Lidocaine; tetracaine - Generic Drug Details

What are the generic drug sources for lidocaine; tetracaine and what is the scope of freedom to operate?

Lidocaine; tetracaine is the generic ingredient in two branded drugs marketed by Crescita Therap and Galen Specialty, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lidocaine; tetracaine has seven patent family members in seven countries.

One supplier is listed for this compound.

Summary for lidocaine; tetracaine

International Patents:	7
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	61
DailyMed Link:	lidocaine; tetracaine at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for lidocaine; tetracaine

Constraining patent/regulatory exclusivity:

10,603,293

Dosage:

CREAM;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for lidocaine; tetracaine

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

Sponsor	Phase
Juerg Hafner	Phase 2
Cutia Therapeutics（Wuxi）Co.,Ltd	Phase 3
Merz North America, Inc.	Phase 1

See all lidocaine; tetracaine clinical trials

Pharmacology for lidocaine; tetracaine

Drug Class	Amide Local Anesthetic Antiarrhythmic Ester Local Anesthetic
Physiological Effect	Local Anesthesia

Anatomical Therapeutic Chemical (ATC) Classes for lidocaine; tetracaine

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

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

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

N01BA	Esters of aminobenzoic acid
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

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; tetracaine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005		DISCN	Yes	No
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		DISCN	Yes	No	10,603,293		Y
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		DISCN	Yes	No	10,350,180		Y
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		DISCN	Yes	No	10,751,305		Y

Expired US Patents for lidocaine; tetracaine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005	6,465,006
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005	6,306,431
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006	5,919,479
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005	5,658,583

International Patents for lidocaine; tetracaine

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2011088333
Brazil	112012017554	formulações de anestésicas locais formadoras de sólido para controle da dor
Mexico	2012008168	FORMULACIONES ANESTESICAS LOCALES QUE FORMAN SOLIDOS PARA CONTROL DEL DOLOR. (SOLID-FORMING LOCAL ANESTHETIC FORMULATIONS FOR PAIN CONTROL.)
Australia	2011205730	Solid-forming local anesthetic formulations for pain control

Lidocaine; tetracaine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lidocaine and Tetracaine

Introduction

Lidocaine and tetracaine are two of the most widely used local anesthetic drugs, playing crucial roles in various medical and surgical procedures. Understanding the market dynamics and financial trajectory of these drugs is essential for stakeholders in the healthcare and pharmaceutical industries.

Global Market Size and Growth

The global local anesthesia drugs market, which includes lidocaine and tetracaine, was valued at USD 4.01 billion in 2023 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.6% from 2024 to 2030, reaching an estimated USD 5.14 billion by 2030[1][4].

Market Share of Lidocaine

Lidocaine dominates the local anesthesia drugs market, accounting for a market share of 28.7% in 2023. This dominance is attributed to its extensive use in both injectable and topical forms. Lidocaine is widely used in various applications, including surgical procedures, pain management, and cosmetic surgeries[1][4].

Growth Drivers

Several factors are driving the growth of the lidocaine and tetracaine markets:

Increasing Surgical Procedures

The rise in the number of surgical procedures, including cosmetic surgeries, dental procedures, and plastic surgeries, is a significant driver. Approximately 65% of total surgical procedures require post-operative pain management, which boosts the demand for local anesthesia drugs[4].

Geriatric Population

The increasing geriatric population, which is more prone to chronic diseases and surgeries, is another key driver. By 2050, the proportion of the population above 60 years is expected to reach 22%, according to the World Health Organization[1].

Advancements in Drug Delivery Systems

Advancements in drug delivery systems, such as the development of emulgel and cream formulations, are enhancing the efficacy and duration of action of lidocaine and tetracaine. For instance, emulgel formulations of lidocaine-tetracaine combinations have shown faster release rates compared to cream formulations[2].

Segmentation and Application

Dosage Forms

The lidocaine market is segmented into various dosage forms, including spray, gel/jelly, cream, ointment, lotion, patch, and pad. The ointment segment is expected to account for the largest revenue share due to its widespread use in pain relief and anti-itching applications[3].

