Propofol - Generic Drug Details

What are the generic sources for propofol and what is the scope of freedom to operate?

Propofol is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa, Amneal, Aspiro, Avet Lifesciences, Dr Reddys, Hikma, Hospira, Innopharma, Sagent Pharms Inc, Teva Parenteral, and Watson Labs Inc, and is included in eleven NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Propofol has one patent family member in one country.

There are twelve drug master file entries for propofol. Eleven suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for propofol

International Patents:	1
US Patents:	1
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	1,914
Patent Applications:	6,601
Drug Prices:	Drug price trends for propofol
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for propofol
What excipients (inactive ingredients) are in propofol?	propofol excipients list
DailyMed Link:	propofol at DailyMed

See drug prices for propofol

Recent Clinical Trials for propofol

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

Sponsor	Phase
University of Alabama at Birmingham	Phase 1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	N/A
Assiut University	Phase 3

See all propofol clinical trials

Generic filers with tentative approvals for PROPOFOL

Applicant	Application No.	Strength	Dosage Form
		10MG/ML	INJECTABLE; INJECTION
		10MG/ML	INJECTABLE; INJECTION
		10MG/ML	INJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for propofol

Drug Class	General Anesthetic
Physiological Effect	General Anesthesia

Medical Subject Heading (MeSH) Categories for propofol

Anesthetics, Intravenous

Hypnotics and Sedatives

Anatomical Therapeutic Chemical (ATC) Classes for propofol

N01AX	Other general anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

US Patents and Regulatory Information for propofol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aspiro	PROPOFOL	propofol	INJECTABLE;INJECTION	217013-001	Jun 20, 2024	AB	RX	No	No
Avet Lifesciences	PROPOFOL	propofol	INJECTABLE;INJECTION	206408-001	Oct 12, 2021	AB	RX	No	No
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-001	Oct 2, 1989		DISCN	No	No
Hikma	PROPOFOL	propofol	INJECTABLE;INJECTION	074848-001	Apr 19, 2005	AB	RX	No	No
Innopharma	PROPOFOL	propofol	INJECTABLE;INJECTION	205576-001	Sep 16, 2020	AB	RX	No	No

Expired US Patents for propofol

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	5,731,356*PED
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996	5,731,355*PED

International Patents for propofol

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005007131

Propofol Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Propofol

Introduction

Propofol, a widely used anesthetic and sedative, is experiencing significant growth in the global market. This article delves into the market dynamics, financial trajectory, and key factors influencing the propofol market.

Global Market Size and Growth

The global propofol market is substantial and growing rapidly. As of 2024, the market size is estimated at USD 1,352.2 million and is projected to expand at a compound annual growth rate (CAGR) of 10.80% from 2024 to 2031[1].

Regional Market Analysis

North America

North America holds the largest market share, accounting for approximately 40% of the global revenue with a market size of USD 540.88 million in 2024. This region is expected to grow at a CAGR of 9.0% from 2024 to 2031, driven by the increasing prevalence of chronic diseases, advancements in healthcare infrastructure, and favorable reimbursement policies[1].

Europe

Europe is the second-largest market, with a market size of USD 405.66 million in 2024 and a projected CAGR of 9.3% from 2024 to 2031. The region's growing geriatric population and increasing investments in drug development are key drivers of market growth[1].

Asia Pacific

The Asia Pacific region is growing at the fastest rate, with a market size of USD 311.01 million in 2024 and a CAGR of 12.8% from 2024 to 2031. This growth is attributed to the expanding healthcare infrastructure and the rising demand for surgical interventions[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa are also experiencing significant growth, with market sizes of USD 67.61 million and USD 27.04 million in 2024, respectively. These regions are expected to grow at CAGRs of 10.2% and 10.5% from 2024 to 2031, driven by investments in healthcare and the increasing prevalence of chronic diseases[1].

Market Segments

Application

The propofol market is segmented into procedural sedation and general anesthesia. General anesthesia holds a significant market share due to the rising number of surgical procedures globally. According to the U.S. National Institutes of Health, approximately 60,000 people in the U.S. undergo surgery under general anesthesia every day[4].

