TETRACAINE HYDROCHLORIDE - Generic Drug Details

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

Tetracaine hydrochloride is the generic ingredient in one branded drug marketed by Alcon Labs and Bausch Lomb Ireland, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for tetracaine hydrochloride. Six suppliers are listed for this compound.

Summary for TETRACAINE HYDROCHLORIDE

US Patents:	0
Tradenames:	1
Applicants:	2
NDAs:	2
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	96
Patent Applications:	4,415
What excipients (inactive ingredients) are in TETRACAINE HYDROCHLORIDE?	TETRACAINE HYDROCHLORIDE excipients list
DailyMed Link:	TETRACAINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for TETRACAINE HYDROCHLORIDE

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

Sponsor	Phase
Vance Thompson Vision	Early Phase 1
Juerg Hafner	Phase 2
Cutia Therapeutics（Wuxi）Co.,Ltd	Phase 3

See all TETRACAINE HYDROCHLORIDE clinical trials

Pharmacology for TETRACAINE HYDROCHLORIDE

Drug Class	Ester Local Anesthetic
Physiological Effect	Local Anesthesia

Medical Subject Heading (MeSH) Categories for TETRACAINE HYDROCHLORIDE

Anesthetics, Local

Anatomical Therapeutic Chemical (ATC) Classes for TETRACAINE HYDROCHLORIDE

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

N01BA	Esters of aminobenzoic acid
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

S01HA	Local anesthetics
S01H	LOCAL ANESTHETICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for TETRACAINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon Labs	TETRACAINE HYDROCHLORIDE	tetracaine hydrochloride	SOLUTION;OPHTHALMIC	208135-001	Feb 29, 2016		RX	Yes	Yes
Bausch Lomb Ireland	TETRACAINE HYDROCHLORIDE	tetracaine hydrochloride	SOLUTION;OPHTHALMIC	210821-001	Mar 12, 2019		RX	Yes	Yes

TETRACAINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Tetracaine Hydrochloride: Market Dynamics and Financial Trajectory

Introduction

Tetracaine hydrochloride, a potent local anesthetic, has been a staple in medical procedures for decades, particularly in ophthalmology and other surgical fields. This article delves into the market dynamics and financial trajectory of tetracaine hydrochloride, highlighting its current status, future projections, and key factors influencing its market.

Market Size and Forecast

The global market for tetracaine hydrochloride is anticipated to experience significant growth. As of 2023, the market was estimated to be worth approximately $86 million and is forecast to reach $121.3 million by the end of the forecast period[4].

Growth Drivers

Several factors are driving the growth of the tetracaine hydrochloride market:

Increasing Surgical Procedures

The rise in the number of surgical procedures, including general surgeries, plastic surgeries, and cosmetic surgeries, is a major driver. Local anesthetics like tetracaine hydrochloride are in high demand due to their efficacy in pain management during and after these procedures[3].

Advancements in Pain Management

The use of topical anesthetics such as tetracaine hydrochloride has significantly improved pain control in patients undergoing procedures like PRK (Photorefractive Keratectomy). This has made PRK more acceptable to patients, contributing to the market growth[2].

COVID-19 Impact

The COVID-19 pandemic has highlighted the importance of local anesthetics in reducing the risk of viral transmission during medical procedures. This has further boosted the demand for tetracaine hydrochloride[3].

Market Segmentation

The market for tetracaine hydrochloride can be segmented based on several criteria:

By Application

• General Surgeries: Tetracaine hydrochloride is widely used in general surgeries for its rapid and short-acting anesthetic properties.
• Ophthalmic Procedures: It is particularly popular in ophthalmology for procedures requiring topical anesthesia.
• Plastic and Cosmetic Surgeries: Its use extends to plastic and cosmetic surgeries where local anesthesia is necessary[3].

By Route of Administration

• Topical: The most common route for tetracaine hydrochloride, especially in ophthalmic and dermatologic applications.
• Other Routes: Though less common, it can be administered through other routes depending on the procedure[3].

By End User

• Hospitals: Major consumers of tetracaine hydrochloride due to the high volume of surgical procedures.
• Ambulatory Surgical Centers: These centers also use tetracaine hydrochloride frequently for outpatient procedures[3].

