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:	185
DailyMed Link:	bupivacaine hydrochloride; epinephrine at DailyMed

Recent Clinical Trials for bupivacaine hydrochloride; epinephrine

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

Sponsor	Phase
Wake Forest University Health Sciences	PHASE4
Mount Sinai Hospital, Canada	PHASE2
University of Toronto	PHASE3

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
Hospira	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	bupivacaine hydrochloride; epinephrine	INJECTABLE;INJECTION	071170-001	Jun 16, 1988	AP	RX	No	No
Hospira	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	bupivacaine hydrochloride; epinephrine	INJECTABLE;INJECTION	071166-001	Jun 16, 1988		DISCN	No	No
Hospira	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	016964-004	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Hospira	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	bupivacaine hydrochloride; epinephrine	INJECTABLE;INJECTION	071167-001	Jun 16, 1988		RX	No	No
Hospira	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	016964-010	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
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	070968-001	Oct 13, 1987	AP	RX	No	No

Market Dynamics and Financial Trajectory for Bupivacaine Hydrochloride with Epinephrine

Last updated: August 2, 2025

Introduction

Bupivacaine hydrochloride combined with epinephrine constitutes a pivotal segment within the local anesthetic landscape. With extensive applications ranging from surgical anesthesia to postoperative analgesia, this combination's market dynamics are shaped by evolving regulatory landscapes, technological innovations, and competitive forces. Understanding these elements is critical for stakeholders aiming to navigate the financial trajectory of this pharmaceutical compounded formulation.

Pharmacological Profile and Clinical Significance

Bupivacaine hydrochloride is a long-acting amide local anesthetic highly valued for its potency and duration of action. When combined with epinephrine, a vasoconstrictor, the formulation prolongs anesthetic effects and reduces systemic absorption, thereby minimizing toxicity risks. This combination is widely employed in regional blocks, obstetric anesthesia, and pain management procedures [1].

The clinical efficacy, safety profile, and cost-effectiveness underpin the high demand for bupivacaine with epinephrine, especially within hospital settings and outpatient surgical centers. The global increase in surgical procedures, along with an aging population, bolsters its market size.

Market Drivers

Growing Surgical Procedures and Pain Management Demand

An aging demographic with increased chronic disease prevalence drives the expansion of surgical interventions, thereby escalating demand for local anesthetics. According to the World Bank, the global volume of outpatient surgeries has increased by approximately 8% annually over the past five years [2].

Technological Advancements and Formulation Innovations

Enhanced drug delivery systems, such as liposomal formulations and sustained-release technologies, promise longer-lasting anesthesia with fewer doses, appealing to healthcare providers and patients. These innovations hold potential to alter the market by improving clinical outcomes and operational efficiency.

Regulatory Approvals and Reimbursement Policies

Stringent regulations safeguard patient safety but can delay product launches. Conversely, favorable reimbursement policies for specific anesthetic protocols incentivize adoption. Changes in FDA guidelines, for example, influence market entry strategies and product lifecycle management.

Emerging Competitive Landscape

While brand dominance of lead formulations like Marcaine (bupivacaine) with epinephrine remains strong, generics and regional players focusing on cost-effective manufacturing are increasing market access. Patent expirations and bioequivalence approvals stimulate generic competition, pressuring prices.

Market Challenges

Safety Concerns and Toxicity Advocacy

Serious adverse events associated with bupivacaine, including cardiotoxicity, prompt cautious prescribing. Strong regulatory scrutiny and safety alerts (e.g., from FDA warnings issued in 2010 regarding systemic toxicity) influence clinical utilization and, consequentially, revenue streams [3].

Price Pressure and Cost Containment

Insurance reimbursements and hospital procurement policies prioritize cost-efficiency, constraining profit margins. The rise of generics intensifies price competition, affecting revenue especially for products nearing patent expiration.

Supply Chain Disruptions

Manufacturing complexities, such as sourcing high-purity intermediates, and geopolitical factors may disrupt supply chains, impacting production volumes and financial forecasts.

