PRILOCAINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for prilocaine hydrochloride and what is the scope of patent protection?

Prilocaine hydrochloride is the generic ingredient in four branded drugs marketed by Astrazeneca, Dentsply Pharm, and Septodont Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for prilocaine hydrochloride. One supplier is listed for this compound.

Summary for PRILOCAINE HYDROCHLORIDE

US Patents:	0
Tradenames:	4
Applicants:	3
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	108
Patent Applications:	350
What excipients (inactive ingredients) are in PRILOCAINE HYDROCHLORIDE?	PRILOCAINE HYDROCHLORIDE excipients list
DailyMed Link:	PRILOCAINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PRILOCAINE HYDROCHLORIDE

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

Sponsor	Phase
Assiut University	N/A
Universitas Sebelas Maret	Phase 4
Indonesia Endowment Fund for Education	Phase 4

See all PRILOCAINE HYDROCHLORIDE clinical trials

Pharmacology for PRILOCAINE HYDROCHLORIDE

Drug Class	Amide Local Anesthetic
Physiological Effect	Local Anesthesia

Medical Subject Heading (MeSH) Categories for PRILOCAINE HYDROCHLORIDE

Anesthetics, Local

Anatomical Therapeutic Chemical (ATC) Classes for PRILOCAINE HYDROCHLORIDE

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

US Patents and Regulatory Information for PRILOCAINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	CITANEST PLAIN	prilocaine hydrochloride	INJECTABLE;INJECTION	014763-007	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Dentsply Pharm	CITANEST PLAIN DENTAL	prilocaine hydrochloride	INJECTABLE;INJECTION	021382-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astrazeneca	CITANEST	prilocaine hydrochloride	INJECTABLE;INJECTION	014763-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astrazeneca	CITANEST	prilocaine hydrochloride	INJECTABLE;INJECTION	014763-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No

PRILOCAINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prilocaine Hydrochloride

Introduction

Prilocaine hydrochloride, a local anesthetic drug, is widely used in various medical procedures to provide pain relief. The market for prilocaine hydrochloride is influenced by several key factors, including increasing demand for minimally invasive procedures, advancements in pharmaceutical formulations, and demographic changes.

Market Growth Drivers

Increasing Demand for Minimally Invasive Procedures

The growing preference for non-invasive and minimally invasive medical procedures, such as laser treatments, tattoos, and minor surgeries, is significantly driving the demand for prilocaine hydrochloride. This trend is particularly evident in cosmetic surgeries and dermatological treatments where local pain management is crucial[1].

Advancements in Pharmaceutical Formulations

Innovations in pharmaceutical formulations have enhanced the efficacy and duration of action of prilocaine hydrochloride. These advancements have made the drug more appealing to both healthcare providers and patients, contributing to its increased adoption and market growth[1].

Rising Prevalence of Chronic Diseases

The increasing incidence of chronic diseases, such as cancer and tumors, which often require painful treatments, has fueled the demand for local anesthetics like prilocaine hydrochloride. These drugs help in making surgical procedures less traumatic by numbing the affected area[3].

Market Size and Forecast

Global Local Anesthesia Drugs Market

The global local anesthesia drugs market, which includes prilocaine hydrochloride, was valued at $2,643.50 million in 2021 and is projected to grow at a CAGR of 6.4% to reach $4,724.80 million by 2031. This growth is driven by the increasing need for pain management in various surgical procedures[3].

Specific Market Projections for Prilocaine Hydrochloride

The Lidocaine and Prilocaine Cream market, which is closely related to prilocaine hydrochloride, is anticipated to witness a CAGR of 7.99% from 2024 to 2031, growing from $6.6 billion in 2024 to $11.3 billion by 2031. This indicates a robust financial trajectory for products containing prilocaine hydrochloride[1].

Regional Analysis

North America

North America is one of the dominant regions in the local anesthesia drugs market, including prilocaine hydrochloride. The region's well-established healthcare infrastructure and high demand for cosmetic and plastic surgeries contribute to its significant market share[3].

Europe

Europe is another major region, characterized by a mature market with well-established infrastructure and consumer preferences. Countries such as the UK, Germany, France, and Italy drive the demand for local anesthetics in this region[1].

