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. Twelve 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:	12
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2,224
Patent Applications:	7,124
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
Xijing Hospital	PHASE3
Qianfoshan Hospital	NA
PROSOMNIA Sleep Health & Wellness	PHASE1

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
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-001	Oct 2, 1989		DISCN	No	No
Sagent Pharms Inc	PROPOFOL	propofol	INJECTABLE;INJECTION	075102-001	Jan 4, 1999	AB	RX	No	No
Hikma	PROPOFOL	propofol	INJECTABLE;INJECTION	074848-001	Apr 19, 2005	AB	RX	No	No
Watson Labs Inc	PROPOFOL	propofol	INJECTABLE;INJECTION	205307-001	Dec 22, 2015		DISCN	No	No
Avet Lifesciences	PROPOFOL	propofol	INJECTABLE;INJECTION	206408-001	Oct 12, 2021	AB	RX	No	No
Teva Parenteral	PROPOFOL	propofol	INJECTABLE;INJECTION	075392-001	Sep 19, 2000		DISCN	No	No
Amneal	PROPOFOL	propofol	INJECTABLE;INJECTION	217525-001	Aug 15, 2024	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	8,476,010*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

Market Dynamics and Financial Trajectory for Propofol

Last updated: July 27, 2025

Introduction

Propofol, a short-acting intravenous anesthetic agent, revolutionized anesthesia practices since its approval in the late 1980s. Its rapid onset, quick recovery profile, and favorable safety profile positioned it as a preferred choice for induction and maintenance of anesthesia, sedation in intensive care units, and various procedural applications. Given its pivotal role in the medical landscape, understanding emerging market trends, competitive positioning, regulatory influences, and financial trajectories is essential for stakeholders across the pharmaceutical supply chain.

Market Overview and Size

The global propofol market has experienced steady growth driven by increasing surgical procedures, rising adoption of outpatient and minimally invasive surgeries, and expanding intensive care units worldwide. In 2022, the market was valued approximately at US$2.5 billion, projected to reach over US$4 billion by 2030, registering a compound annual growth rate (CAGR) of around 6-7% [1].

Key growth drivers include:

• Expanding Surgical Volume: Aging populations and rising prevalence of chronic diseases increase demand for anesthesia agents.
• Growth in Outpatient Procedures: Propofol’s rapid recovery makes it ideal for outpatient surgeries, fueling market expansion.
• Developing Healthcare Infrastructure: Emerging economies investing in healthcare facilities enhance access to modern anesthetics.

Market Dynamics

Competitive Landscape

The propofol market comprises major players like Fresenius Kabi, Hikma Pharmaceuticals, Abbott Laboratories, and West-Ward Pharmaceuticals, alongside several regional and generic manufacturers. Patented formulations face generic competition, reducing prices and increasing accessibility.

Innovative formulations, such as lipid emulsion modifications or reduced preservative formulations, aim to improve safety profiles and extend shelf life, providing competitive edges [2].

Regulatory Environment

Regulation influences the market significantly. Approvals from agencies like the FDA and EMA streamline entry into developed markets, whereas slow approvals or stringent post-marketing surveillance in emerging markets can delay product launches or restrict distribution.

Recent regulatory focus on preservative-free formulations and safety concerns around rare adverse events (e.g., Propofol infusion syndrome) have prompted revisions in clinical guidelines, impacting market dynamics [3].

Technological and Clinical Innovations

Advancements in infusion pump technologies, target-controlled infusion systems, and sedation protocols optimize propofol use, supporting broader adoption. The development of alternative agents such as etomidate and dexmedetomidine creates competitive pressures but also signifies evolving anesthesia paradigms.

Additionally, ongoing research into biosimilar and generic equivalents has enhanced price competition, making propofol accessible in cost-sensitive markets.

Supply Chain and Manufacturing Considerations

Manufacturing of propofol involves strict quality controls for lipid emulsion stability, contamination prevention, and preservative removal. Supply chain disruptions—exacerbated during the COVID-19 pandemic—highlight vulnerabilities that could influence market prices and availability.

Raw material shortages, regulatory compliance, and batch consistency are critical factors influencing manufacturers' financial health.

