Chloroprocaine hydrochloride - Generic Drug Details

What are the generic drug sources for chloroprocaine hydrochloride and what is the scope of freedom to operate?

Chloroprocaine hydrochloride is the generic ingredient in five branded drugs marketed by Harrow Eye, Hikma, Hospira, Fresenius Kabi Usa, and B Braun Medical Inc, and is included in six NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Chloroprocaine hydrochloride has fifty-three patent family members in thirty-six countries.

There are two drug master file entries for chloroprocaine hydrochloride. Six suppliers are listed for this compound.

Summary for chloroprocaine hydrochloride

International Patents:	53
US Patents:	3
Tradenames:	5
Applicants:	5
NDAs:	6
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	35
Patent Applications:	1,196
What excipients (inactive ingredients) are in chloroprocaine hydrochloride?	chloroprocaine hydrochloride excipients list
DailyMed Link:	chloroprocaine hydrochloride at DailyMed

Recent Clinical Trials for chloroprocaine hydrochloride

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

Sponsor	Phase
Johns Hopkins University	Phase 3
Sintetica SA	Phase 2/Phase 3
Sintetica SA	Phase 1/Phase 2

See all chloroprocaine hydrochloride clinical trials

Pharmacology for chloroprocaine hydrochloride

Drug Class	Ester Local Anesthetic
Physiological Effect	Local Anesthesia

Anatomical Therapeutic Chemical (ATC) Classes for chloroprocaine hydrochloride

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

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

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

S01HA	Local anesthetics
S01H	LOCAL ANESTHETICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01HA	Local anesthetics
S01H	LOCAL ANESTHETICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for chloroprocaine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
B Braun Medical Inc	CLOROTEKAL	chloroprocaine hydrochloride	SOLUTION;INTRATHECAL	208791-001	Sep 26, 2017		DISCN	Yes	No	9,504,666		Y
Hikma	CHLOROPROCAINE HYDROCHLORIDE	chloroprocaine hydrochloride	INJECTABLE;INJECTION	040273-002	Sep 9, 1998	AP	RX	No	No
B Braun Medical Inc	CLOROTEKAL	chloroprocaine hydrochloride	SOLUTION;INTRATHECAL	208791-001	Sep 26, 2017		DISCN	Yes	No	8,969,412		Y
Hospira	CHLOROPROCAINE HYDROCHLORIDE	chloroprocaine hydrochloride	INJECTABLE;INJECTION	087447-001	Apr 16, 1982		DISCN	No	No
Harrow Eye	IHEEZO	chloroprocaine hydrochloride	GEL;OPHTHALMIC	216227-001	Sep 27, 2022		RX	Yes	Yes	10,792,271		Y
Fresenius Kabi Usa	NESACAINE	chloroprocaine hydrochloride	INJECTABLE;INJECTION	009435-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

International Patents for chloroprocaine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Israel	273213	תכשירים מקומיים של כלורופרוקאין (Topical formulations of chloroprocaine)
European Patent Office	3681473	FORMULATIONS TOPIQUES DE CHLOROPROCAÏNE (TOPICAL FORMULATIONS OF CHLOROPROCAINE)
Canada	3070336	FORMULATIONS TOPIQUES DE CHLOROPROCAINE ET METHODES D'UTILISATION (TOPICAL FORMULATIONS OF CHLOROPROCAINE AND METHODS OF USING SAME)
Peru	20201281	FORMULACIONES TOPICAS DE CLOROPROCAINA Y METODOS PARA UTILIZAR LAS MISMAS
Ecuador	SP20022313	FORMULACIONES TÓPICAS DE CLOROPROCAÍNA Y MÉTODOS PARA UTILIZAR LAS MISMAS
Argentina	099443	COMPOSICIÓN FARMACÉUTICA A BASE DE CLOROPROCAÍNA PARA LA ADMINISTRACIÓN INTRATECAL REPETIDA

Chloroprocaine hydrochloride Market Analysis and Financial Projection Experimental

Chloroprocaine Hydrochloride: Market Dynamics and Financial Trajectory

Introduction

Chloroprocaine hydrochloride is a local anesthetic agent widely used in various medical procedures, including nerve blocks, infiltration, and epidural anesthesia. Its market dynamics and financial trajectory are influenced by several factors, including clinical indications, market trends, and regulatory approvals.

Clinical Indications and Uses

Chloroprocaine hydrochloride is indicated for the production of local anesthesia through infiltration, peripheral and central nerve block, and lumbar and caudal epidural blocks. It is also approved for ocular surface anesthesia, particularly in procedures like cataract surgery[1][3].

Market Size and Growth

The global market for chloroprocaine hydrochloride is part of the broader local anesthesia drugs market. As of 2021, the global local anesthesia drugs market was valued at $2,643.50 million and is projected to grow at a Compound Annual Growth Rate (CAGR) of 6.4%, reaching $4,724.80 million by 2031[4].

Specifically, the global chloroprocaine hydrochloride injection market was valued at USD 1,473.39 million in 2024 and is expected to reach USD 2,798.92 million by 2031, indicating a significant growth trajectory[5].