Distribution Channel

Hospitals are expected to garner the largest market share over the forecast period due to the high number of admissions and the abundant availability of medical equipment in hospital facilities[4].

Growth Drivers

Increasing Surgical Procedures

The global increase in surgical procedures, including general surgical, orthodontic, dental, and cataract removal surgeries, is a major driver of the propofol market. Approximately 235 million surgeries are performed worldwide each year, with 58.9% of these occurring in high-income countries[4].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure and technology enhance the efficiency and safety of surgical procedures, thereby increasing the demand for propofol. Ambulatory surgery centers, which offer convenient settings for outpatient procedures, are also contributing to market growth[1][4].

Cost-Effectiveness

Propofol has been shown to be a cost-effective option compared to other sedatives like midazolam. A study found that using propofol resulted in average savings of $17.33 per sedation performed, driven by shorter recovery times[2].

Challenges

Regulatory Approvals

While propofol is widely used, new formulations and dosages must undergo rigorous regulatory approvals. For instance, Hikma Pharmaceuticals PLC received FDA approval for its propofol injectable emulsion in 2020, highlighting the importance of regulatory clearance[4].

Clinical Outcomes

There is ongoing research to compare the clinical outcomes of different anesthetic medications, including propofol. A $33 million study funded by the Patient-Centered Outcomes Research Institute (PCORI) aims to compare intravenous propofol with inhaled anesthetic drugs to determine which offers better patient recovery experiences and clinical outcomes[5].

Financial Trajectory

Revenue Projections

The global propofol market is expected to reach USD 1.91 billion by 2036, growing at a CAGR of more than 5.2% from 2024 to 2036[4].

Regional Revenue

North America is projected to maintain its position as the largest revenue-generating region, followed by Europe. The Asia Pacific region is expected to show the highest growth rate due to its expanding healthcare sector[1][4].

Industry Trends

Minimally Invasive Surgeries

The growing requirement for minimally invasive surgery procedures globally is driving the demand for propofol. These procedures often require effective and safe anesthetic agents, making propofol a preferred choice[4].

Research and Development

Top market players are investing in research and development to commercialize new products and formulations of propofol. This is expected to offer ample growth opportunities in the near future[4].

Key Takeaways

• The global propofol market is projected to grow significantly, driven by increasing surgical procedures and advancements in healthcare infrastructure.
• North America and Europe are the largest markets, with the Asia Pacific region showing the highest growth rate.
• General anesthesia is the dominant application segment due to its widespread use in surgical procedures.
• Cost-effectiveness and shorter recovery times make propofol a preferred choice over other sedatives.
• Ongoing research aims to compare the clinical outcomes of propofol with other anesthetic medications.

FAQs

Q: What is the current global market size of propofol? A: The global propofol market size is estimated at USD 1,352.2 million in 2024[1].

Q: What is the projected CAGR for the global propofol market from 2024 to 2031? A: The global propofol market is expected to grow at a CAGR of 10.80% from 2024 to 2031[1].

Q: Which region holds the largest market share for propofol? A: North America holds the largest market share, accounting for approximately 40% of the global revenue[1].

Q: What are the main drivers of the propofol market growth? A: The main drivers include the increasing number of surgical procedures, advancements in healthcare infrastructure, and the cost-effectiveness of propofol[1][2][4].

Q: Are there any ongoing studies comparing propofol with other anesthetic medications? A: Yes, a $33 million study funded by PCORI is comparing intravenous propofol with inhaled anesthetic drugs to determine which offers better patient recovery experiences and clinical outcomes[5].

Sources

1. Cognitive Market Research: Propofol market Will Grow at a CAGR of 10.80% from 2024 to 2031.
2. PubMed: A cost-effectiveness analysis of propofol versus midazolam for procedural sedation.
3. Precedence Research: General Anesthesia Drugs Market Size to Hit USD 7.79 Bn by 2034.
4. Research Nester: Propofol Market Size & Share, Growth Outlook 2036.
5. Washington University School of Medicine: $33 million to support study comparing anesthetic medications.