Financial Trajectory and Future Trends

Revenue Growth Opportunities

The propofol market’s growth trajectory hinges on expanding surgical indications, including procedural sedation, intensive care, and critical care applications. The penetration of outpatient procedures, especially in North America and Europe, sustains consistent revenue streams.

Emerging markets represent a significant growth avenue. As healthcare infrastructure improves in Asia-Pacific and Latin America, increased availability and affordability of props foster market expansion [4].

Pricing Dynamics and Reimbursement Policies

Price erosion due to generic competition challenges profitability, compelling manufacturers to innovate formulations and differentiate through quality and safety features. Reimbursement policies influence market uptake; countries prioritizing healthcare spending and favorable reimbursement facilitate adoption.

Technological integration, such as infusion pumps with safety alerts, adds value, permitting premium pricing and differentiation.

Impact of Regulatory and Safety Concerns

Safety concerns over rare adverse events influence prescribing habits and regulatory guidelines, potentially impacting market volumes. Companies investing in risk mitigation, safety profiling, and post-marketing surveillance maintain market stability.

Potential Market Disruptors

Novel sedation agents or alternative delivery methods, such as inhalational sedation, may pose future threats. The development of biodegradable, more stable formulations can enable new administration routes, impacting traditional markets.

Emerging trends like personalized anesthesia protocols leveraging pharmacogenomics may eventually refine anesthesia management but could introduce complexity and cost implications.

Regulatory and Ethical Considerations

Ongoing scrutiny of propofol’s safety profiles underscores the importance of rigorous clinical evaluation and post-market surveillance. Ethical considerations concerning off-label uses, overdose risks, and contraindications must be managed proactively by manufacturers and clinicians.

Market Entry and Investment Considerations

Investment in manufacturing capacities, quality systems, and R&D for formulation innovations remains vital. Regulatory pathways favoring biosimilar and generic development lower barriers to entry, intensifying competition but expanding market reach.

Partnerships and collaborations with healthcare providers enhance distribution channels and support educational initiatives to optimize utilization.

Conclusion

The propofol market presents a resilient yet dynamic landscape characterized by consistent growth driven by technological advancements, expanding healthcare needs, and developing market opportunities. Price competition and regulatory scrutiny necessitate continuous innovation and strategic positioning for market players aiming to sustain profitability amid evolving clinical and economic environments.

Key Takeaways

• The global propofol market is projected to grow at a CAGR of 6-7%, reaching over US$4 billion by 2030.
• Market growth is propelled by rising surgical procedures, outpatient settings, and healthcare infrastructure development in emerging markets.
• Competition from generics and biosimilars exerts downward pressure on prices but encourages formulation innovation focusing on safety.
• Regulatory factors, including safety guidelines and approval processes, significantly influence market accessibility and product offerings.
• Supply chain resilience and quality control are critical to maintaining market stability, especially amid external disruptions.

FAQs

1. How has the COVID-19 pandemic impacted the propofol market?
The pandemic disrupted supply chains, increased demand for ventilated ICU care, and heightened safety concerns, leading to fluctuations in procurement, manufacturing, and clinical use of propofol.

2. What are the key safety concerns associated with propofol?
Rare adverse events such as Propofol infusion syndrome, allergic reactions, and respiratory depression necessitate careful monitoring, influencing clinical guidelines and prescribing practices.

3. Are biosimilars and generics impacting the propofol market?
Yes. The introduction of biosimilars and generics has intensified price competition, expanding access but reducing profit margins for original manufacturers.

4. Which regions are experiencing the fastest growth in propofol usage?
Emerging markets in Asia-Pacific and Latin America exhibit rapid growth due to expanding healthcare infrastructure, increasing surgical procedures, and rising healthcare expenditures.

5. What innovations could influence future propofol market dynamics?
Formulation improvements, safer delivery systems, and personalized anesthesia protocols leveraging pharmacogenomics are potential innovations shaping the future landscape.

---

References:

[1] MarketsandMarkets, "Anesthetics Market," 2022.
[2] IQVIA, "Pharmaceutical Industry Trends," 2021.
[3] FDA Safety Communications, 2020.
[4] WHO Global Health Observatory, "Healthcare Access and Quality," 2022.