Financial Trajectory and Market Outlook

The global local anesthetic market, estimated at USD 2.8 billion in 2022, is projected to grow at a CAGR of 4% through 2030 [4]. Bupivacaine hydrochloride with epinephrine, representing a significant share within this segment, is expected to experience stable growth, driven by perennial demand and technological enhancements.

Revenue Streams and Profitability

Premium formulations and novel delivery systems offer higher margins, while generic formulations, though less profitable, secure substantial volume share. Key manufacturers like AbbVie and ICU Medical benefit from established manufacturing capabilities and distribution networks, solidifying their market positions.

Impact of Patent Expirations

The impending expiration of patents on some branded formulations by mid-2020s is likely to catalyze a surge in generic product offerings. This shift may compress prices initially but eventually leads to broader access and volume-driven revenue growth.

Emerging Market Expansion

Growth in emerging economies, driven by expanding healthcare infrastructure and increasing surgical procedures, presents new revenue frontiers. Local manufacturing and technology transfers are strategic for tapping these markets.

Regulatory and Market Entry Considerations

New formulations, such as liposomal bupivacaine, face regulatory hurdles but can command premium pricing. Approvals from agencies like the FDA and EMA are pivotal milestones influencing financial trajectories. Moreover, reimbursement policies and clinical guidelines heavily influence adoption rates.

Opportunity and Risk Assessment

Opportunities:

• Innovating with sustained-release formulations.
• Expanding into emerging markets.
• Developing combination products with improved safety profiles.

Risks:

• Safety controversies impacting clinical use.
• Price pressures due to generic competition.
• Regulatory delays or restrictions.

Conclusion

The market landscape for bupivacaine hydrochloride with epinephrine is characterized by steady growth, driven by increasing global surgical procedures, technological innovations, and expanding markets. However, competitive dynamics, safety concerns, and regulatory changes pose notable challenges. Stakeholders must adopt adaptive strategies emphasizing innovation, compliance, and market diversification to capitalize on the sector’s favorable financial trajectory.

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Key Takeaways

• The global demand for local anesthetics, particularly bupivacaine with epinephrine, continues to grow driven by demographic and procedural factors.
• Technological advancements, including sustained-release formulations, are poised to enhance market offerings and profitability.
• Patent expirations and generic competition exert downward pressure on prices but open opportunities for volume growth, especially in emerging markets.
• Safety concerns necessitate rigorous regulatory compliance, influencing market access and product lifecycle.
• Strategic diversification and innovation are essential for stakeholders to maximize revenue and mitigate risks associated with market saturation and regulatory shifts.

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FAQs

1. How does safety concern influence the market for bupivacaine hydrochloride with epinephrine?
Safety issues, such as cardiotoxicity reports, lead to increased regulatory scrutiny and cautious prescribing. These concerns can limit market growth but also drive innovation toward safer formulations.

2. What impact do patent expirations have on the market size?
Patent expirations typically initiate a surge in generic competition, which can lower prices but also expand overall market volume by making the drug more accessible to broader populations.

3. Are there emerging markets for bupivacaine with epinephrine?
Yes, regions like Asia-Pacific and Latin America are experiencing increased healthcare investments, leading to greater adoption of local anesthetics, including bupivacaine formulations.

4. What role do technological innovations play in the financial prospects?
Innovations such as liposomal or sustained-release variants can command higher prices, improve clinical outcomes, and differentiate products, positively influencing revenue streams.

5. How do regulatory frameworks influence market entry and growth?
Regulatory approvals, safety standards, and reimbursement policies determine the speed and cost of market entry. Favorable policies facilitate growth, while stringent regulations may delay product launches and impact profitability.

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Sources:
[1] Medical literature and clinical guidelines on local anesthetics.
[2] World Bank reports on global surgical trends.
[3] FDA safety alerts and regulatory communications.
[4] Market research reports from industry analysts like Grand View Research and MarketsandMarkets.