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.

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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	144
Patent Applications:	4,461
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
Nyree Penn	PHASE1
PROSOMNIA Sleep Health & Wellness	PHASE1
Masimo Corporation	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

International Patents for DIPRIVAN

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

Country	Patent Number	Title	Estimated Expiration
Austria	226817
Austria	312625
Australia	1898895
Australia	710143

Market Dynamics and Financial Trajectory for DIPRIVAN

Last updated: February 20, 2026

What is DIPRIVAN and its Market Position?

DIPRIVAN (propofol) is a widely used intravenous anesthetic agent. It is essential in hospitals for induction and maintenance of anesthesia, sedation for mechanically ventilated patients, and sedation for diagnostic procedures. The drug is marketed by Fresenius Kabi, with other generic manufacturers participating post-patent expiration.

As of 2022, DIPRIVAN remains the dominant drug in the anesthetic market, holding approximately 60% of the global intravenous anesthetic market share. The drug's stability, rapid onset, and quick recovery time solidify its position.

What are the Key Market Drivers?

• Increasing surgical procedures: Global surgeries contribute to the rising demand, projected to grow at approximately 5% annually through 2030.
• Growth in ICU admissions: The COVID-19 pandemic increased sedation needs in ICUs, a trend continuing due to aging populations.
• Preference for intravenous anesthesia: Shift from inhalation agents to IV approaches improves demand for DIPRIVAN.
• Technological advances: Monitoring systems improve safety profiles, broadening use.

How Do Patent Status and Generic Competition Affect the Market?

DIPRIVAN was under patent protection until 2015. Its patent expiry led to increased generic competition, reducing prices by approximately 30% within the first year after patent expiration. The generic market accounted for over 40% of global sales by 2018.

New formulations and licensing agreements have sustained the drug’s revenue streams despite competition. Fresenius Kabi and Teva Pharmaceuticals are the primary generic suppliers.

What is the Revenue Trajectory?

• Pre-2015: Revenue approached $1.2 billion annually (global sales).
• Post-patent expiry: Sales plateaued, then declined slightly to around $1.0 billion by 2018.
• Recent estimates: Global sales stabilized at ~$950 million in 2022, with a CAGR of approximately -2% since 2018.
• Regional variations: North America dominates with 55% of sales, followed by Europe (25%) and Asia-Pacific (20%).

How Do Pricing and Market Access Influence Financial Outcomes?

Pricing transparency has increased, with hospitals and insurers pushing for lower prices. In North America, DIPRIVAN's average price per dose declined by 15% from 2015 to 2022. Market access policies favor generics, further compressing margins but expanding volume.

Insurance reimbursement frameworks support continued use in hospitals, although budget constraints influence procurement strategies.

What are Future Market Trends?

• Emergence of biosimilars and alternative agents: While biosimilars are limited for DIPRIVAN, the development of next-generation anesthetics could impact demand.
• Regional growth in Asia-Pacific: Markets in China and India forecast to grow at 6-8% annually due to expanding surgical infrastructures.
• Increased safety features: Formulations with improved safety profiles may command premium pricing, mitigating volume declines.
• Digital health integration: Monitoring and sedation management systems could influence drug utilization patterns.

What Are the Risks and Challenges?

• Pricing pressures: Ongoing efforts to reduce healthcare costs could further depress prices.
• Regulatory shifts: Stringent safety regulations or changes in formularies may restrict use.
• Patent litigation and exclusivity issues: Potential legal disputes could impact supply or pricing.
• Innovation lag: Competition from newer agents with better safety profiles could erode market share.

Summary Table of Market Data

Aspect	Data
Market Size (2022)	~$950 million
CAGR (2018-2022)	-2%
Top Markets	North America (55%), Europe (25%), Asia-Pacific (20%)
Patent Expiry	2015
Generic Coverage (%)	40% in 2018
Price Decline Post-patent	Approx. 15% reduction in North America in 2015–2022

Key Takeaways

DIPRIVAN remains a critical drug within the intravenous anesthetic market, with demand sustained by surgical volume and ICU sedation needs. Patent expirations led to increased competition and price erosion, with global sales stabilizing around $950 million. Growth prospects rely heavily on regional expansion, safety innovations, and procedural volume increases. Price sensitivity and regulatory environments present ongoing risks for revenue growth.

FAQs

1. How does DIPRIVAN's patent status influence its market?
Patent expiration in 2015 resulted in generic entry, reducing prices and expanding competitive pressure, which gradually decreased revenue growth.

2. What regions represent the largest growth opportunities?
Asia-Pacific, especially China and India, exhibit the highest growth potential due to expanding healthcare infrastructure and surgical capacity.

3. Are there new drugs threatening DIPRIVAN's market share?
Emerging anesthetics with improved safety profiles or faster recovery times could challenge DIPRIVAN in the future.

4. How do pricing policies impact DIPRIVAN's revenue?
Price reductions driven by hospital negotiations and insurance reimbursement policies limit revenue growth but increase volume and accessibility.

5. What is the outlook for DIPRIVAN in the next five years?
Market stability is expected, with regional growth in emerging markets and potential premium formulations mitigating current price pressures.

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References

[1] MarketWatch. (2022). Global intravenous anesthetics market size and forecast.

[2] IQVIA. (2022). Pharmaceutical sales data.

[3] Healthcare Regulatory Updates. (2022). Changes in anesthesia drug formulary coverage.

[4] PTS Analytics. (2023). Patent and generic drug market trends.

[5] FDA. (2015). Approvals and patent expiration notices.

DrugChatter Q&A for DIPRIVAN

Diprivan 200 mg per 20 ml?