BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE - Generic Drug Details

What are the generic drug sources for bupivacaine hydrochloride; epinephrine bitartrate and what is the scope of freedom to operate?

Bupivacaine hydrochloride; epinephrine bitartrate is the generic ingredient in five branded drugs marketed by Hospira, Fresenius Kabi Usa, and Septodont, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

US Patents:	0
Tradenames:	5
Applicants:	3
NDAs:	7
Finished Product Suppliers / Packagers:	6
Clinical Trials:	2
DailyMed Link:	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE at DailyMed

Recent Clinical Trials for BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

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

Sponsor	Phase
Sunnybrook Health Sciences Centre	N/A
Cosmozone Dental Clinic	N/A

See all BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE clinical trials

Pharmacology for BUPIVACAINE 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 BUPIVACAINE 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 BUPIVACAINE 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
Hospira	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	016964-013	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Hospira	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	016964-007	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Hospira	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	022046-001	Jul 13, 1983		DISCN	Yes	No
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	070966-001	Oct 13, 1987	AP	RX	No	No
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	070968-001	Oct 13, 1987	AP	RX	No	No

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bupivacaine Hydrochloride; Epinephrine Bitartrate

Introduction

Bupivacaine hydrochloride, often combined with epinephrine bitartrate, is a widely used local anesthetic in various medical and dental procedures. This article delves into the market dynamics and financial trajectory of this drug, highlighting key drivers, market segmentation, and future projections.

Market Size and Growth

The global bupivacaine injection market, which includes bupivacaine hydrochloride with and without epinephrine, had a market share of USD 721.68 million in 2017. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.6% from 2020 to 2030, reaching an estimated USD 1447 million by 2030[1].

Key Drivers

Several factors are driving the growth of the bupivacaine injection market:

Increasing Older Population and Chronic Diseases

The rise in the older population suffering from chronic diseases has led to an increase in surgical procedures, which in turn has boosted the demand for bupivacaine injections[1].

Growth in Surgical Procedures

The increase in various types of surgeries, including dental and obstetrical procedures, has significantly contributed to the market growth. Bupivacaine is widely used to provide local or regional anesthesia for these procedures[1].

COVID-19 Impact

During the COVID-19 pandemic, there was a temporary disruption in the market due to restrictions on non-emergent surgical operations. However, the use of local anesthesia like bupivacaine gained popularity due to its benefits and low risk of viral transmission. This has positively impacted the market during the forecast period[1].

Market Segmentation

The bupivacaine injection market is segmented based on several criteria:

By Type

The market is segmented into different concentrations of bupivacaine, including 0.25%, 0.5%, and 0.75%. The 0.25% bupivacaine injection sub-segment is expected to be the most profitable during the forecast period due to its widespread use in various medical and dental procedures[1].

By Distribution Channel

The market is segmented into hospitals, clinics, and other distribution channels. Hospitals are a major segment due to the high volume of surgical procedures performed in these settings[1].

By Region

North America is expected to dominate the global bupivacaine injection market due to the expanding patient population and the rise in medical and dental surgical procedures. The Asia-Pacific (APAC) region is also registering significant growth during the forecasted period[1].

Competitive Landscape

The bupivacaine injection market is highly competitive with several key players:

• Pfizer
• Baxter
• Fresenius Kabi
• AstraZeneca
• Other notable manufacturers

These companies are continuously innovating and expanding their product portfolios to capture a larger market share[1].

Financial Projections

The financial trajectory of the bupivacaine injection market is promising, with significant growth expected over the next decade. Here are some key financial projections:

• Market Size: Expected to reach USD 1447 million by 2030[1].
• CAGR: Projected to grow at a CAGR of 5.6% from 2020 to 2030[1].
• Revenue Streams: The primary revenue streams come from hospital and clinic sales, with a growing contribution from other distribution channels[1].

Usage and Applications

Bupivacaine hydrochloride with epinephrine bitartrate is used in a variety of applications:

• Local or Regional Anesthesia: It is used to numb a specific part of the body before, during, or after surgery, childbirth, or dental work[1][2][4].
• Surgical Procedures: It is commonly used for lower abdominal surgery, including cesarean sections, urological procedures, and hip surgeries[1][2][4].
• Obstetrical Procedures: It is used for labor discomfort and other obstetrical procedures[1].

Pharmacokinetics and Safety

Bupivacaine hydrochloride works by stabilizing the neuronal membrane and preventing the initiation and transmission of nerve impulses. However, it can have systemic effects, particularly on the cardiovascular and central nervous systems, if absorbed in toxic concentrations. The presence of epinephrine can reduce the rate of absorption and peak plasma concentration, allowing for larger doses and prolonged action[2][3][5].

Challenges and Opportunities

Despite the positive growth trajectory, the market faces several challenges:

• Regulatory Hurdles: Strict regulatory requirements and the need for continuous compliance can be challenging for manufacturers[2][3][5].
• Side Effects and Toxicity: The risk of systemic toxicity, particularly cardiac and CNS effects, requires careful dosing and monitoring[2][3][5].

However, there are also opportunities for growth:

• Innovative Formulations: Developing new formulations with improved safety profiles and longer durations of action can capture additional market share.
• Emerging Markets: Expanding into emerging markets, particularly in the APAC region, can provide significant growth opportunities[1].

Key Takeaways

• The global bupivacaine injection market is projected to grow significantly, driven by an increase in surgical procedures and the aging population.
• The 0.25% bupivacaine injection segment is expected to dominate the market.
• North America and the APAC region are key markets, with North America leading and the APAC region showing the highest growth.
• The market is competitive, with major players like Pfizer, Baxter, and Fresenius Kabi.
• Bupivacaine hydrochloride with epinephrine bitartrate is widely used in various medical and dental procedures due to its efficacy and safety profile.

FAQs

What is the projected market size of the bupivacaine injection market by 2030?

The global bupivacaine injection market is expected to reach USD 1447 million by 2030[1].

Which region is expected to dominate the bupivacaine injection market?

North America is expected to dominate the global bupivacaine injection market, although the APAC region is registering the highest growth[1].

What are the primary applications of bupivacaine hydrochloride with epinephrine bitartrate?

It is used for local or regional anesthesia in surgical, diagnostic, therapeutic, and obstetrical procedures[1][2][4].

How does the presence of epinephrine affect bupivacaine hydrochloride?

The presence of epinephrine reduces the rate of absorption and peak plasma concentration of bupivacaine, allowing for larger doses and prolonged action[2][3][5].

What are the potential side effects of bupivacaine hydrochloride?

Systemic absorption can lead to cardiovascular and CNS effects, including cardiac conduction depression, ventricular arrhythmias, and CNS stimulation or depression[2][3][5].

Sources

1. Globenewswire: Bupivacaine Injection Market to Reach USD 1447 Million by 2030[1].
2. FDA Labeling: Marcaine Bupivacaine Hydrochloride injection label[2].
3. Pfizer Labeling: Bupivacaine Hydrochloride Injection, USP[3].
4. DailyMed: MARCAINE- bupivacaine hydrochloride and epinephrine bitartrate[4].
5. FDA Labeling: Bupivacaine - accessdata.fda.gov[5].