Asia-Pacific

The Asia-Pacific region is rapidly growing, driven by countries like China, Japan, India, and South Korea. The large population, rising disposable income, and increasing urbanization in this region are key factors propelling the demand for prilocaine hydrochloride and other local anesthetics[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa represent emerging markets with promising growth potential. Economic diversification efforts, urbanization, and a young population in these regions are driving the demand for local anesthesia drugs, including prilocaine hydrochloride[1].

Competitive Landscape

Key Players

The market for prilocaine hydrochloride is competitive, with key players such as Tongfang Pharma, Aspen Pharma, Octavius Pharma, Padagis, and Akorn. These companies are involved in strategic consolidations, mergers, and acquisitions to expand their product portfolios and leverage synergies for growth[1].

Innovations and Acquisitions

Companies in the local anesthesia drugs market are focusing on acquiring new technologies and intellectual property to innovate faster and stay ahead of market trends. For instance, acquisitions provide access to new formulations and talent, enabling companies to enhance their product offerings and competitiveness[1].

Financial Insights

Revenue Projections

The local anesthesia drugs market, which includes prilocaine hydrochloride, is expected to generate significant revenue. By 2031, the global local anesthesia drugs market is projected to reach $4,724.80 million, up from $2,643.50 million in 2021[3].

Market Segmentation

The market is segmented based on drug type, application, and route of administration. Prilocaine hydrochloride, along with other local anesthetics like lidocaine and bupivacaine, contributes significantly to the overall market revenue. The application in general surgeries, plastic surgeries, and cosmetic surgeries further fuels the financial growth of the market[2].

Regulatory and Environmental Factors

Regulatory Approvals

Regulatory approvals and compliance are crucial for the growth of the prilocaine hydrochloride market. For example, the FDA's approval of new anesthetic drugs and formulations can significantly impact market dynamics[5].

Environmental Concerns

Growing environmental concerns and stringent regulations are fostering a shift towards sustainable and eco-friendly alternatives in the pharmaceutical industry. This trend may influence the production and packaging of prilocaine hydrochloride products, potentially affecting their market appeal and cost structure[1].

Key Takeaways

• Growing Demand: Increasing demand for minimally invasive procedures and rising prevalence of chronic diseases drive the market growth for prilocaine hydrochloride.
• Regional Growth: North America, Europe, and the Asia-Pacific region are key markets, with emerging markets in Latin America and the Middle East & Africa showing promising growth potential.
• Competitive Landscape: The market is competitive, with key players focusing on strategic acquisitions and innovations to enhance their product offerings.
• Financial Trajectory: The market is projected to grow significantly, with the global local anesthesia drugs market expected to reach $4,724.80 million by 2031.
• Regulatory and Environmental Factors: Regulatory approvals and environmental concerns play a crucial role in shaping the market dynamics and future growth of prilocaine hydrochloride.

FAQs

1. What is the projected CAGR for the Lidocaine and Prilocaine Cream market from 2024 to 2031?

   • The Lidocaine and Prilocaine Cream market is anticipated to witness a CAGR of 7.99% from 2024 to 2031[1].

2. Which regions are driving the growth of the local anesthesia drugs market?

   • North America, Europe, and the Asia-Pacific region are the primary drivers, with emerging markets in Latin America and the Middle East & Africa also showing growth potential[1][3].

3. What are the key factors driving the demand for prilocaine hydrochloride?

   • The growing demand for minimally invasive procedures, advancements in pharmaceutical formulations, and the rising prevalence of chronic diseases are key drivers[1][3].

4. Who are the key players in the prilocaine hydrochloride market?

   • Key players include Tongfang Pharma, Aspen Pharma, Octavius Pharma, Padagis, and Akorn[1].

5. How is the global local anesthesia drugs market expected to grow by 2031?

   • The global local anesthesia drugs market is projected to grow at a CAGR of 6.4% to reach $4,724.80 million by 2031[3].

Sources

1. Lidocaine and Prilocaine Cream Market Size, Share and Forecast - OpenPR
2. Local Anesthesia Drugs Market is estimated to be US$ 8.5 billion by 2032 - GlobeNewswire
3. Local Anesthesia Drugs Market Size & Industry Trends: 2031 - Research Dive
4. Local Anesthesia Drugs Market Size & Share Report, 2030 - Grand View Research
5. Prilocaine - University of Maryland, Baltimore - University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI)