Bupivacaine hydrochloride; epinephrine - Generic Drug Details

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

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

Two suppliers are listed for this compound.

Summary for bupivacaine hydrochloride; epinephrine

US Patents:	0
Tradenames:	5
Applicants:	3
NDAs:	14
Finished Product Suppliers / Packagers:	2
Clinical Trials:	167
DailyMed Link:	bupivacaine hydrochloride; epinephrine at DailyMed

Recent Clinical Trials for bupivacaine hydrochloride; epinephrine

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

Sponsor	Phase
Montefiore Medical Center	N/A
University Hospital "Sestre Milosrdnice"	N/A
Jessyka Lighthall	Phase 3

See all bupivacaine hydrochloride; epinephrine clinical trials

Pharmacology for bupivacaine hydrochloride; epinephrine

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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	070967-001	Oct 13, 1987	AP	RX	No	No
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	070966-001	Oct 13, 1987	AP	RX	No	No
Hospira	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	bupivacaine hydrochloride; epinephrine	INJECTABLE;INJECTION	071168-001	Jun 16, 1988	AP	RX	No	Yes

Bupivacaine hydrochloride; epinephrine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Bupivacaine Hydrochloride with Epinephrine

Introduction to Bupivacaine Hydrochloride with Epinephrine

Bupivacaine hydrochloride, often combined with epinephrine, is a widely used local anesthetic that provides effective pain relief for various surgical, diagnostic, therapeutic, and obstetrical procedures. Here, we delve into the market dynamics and financial trajectory of this essential medical product.

Market Size and Growth

The global bupivacaine injection market has been experiencing significant growth. As of 2017, the market size was approximately USD 721.68 million, and it is predicted to increase at a Compound Annual Growth Rate (CAGR) of 5.6% from 2020 to 2030, reaching USD 1447 million by 2030[3].

Segmentation of the Market

The bupivacaine injection market is segmented by type, distribution channel, and region.

By Type

• The market is divided into 0.25%, 0.5%, and 0.75% concentrations. The 0.25% segment is expected to be the most profitable during the forecast period due to its widespread use in various medical procedures[3].

By Distribution Channel

• The market is distributed through hospitals, clinics, and other channels. Hospitals are a major segment due to the high volume of surgical and diagnostic procedures performed in these settings[3].

By Region

• North America is expected to dominate the global market due to an expanding patient population and an increase in medical and dental surgical procedures. The Asia-Pacific (APAC) region is also experiencing high growth during the forecasted period[3].

Key Drivers of the Market

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

Rise in Chronic Diseases and Surgical Procedures

• An increase in the older population suffering from chronic diseases and the growth in various types of surgeries are significant drivers. Bupivacaine is used to numb specific parts of the body before, during, or after surgery, childbirth, or dental work[3].

Benefits During the COVID-19 Pandemic

• The COVID-19 pandemic has highlighted the importance of local anesthesia, as it reduces the risk of viral transmission. Bupivacaine has been used to minimize viral inoculum sampling in COVID-19 suspects, contributing to its increased popularity during this period[3].

Financial Aspects

Revenue and Sales

• In the US, sales of bupivacaine HCl injection (0.25%, 0.5%, and 0.75% in 10mL and 30mL doses) were approximately $64 million in the 12 months ending October 2021[1].

Pricing

• The cost of bupivacaine/epinephrine injections varies based on concentration and quantity. For example, a 0.25%-1:200,000 preservative-free solution can cost around $54.94 for 100 milliliters, while a 0.5%-1:200,000 solution can cost around $36.50 for 100 milliliters[4].

Market Players

The bupivacaine injection market is saturated with several key players:

Major Manufacturers

• Companies like Pfizer, Baxter, Fresenius Kabi, and AstraZeneca are prominent in the market. Hikma Pharmaceuticals, for instance, is the second largest US supplier of generic injectable medicines by volume and has a growing portfolio of over 120 products[1][3].

Dosage and Administration

Bupivacaine hydrochloride with epinephrine is administered in various concentrations and dosages depending on the procedure:

Concentrations and Dosages

• The common concentrations are 0.25%, 0.5%, and 0.75%. For example, the 0.5% solution with epinephrine can be used for infiltration and block injections, with dosages ranging from 5-45 mg without epinephrine and up to 225 mg with epinephrine[2].

Clinical Uses

Bupivacaine hydrochloride with epinephrine is versatile in its clinical applications:

Surgical Procedures

• It is used for local or regional anesthesia in surgeries, including lower abdominal surgery, urological procedures, and hip surgery[3].

Obstetrical Procedures

• It is commonly used in obstetrical procedures, such as cesarean sections, providing anesthesia lasting 1.5-3 hours[3].

Dental and Diagnostic Procedures

• It is also used in dental and oral surgery procedures, as well as diagnostic and therapeutic procedures[1].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the bupivacaine injection market:

Initial Disruptions

• There were severe disruptions in commodity demand and global supply networks, leading to an overstock problem in the medical device business. Non-emergent surgical operations were put on hold, affecting demand[3].

Long-term Benefits

• However, the pandemic highlighted the benefits of local anesthesia, such as reduced risk of viral transmission. This has led to increased popularity and usage of bupivacaine injections during the pandemic period[3].

Key Takeaways

• The global bupivacaine injection market is expected to grow significantly, reaching USD 1447 million by 2030.
• The 0.25% concentration segment is expected to be the most profitable.
• North America and the APAC region are key markets.
• The COVID-19 pandemic has positively impacted the market due to the benefits of local anesthesia.
• Major players include Pfizer, Baxter, Fresenius Kabi, and Hikma Pharmaceuticals.

FAQs

1. What are the common concentrations of bupivacaine hydrochloride injections?

• The common concentrations are 0.25%, 0.5%, and 0.75%[1][3].

2. How is bupivacaine hydrochloride with epinephrine used in surgical procedures?

• It is used for local or regional anesthesia in various surgeries, including lower abdominal surgery, urological procedures, and hip surgery[3].

3. What is the expected market size of the bupivacaine injection market by 2030?

• The market is expected to reach USD 1447 million by 2030[3].

4. How did the COVID-19 pandemic affect the bupivacaine injection market?

• Initially, there were disruptions in supply and demand, but the pandemic ultimately highlighted the benefits of local anesthesia, leading to increased usage[3].

5. Who are the major players in the bupivacaine injection market?

• Major players include Pfizer, Baxter, Fresenius Kabi, AstraZeneca, and Hikma Pharmaceuticals[1][3].

Cited Sources

1. Hikma Pharmaceuticals PLC. "Hikma launches Bupivacaine HCl Injection, USP." Press Release, December 20, 2021.
2. Pfizer Medical Information. "Bupivacaine Hydrochloride and Epinephrine Injection 0.5% (5 mg/mL)."
3. GlobeNewswire. "Bupivacaine Injection Market to Reach USD 1447 Million by 2030." April 8, 2022.
4. Drugs.com. "Bupivacaine/epinephrine Prices, Coupons, Copay Cards & Patient Assistance."