Regional Market Analysis

The market for tetracaine hydrochloride is segmented into several regions:

• North America: A significant market due to advanced healthcare infrastructure and high demand for surgical procedures.
• Europe: Another major market with a strong presence of pharmaceutical companies.
• Asia Pacific: Growing rapidly due to increasing healthcare spending and a large patient population.
• Latin America and Middle East & Africa: These regions are also experiencing growth, driven by improving healthcare systems and increasing demand for surgical services[3].

Key Players

The market for tetracaine hydrochloride is dominated by several key players:

• Alcon Laboratories, Inc.: A major manufacturer of tetracaine hydrochloride ophthalmic solutions.
• Fresenius SE & Co. KGaA: Known for its comprehensive range of pharmaceutical products, including local anesthetics.
• Hikma Pharmaceuticals: Another significant player in the local anesthetics market.
• Pfizer Inc.: A global pharmaceutical giant with a diverse portfolio that includes local anesthetics[3].

Regulatory Status

Tetracaine hydrochloride ophthalmic solutions have been marketed in the U.S. for over 45 years, although they have the status of “unapproved drug” by the FDA. Recent regulatory activities, including pre-IND meetings and NDA submissions, are aimed at formalizing its approval status[5].

Safety and Efficacy

The safety and efficacy of tetracaine hydrochloride have been well-documented. It is known for its rapid and short-acting anesthetic properties, making it ideal for various ophthalmic procedures. The FDA clinical review highlights that the benefit-risk profile of tetracaine 0.5% supports its use as a topical ophthalmic anesthetic, with adverse events being non-serious and mostly related to pain/discomfort upon instillation[5].

Financial Projections

The financial trajectory of tetracaine hydrochloride is promising, with a projected growth rate that reflects the increasing demand for local anesthetics. Here are some key financial projections:

• Market Value: Expected to grow from $86 million in 2023 to $121.3 million by the end of the forecast period[4].
• CAGR: The local anesthetics market, which includes tetracaine hydrochloride, is anticipated to register a CAGR of 4.2% from 2022 to 2032[3].

Conclusion

Tetracaine hydrochloride is poised for significant growth driven by its efficacy in pain management, increasing surgical procedures, and the COVID-19 pandemic's impact on healthcare practices. With a strong market presence and favorable regulatory outlook, tetracaine hydrochloride is set to continue its upward trajectory.

Key Takeaways

• Market Growth: The global market for tetracaine hydrochloride is expected to reach $121.3 million by the end of the forecast period.
• Growth Drivers: Increasing surgical procedures, advancements in pain management, and the COVID-19 pandemic are key drivers.
• Regulatory Status: Tetracaine hydrochloride ophthalmic solutions are currently unapproved by the FDA but have a long history of safe use.
• Safety and Efficacy: Well-documented safety and efficacy profile with minimal adverse events.
• Financial Projections: Anticipated CAGR of 4.2% for the local anesthetics market.

FAQs

What is the current market size of tetracaine hydrochloride?

The global market for tetracaine hydrochloride was estimated to be worth approximately $86 million in 2023[4].

What are the primary applications of tetracaine hydrochloride?

Tetracaine hydrochloride is primarily used in ophthalmic procedures, general surgeries, and plastic and cosmetic surgeries[3].

Who are the key players in the tetracaine hydrochloride market?

Key players include Alcon Laboratories, Inc., Fresenius SE & Co. KGaA, Hikma Pharmaceuticals, and Pfizer Inc.[3].

What is the regulatory status of tetracaine hydrochloride ophthalmic solutions in the U.S.?

Tetracaine hydrochloride ophthalmic solutions have the status of “unapproved drug” by the FDA but have been marketed for over 45 years[5].

What is the projected growth rate for the tetracaine hydrochloride market?

The local anesthetics market, which includes tetracaine hydrochloride, is anticipated to register a CAGR of 4.2% from 2022 to 2032[3].

Sources

1. Market Research Intellect: Tetracaine Hydrochloride API Market Size, Scope And Forecast Report.
2. CRSToday: Tetracaine for Post-PRK Patients.
3. GlobeNewswire: Local Anesthesia Drugs Market is estimated to be US$ 8.5 billion by 2032.
4. Valuates Reports: Tetracaine Hydrochloride - Market, Report Size, Worth, Revenue.
5. FDA: 202123 Tetracaine Clinical PREA.