LIDOCAINE; PRILOCAINE - Generic Drug Details

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

Lidocaine; prilocaine is the generic ingredient in three branded drugs marketed by Teva Branded Pharm, Alembic, Encube, Fougera Pharms, Hikma, Padagis Us, Pai Holdings Pharm, Rhodes Pharms, Astrazeneca, and Dentsply Pharm, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

Ten suppliers are listed for this compound.

Summary for LIDOCAINE; PRILOCAINE

US Patents:	0
Tradenames:	3
Applicants:	10
NDAs:	10
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	75
DailyMed Link:	LIDOCAINE; PRILOCAINE at DailyMed

Recent Clinical Trials for LIDOCAINE; PRILOCAINE

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

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

See all LIDOCAINE; PRILOCAINE clinical trials

Pharmacology for LIDOCAINE; PRILOCAINE

Drug Class	Amide Local Anesthetic Antiarrhythmic
Physiological Effect	Local Anesthesia

Anatomical Therapeutic Chemical (ATC) Classes for LIDOCAINE; PRILOCAINE

C01BB	Antiarrhythmics, class Ib
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

C05AD	Local anesthetics
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D04AB	Anesthetics for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

R02AD	Anesthetics, local
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

S01HA	Local anesthetics
S01H	LOCAL ANESTHETICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02DA	Analgesics and anesthetics
S02D	OTHER OTOLOGICALS
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for LIDOCAINE; PRILOCAINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fougera Pharms	LIDOCAINE AND PRILOCAINE	lidocaine; prilocaine	CREAM;TOPICAL	076453-001	Aug 18, 2003	AB	RX	No	Yes
Hikma	LIDOCAINE AND PRILOCAINE	lidocaine; prilocaine	CREAM;TOPICAL	076290-001	Sep 25, 2003		DISCN	No	No
Teva Branded Pharm	EMLA	lidocaine; prilocaine	CREAM;TOPICAL	019941-001	Dec 30, 1992		DISCN	Yes	No
Pai Holdings Pharm	LIDOCAINE AND PRILOCAINE	lidocaine; prilocaine	CREAM;TOPICAL	205887-001	Jun 29, 2018	AB	RX	No	No
Astrazeneca	EMLA	lidocaine; prilocaine	DISC;TOPICAL	020962-001	Feb 4, 1998		DISCN	No	No
Encube	LIDOCAINE AND PRILOCAINE	lidocaine; prilocaine	CREAM;TOPICAL	076320-001	Aug 27, 2003	AB	RX	No	No
Padagis Us	LIDOCAINE AND PRILOCAINE	lidocaine; prilocaine	CREAM;TOPICAL	212482-001	Jul 27, 2021	AB	RX	No	No

Expired US Patents for LIDOCAINE; PRILOCAINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	EMLA	lidocaine; prilocaine	CREAM;TOPICAL	019941-001	Dec 30, 1992
Dentsply Pharm	ORAQIX	lidocaine; prilocaine	GEL;PERIODONTAL	021451-001	Dec 19, 2003
Teva Branded Pharm	EMLA	lidocaine; prilocaine	CREAM;TOPICAL	019941-001	Dec 30, 1992

EU/EMA Drug Approvals for LIDOCAINE; PRILOCAINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Recordati Ireland Ltd.	Fortacin	lidocaine, prilocaine	EMEA/H/C/002693 Treatment of primary premature ejaculation in adult men.	Authorised	no	no	no	2013-11-15
Plethora Pharma Solutions Limited	Senstend	lidocaine, prilocaine	EMEA/H/C/005298 Senstend is indicated for the treatment of primary premature ejaculation in adult men.	Withdrawn	no	no	no	2019-11-14

LIDOCAINE; PRILOCAINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Lidocaine and Prilocaine Cream

Introduction

Lidocaine and prilocaine are amide-type local anesthetic agents widely used in various medical procedures, including dermatology, cosmetic surgeries, and minor invasive treatments. The market for lidocaine and prilocaine cream has been experiencing significant growth, driven by several key factors.

Market Size and Growth Projections

The lidocaine and prilocaine cream market is anticipated to witness substantial growth over the next few years. Here are some key projections:

• The market is expected to grow at a compound annual growth rate (CAGR) of 7.99% from 2024 to 2031, transitioning from a valuation of USD 6.6 billion in 2024 to USD 11.3 billion by 2031[4].
• The global local anesthesia drugs market, which includes lidocaine and prilocaine, was valued at USD 2,568.64 million in 2021 and is projected to reach USD 3,984 million by 2030, growing at a CAGR of 5% during the forecast period[3].

Key Drivers of Market Growth

Several factors are driving the growth of the lidocaine and prilocaine cream market:

Increasing Demand for Topical Anesthetics

The rising demand for topical anesthetics in various medical fields, including dermatology and cosmetic surgeries, is a significant driver. Procedures like laser treatments, tattoos, and minor surgeries are increasingly using lidocaine and prilocaine creams for pain relief[4].

