ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE - Generic Drug Details

What are the generic drug sources for articaine hydrochloride; epinephrine bitartrate and what is the scope of patent protection?

Articaine hydrochloride; epinephrine bitartrate is the generic ingredient in five branded drugs marketed by Hospira, Pierrel, Deproco, and Hansamed Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Eleven suppliers are listed for this compound.

Summary for ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

US Patents:	0
Tradenames:	5
Applicants:	4
NDAs:	5
Finished Product Suppliers / Packagers:	11
DailyMed Link:	ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE at DailyMed

Pharmacology for ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Drug Class	Amide Local Anesthetic Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists
Physiological Effect	Local Anesthesia

Anatomical Therapeutic Chemical (ATC) Classes for ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

A01AD	Other agents for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

B02BC	Local hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03AA	Alpha- and beta-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01EA	Sympathomimetics in glaucoma therapy
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Deproco	SEPTOCAINE	articaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	020971-002	Mar 30, 2006		RX	Yes	Yes
Deproco	SEPTOCAINE	articaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	020971-001	Apr 3, 2000		RX	Yes	Yes
Hospira	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	articaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	079138-001	Jun 18, 2010		DISCN	No	No
Hansamed Inc	ULTACAN FORTE	articaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	201750-001	Jul 11, 2017		DISCN	No	No
Pierrel	ORABLOC	articaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	022466-002	Feb 26, 2010		RX	Yes	Yes
Hansamed Inc	ULTACAN	articaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	201751-001	Jul 11, 2017		DISCN	No	No

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Articaine Hydrochloride and Epinephrine Bitartrate

Market Overview

The market for articaine hydrochloride, often combined with epinephrine bitartrate, is experiencing significant growth driven by several key factors. Here are the critical aspects shaping the market dynamics and financial trajectory of this drug.

Market Size and Growth

As of 2022, the articaine hydrochloride market was valued at USD 1,128.33 million. It is projected to grow from USD 1,221.99 million in 2023 to USD 2,135.33 million by 2031, with a Compound Annual Growth Rate (CAGR) of 8.3% during the forecast period (2024-2031)[1].

Regional Dominance

• North America: This region holds the largest share of the articaine hydrochloride market, primarily due to the growing awareness and demand for corrective and preventive dental treatments in the U.S. and Canada[3].
• Europe: Europe is another significant market, driven by rising dental treatment needs and the increasing adoption of preventative and remedial treatments[1].
• Asia-Pacific: Countries like China, Japan, and India are driving the rapid growth in this region, with Australia also playing a crucial role due to its high adoption of new dental technologies[1][3].

Market Drivers

Effective Dental Treatments

Articaine hydrochloride is preferred by dentists due to its rapid action, superior efficacy, and ability to penetrate soft tissues and bone effectively. This is particularly beneficial in cases where other anesthetics like lidocaine may not be as effective, such as in patients with hypokalemic sensory overstimulation[1].

Rising Incidence of Dental Problems

The increasing incidence of dental caries and periodontal diseases, exacerbated by factors like junk food consumption and an aging population, is driving the demand for articaine hydrochloride[1][3].

Growing Disposable Income and Cosmetic Dentistry

The rise in disposable income and the growing trend of cosmetic dentistry are additional factors supporting market expansion[1].

Advances in Pharmaceutical Delivery Technology

The use of computer-controlled local anesthetic delivery (CCLAD) systems and other technological advancements have improved patient tolerance and efficacy, further boosting the market[1].

Market Restraints

Regulatory and Cost Challenges

Despite the growth drivers, the market faces challenges such as unfavorable reimbursement regulations and the high cost of dental procedures. These factors are expected to impede market expansion to some extent[1].

Availability of Substitute Products

The availability and use of substitute local anesthetics like lidocaine, prilocaine, mepivacaine, and bupivacaine could also hinder the growth of the articaine hydrochloride market[1].

Pharmacological Profile

Mechanism of Action

Articaine hydrochloride works by blocking the conduction of painful sensations by diminishing the sodium ion influx during the action potential period. When combined with epinephrine, it acts as a vasoconstrictor, prolonging the duration of anesthesia[2].

Clinical Use

It is indicated for infiltration anesthesia and nerve block anesthesia in clinical dentistry, suitable for various dental procedures such as extractions, trephinement, apical resections, and maxillo-facial surgery[2].

Key Players and Competitive Landscape

Major pharmaceutical companies like Septodont, Dentsply Sirona, Pierrel Pharma, 3M Company, and Anhui BBCA Pharmaceutical Co., Ltd. are actively involved in product innovation, strategic partnerships, and geographical expansion to capture market share. These companies are also focusing on expanding their production capacity and introducing alternative products to address the dentistry sector[1].

Research and Development

Ongoing research and development efforts are crucial for the market's growth. For instance, studies on articaine-loaded poly(ε-caprolactone) nanocapsules have shown promising results in reducing toxicity and increasing the analgesic efficacy of articaine[4].

End-User Segmentation

The market is segmented by end-users such as dental clinics, hospitals, and ambulatory surgical centers. Dental clinics are the largest segment, while hospitals are expected to be the fastest-growing segment[1].

Geographical Expansion

The market is expanding globally, with significant growth potential in regions like Latin America, the Middle East, and Africa. These regions are driven by increasing dental procedures, expansion of the healthcare system, rising disposable income, and growing awareness of modern dental anesthesia techniques[1].

Key Takeaways

• The articaine hydrochloride market is projected to grow significantly, driven by its efficacy and the rising incidence of dental problems.
• North America and Europe are dominant regions, with Asia-Pacific showing rapid growth.
• Advances in pharmaceutical delivery technology and growing disposable income are key drivers.
• Regulatory challenges and the availability of substitute products are potential restraints.
• Ongoing R&D and geographical expansion are crucial for market growth.

FAQs

1. What is the current market size of articaine hydrochloride?

As of 2022, the articaine hydrochloride market was valued at USD 1,128.33 million[1].

2. What is the projected growth rate of the articaine hydrochloride market?

The market is projected to grow at a CAGR of 8.3% from 2024 to 2031[1].

3. Which regions dominate the articaine hydrochloride market?

North America and Europe are the dominant regions, with Asia-Pacific showing significant growth[1][3].

4. What are the main drivers of the articaine hydrochloride market?

The main drivers include the drug's efficacy, rising incidence of dental problems, advances in pharmaceutical delivery technology, and growing disposable income[1].

5. What are the potential restraints for the articaine hydrochloride market?

Potential restraints include unfavorable reimbursement regulations, high cost of dental procedures, and the availability of substitute local anesthetics[1].

Sources:

1. SkyQuest Market Research: Articaine Hydrochloride Market Size, Growth & Trends Report | 2031[1].
2. Health Canada: Articaine Hydrochloride and Epinephrine Bitartrate Injection[2].
3. Transparency Market Research: Articaine Hydrochloride Market Size, Share | Industry Sales - 2034[3].
4. PLOS ONE: Promising potential of articaine-loaded poly(epsilon-caprolactone) nanocapsules for local or topical anesthesia in dentistry[4].