthesia Market.
[2] Fortune Business Insights. (2022). Anesthesia Devices and Drugs Market.
[3] IQVIA. (2022). Hospital and Surgical Procedures Data.