Drivers of Market Growth

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

Increasing Prevalence of Chronic Diseases

The rising incidence of chronic diseases such as cancer and tumors, which often require painful surgical procedures, has increased the demand for local anesthesia. Chloroprocaine hydrochloride, with its rapid onset and short duration of action, is particularly beneficial in these scenarios[4].

Advancements in Medical Procedures

The introduction of new and effective medications, along with advancements in surgical techniques, has expanded the use of local anesthetics. For instance, the approval of chloroprocaine hydrochloride ophthalmic gel for ocular surface anesthesia has opened new avenues for its application[2].

Regulatory Approvals and Reimbursement

Recent regulatory approvals, such as the FDA approval of chloroprocaine hydrochloride ophthalmic gel in September 2022 and the transitional pass-through reimbursement status granted by CMS, have enhanced the market accessibility and affordability of this drug. This reimbursement status allows for separate reimbursement by Medicare, making the drug more attractive to healthcare providers[2].

Increasing Healthcare Spending

Rising healthcare spending in developing countries, such as India and Brazil, where the number of surgeries is increasing, is also driving the demand for local anesthesia drugs, including chloroprocaine hydrochloride[4].

Market Segmentation

The market for chloroprocaine hydrochloride can be segmented based on application and region:

Application

• Injectable Anesthetics: Used in nerve blocks, infiltration, and epidural anesthesia.
• Surface Anesthetics: Used for ocular surface anesthesia, particularly in ophthalmic procedures[1][3].

Regional Analysis

• North America: Currently the most dominant region in the local anesthesia drugs market, driven by advanced healthcare infrastructure and high adoption rates of new medical technologies.
• Europe, Asia-Pacific, and LAMEA: These regions are also experiencing growth due to increasing healthcare spending and the rising prevalence of chronic diseases[4].

Financial Trajectory

The financial trajectory of chloroprocaine hydrochloride is positive, with significant growth projected over the next few years. Here are some key financial highlights:

• Market Size: The global chloroprocaine hydrochloride injection market is expected to grow from USD 1,473.39 million in 2024 to USD 2,798.92 million by 2031[5].
• Revenue Growth: This represents a substantial increase, driven by the factors mentioned above.
• Reimbursement: The transitional pass-through reimbursement status granted by CMS will further boost the financial viability of the drug by ensuring separate reimbursement by Medicare[2].

Challenges and Considerations

While the market for chloroprocaine hydrochloride is growing, there are several challenges and considerations:

Safety and Side Effects

Chloroprocaine hydrochloride can cause allergic reactions, particularly in individuals with sulfite sensitivity. It also has potential systemic toxicity effects, although these are generally minimal due to its rapid metabolism[1][3].

Competition

The local anesthesia market is competitive, with other drugs like lidocaine, bupivacaine, and ropivacaine also widely used. However, chloroprocaine hydrochloride's unique pharmacological profile, including its short latency and duration, positions it favorably in certain clinical scenarios[3].

Regulatory Environment

Changes in regulatory policies and reimbursement structures can impact the market dynamics. However, recent approvals and reimbursement statuses have been favorable for chloroprocaine hydrochloride[2].

Key Takeaways

• Chloroprocaine hydrochloride is a versatile local anesthetic with applications in various medical procedures.
• The market for this drug is driven by the increasing prevalence of chronic diseases, advancements in medical procedures, and favorable regulatory approvals.
• The global market is projected to grow significantly, with the chloroprocaine hydrochloride injection market expected to reach USD 2,798.92 million by 2031.
• Despite challenges, the drug's unique pharmacological profile and recent regulatory approvals position it for continued growth.

FAQs

What are the primary indications for chloroprocaine hydrochloride?

Chloroprocaine hydrochloride is indicated for the production of local anesthesia through infiltration, peripheral and central nerve block, and lumbar and caudal epidural blocks. It is also used for ocular surface anesthesia.

How does chloroprocaine hydrochloride work?

Chloroprocaine hydrochloride works by binding to the alpha subunit on the cytoplasmic region of voltage-gated sodium channels, inhibiting sodium influx in neuronal cell membranes, and thus blocking nerve conduction.

What are the potential side effects of chloroprocaine hydrochloride?

Potential side effects include allergic reactions, particularly in individuals with sulfite sensitivity, and systemic toxicity effects such as central nervous system stimulation or depression.

What is the projected market size for chloroprocaine hydrochloride by 2031?

The global chloroprocaine hydrochloride injection market is expected to reach USD 2,798.92 million by 2031.

Has chloroprocaine hydrochloride received any recent regulatory approvals?

Yes, chloroprocaine hydrochloride ophthalmic gel 3% received FDA approval in September 2022 and was granted transitional pass-through reimbursement status by CMS.

Sources

1. Pfizer Labeling: Chloroprocaine Hydrochloride Injection, USP.
2. Ophthalmology Times: Harrow Announces Transitional Pass-Through Reimbursement Status for Chloroprocaine Hydrochloride Ophthalmic Gel 3%.
3. DrugBank: Chloroprocaine: Uses, Interactions, Mechanism of Action.
4. Research Dive: Local Anesthesia Drugs Market Size & Industry Trends: 2031.
5. Proficient Market Insights: Global Chloroprocaine Hydrochloride Injection Market Research.