Growing Prevalence of Skin Conditions

The rise in dermatological conditions and treatments, where local pain management is crucial, further fuels market demand. Skin conditions and the need for effective pain management solutions are contributing to the market's expansion[4].

Advancements in Product Formulations

Innovations in pharmaceutical formulations, offering enhanced efficacy and longer-lasting relief, are driving adoption and expanding the market's potential. Newer formulations are making these creams more effective and user-friendly[4].

Urbanization and Demographic Changes

The rising urban population, especially in regions like Asia-Pacific, is propelling the demand for lidocaine and prilocaine cream. Urban centers have a heightened need for these products, driven by lifestyle changes and increased access to healthcare services[4].

Market Segmentation

The market for lidocaine and prilocaine cream is segmented based on several criteria:

Type

The market is categorized by the type of cream, such as 15G, 30G, and other variations. These different types cater to various medical needs and procedures[1].

Application

The application segments include hospitals, clinics, and other healthcare settings. The demand from these segments is driven by the increasing number of surgeries and medical procedures[1].

Geographical Regions

The market is analyzed across geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its unique market dynamics and growth prospects[1].

Regional Market Analysis

North America

North America emerged as the largest market for local anesthesia drugs in 2021, with a market share of around 37.1%. The region's growth is driven by the rising number of operations, an aging population, and an increase in chronic health conditions[3].

Asia-Pacific

The Asia-Pacific region is expected to grow at the fastest CAGR during the forecast period. This growth is driven by a large population, rising disposable income, and increasing urbanization, leading to greater demand for lidocaine and prilocaine cream products[3].

Europe

Europe is another major region, characterized by a mature market with well-established infrastructure and consumer preferences. Countries like the UK, Germany, France, and Italy are key players in this region[4].

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 are driving demand in these regions[4].

Competitive Landscape

The market for lidocaine and prilocaine cream is highly competitive, with several key players:

• Companies like Tongfang Pharma, Aspen Pharma, Octavius Pharma, Padagis, and Akorn are prominent in the market[4].
• Strategic consolidations, such as mergers and acquisitions, are common as companies seek to expand their product portfolios and leverage synergies to drive growth and competitiveness[4].

Challenges and Opportunities

Regulatory Environment

Stringent regulations and growing environmental concerns are fostering a shift towards sustainable alternatives, which can be both a challenge and an opportunity for the market. Companies are looking to develop eco-friendly products to meet these demands[4].

Technological Advancements

Access to new technologies through acquisitions and partnerships enables companies to innovate faster and stay ahead of market trends. This is a significant opportunity for market growth and expansion[4].

Pharmacological Overview

Lidocaine and prilocaine work by stabilizing neuronal membranes and inhibiting ionic fluxes, providing effective local anesthesia. Here are some key pharmacological aspects:

• Metabolism and Elimination: Lidocaine is metabolized rapidly by the liver, while prilocaine is metabolized in both the liver and kidneys. The metabolites of these drugs have varying pharmacologic activities[2].
• Distribution and Plasma Protein Binding: Lidocaine and prilocaine have different distribution volumes and plasma protein binding characteristics, which affect their plasma concentrations and efficacy[2].

Key Takeaways

• The lidocaine and prilocaine cream market is poised for significant growth driven by increasing demand for topical anesthetics and advancements in product formulations.
• The market is segmented by type, application, and geographical regions, each with unique growth prospects.
• North America and Asia-Pacific are key regions driving market growth.
• The competitive landscape is characterized by strategic consolidations and innovations in product development.

Frequently Asked Questions (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[4].

2. Which region is expected to grow the fastest in the Lidocaine and Prilocaine Cream Market?

   • The Asia-Pacific region is expected to grow at the fastest CAGR during the forecast period[3].

3. What are the primary drivers of the Lidocaine and Prilocaine Cream Market?

   • The primary drivers include increasing demand for topical anesthetics, growing prevalence of skin conditions, and advancements in product formulations[4].

4. Who are the key players in the Lidocaine and Prilocaine Cream Market?

   • Key players include Tongfang Pharma, Aspen Pharma, Octavius Pharma, Padagis, and Akorn[4].

5. What are the pharmacological effects of Lidocaine and Prilocaine?

   • Lidocaine and prilocaine stabilize neuronal membranes by inhibiting ionic fluxes, providing effective local anesthesia[2].

Cited Sources:

1. Market Research Intellect - Global Lidocaine and Prilocaine Cream Market Size, Trends and Forecasts[1].
2. FDA - EMLA CREAM (lidocaine 2.5% and Prilocaine 2.5%)[2].
3. Spherical Insights - Global Local Anesthesia Drugs Market Trends, Size, Forecast to 2030[3].
4. OpenPR - Lidocaine and Prilocaine Cream Market Size, Share and Forecast[4].