Applications

Lidocaine is used in several applications, including:

• Ventricular Arrhythmias: Lidocaine injections are used to treat irregular heart rhythms.
• Anesthesia: Both injectable and topical forms are used in surgical procedures.
• Paracervical Block: Lidocaine is commonly used in outpatient gynecology procedures.
• Neuropathic Pain: Lidocaine is part of multimodal pain management strategies to reduce opioid use[3].

Distribution Channels

The market is segmented into online and offline distribution channels. The online distribution channel is expected to register the fastest CAGR due to greater customer accessibility and lower operating costs, especially post-COVID-19 pandemic[3].

Regional Insights

• North America: Holds the largest share in the local anesthesia drugs market due to a significant number of surgical procedures performed in the region[4].
• Asia Pacific: Expected to register the fastest CAGR of 6.7% during the forecast period, driven by an increase in dental and cosmetic surgeries, and innovations in surgical procedures[3].

Key Players

Major companies in the lidocaine and tetracaine markets include:

• Pfizer, Inc
• AstraZeneca Plc
• Glenmark Pharmaceuticals
• Teva Pharmaceutical Industries Ltd
• Viatris Inc.
• Amneal Pharmaceuticals LLC
• Taro Pharmaceuticals
• Aspen Pharmacare
• Fresenius Kabi
• Novartis, Inc.[3][4].

Financial Trajectory of Lidocaine

The lidocaine market was valued at USD 682.22 million in 2021 and is expected to reach USD 1,137.31 million by 2030, registering a CAGR of 5.8%[3].

Tetracaine Market Dynamics

While specific financial data for tetracaine is less detailed, it is often used in combination with lidocaine in formulations like lidocaine-tetracaine (LT) creams and gels. The efficacy and release rates of these combinations are critical for their market performance. For instance, emulgel formulations of LT have shown higher yield percentages and faster release rates compared to cream formulations[2].

Challenges and Considerations

• Toxicity and Safety: Topical anesthetics, including lidocaine, can have unpredictably high absorption levels in some individuals, highlighting the need for supervision by healthcare professionals to avoid adverse effects[5].
• Regulatory Approvals: Companies must navigate regulatory approvals, such as the FDA approval received by SunGen Pharma for Lidocaine Ointment USP, 5% in November 2019[3].

Key Takeaways

• The global local anesthesia drugs market, driven by lidocaine and tetracaine, is expected to grow significantly due to increasing surgical procedures and the aging population.
• Lidocaine dominates the market with a 28.7% share in 2023.
• Advancements in drug delivery systems and online distribution channels are key growth drivers.
• Major pharmaceutical companies are investing in product development and strategic alliances to gain a competitive edge.
• Regulatory and safety considerations are crucial for the continued growth of these markets.

FAQs

Q: What is the projected growth rate of the global local anesthesia drugs market? A: The global local anesthesia drugs market is projected to grow at a CAGR of 3.6% from 2024 to 2030[1][4].

Q: Which segment dominates the lidocaine market in terms of dosage form? A: The ointment segment is expected to account for the largest revenue share in the global lidocaine market over the forecast period[3].

Q: What are the primary applications of lidocaine? A: Lidocaine is used in various applications including ventricular arrhythmias, anesthesia, paracervical block, and neuropathic pain management[3].

Q: Which region is expected to register the fastest CAGR in the lidocaine market? A: The Asia Pacific region is expected to register the fastest CAGR of 6.7% during the forecast period[3].

Q: What are the potential risks associated with the use of topical lidocaine? A: Topical lidocaine can have unpredictably high absorption levels in some individuals, necessitating supervision by healthcare professionals to avoid adverse effects[5].

Cited Sources:

1. Grand View Research - Local Anesthesia Drugs Market Size & Share Report, 2030
2. Juniper Publishers - Preparation, Characterization, and In Vitro Evaluation of Cream and Gel Formulations of Lidocaine-Tetracaine Combination
3. Reports and Data - Lidocaine Market Size, Share, Growth, Trends & Forecasts To 2030
4. GlobeNewswire - Local Anesthesia Drugs Market Size, Share & Trends Analysis Report 2024-2030
5. Oxford Academic - Comparison of Five Commonly-Available, Lidocaine-Containing Topical Anesthetics