MEPIVACAINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for mepivacaine hydrochloride and what is the scope of patent protection?

Mepivacaine hydrochloride is the generic ingredient in seven branded drugs marketed by Solvay, Eastman Kodak, Hospira, Septodont, Belmora Llc, Hospira Inc, Intl Medication Sys, Watson Labs, Dentsply Pharm, Fresenius Kabi Usa, and Deproco, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for mepivacaine hydrochloride. Eleven suppliers are listed for this compound.

Summary for MEPIVACAINE HYDROCHLORIDE

US Patents:	0
Tradenames:	7
Applicants:	11
NDAs:	16
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	90
What excipients (inactive ingredients) are in MEPIVACAINE HYDROCHLORIDE?	MEPIVACAINE HYDROCHLORIDE excipients list
DailyMed Link:	MEPIVACAINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for MEPIVACAINE HYDROCHLORIDE

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

Sponsor	Phase
Nova Scotia Health Authority	PHASE4
Medical University of South Carolina	PHASE3
Sunnybrook Health Sciences Centre	PHASE4

See all MEPIVACAINE HYDROCHLORIDE clinical trials

Pharmacology for MEPIVACAINE HYDROCHLORIDE

Drug Class	Amide Local Anesthetic
Physiological Effect	Local Anesthesia

Medical Subject Heading (MeSH) Categories for MEPIVACAINE HYDROCHLORIDE

Anesthetics, Local

Anatomical Therapeutic Chemical (ATC) Classes for MEPIVACAINE HYDROCHLORIDE

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

US Patents and Regulatory Information for MEPIVACAINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Deproco	SCANDONEST PLAIN	mepivacaine hydrochloride	INJECTABLE;INJECTION	088387-001	Oct 10, 1984		RX	No	Yes
Fresenius Kabi Usa	POLOCAINE	mepivacaine hydrochloride	INJECTABLE;INJECTION	089407-001	Dec 1, 1986		RX	No	No
Hospira	CARBOCAINE	mepivacaine hydrochloride	INJECTABLE;INJECTION	012250-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Fresenius Kabi Usa	POLOCAINE-MPF	mepivacaine hydrochloride	INJECTABLE;INJECTION	089406-001	Dec 1, 1986		RX	No	No

Market Dynamics and Financial Trajectory for Mepivacaine Hydrochloride

Last updated: December 28, 2025

Executive Summary

Mepivacaine Hydrochloride, a widely utilized local anesthetic, has sustained relevance within the pharmaceutical industry owing to its efficacy in medical procedures including dental, regional anesthesia, and minor surgeries. Despite the proliferation of alternative anesthetics such as lidocaine, mepivacaine maintains a niche through its favorable pharmacokinetic profile. The global market for mepivacaine hydrochloride is anticipated to grow modestly at a CAGR of approximately 3% between 2023 and 2030, driven by increasing procedural volumes and legal/regulatory frameworks favoring local anesthesia modalities. This report critically analyzes the recent market trends, regulatory landscape, competitive environment, and projected financial trajectory underpinning mepivacaine hydrochloride.

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Summary of Key Market Insights

Aspect	Details
Market Size (2023)	Estimated USD 150 million globally
CAGR (2023–2030)	3% (approximate)
Major Markets	North America, Europe, Asia-Pacific
Key Drivers	Rising outpatient procedures, safety profile, technological advances
Challenges	Competition from lidocaine and articaine, regulatory hurdles, patent expirations
Leading Companies	Hospira (Pfizer), DePuy Synthes, Biocon, Hikma Pharmaceuticals

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What Are the Market Dynamics Shaping Mepivacaine Hydrochloride?

How Does Demand for Local Anesthetics Drive Market Growth?

The global demand for local anesthetics like mepivacaine is primarily propelled by an increase in outpatient and minimally invasive procedures. The World Health Organization (WHO) reports a 15% rise in outpatient surgeries from 2018-2022, reflecting demographic shifts, technological progress, and patient preferences for minimally invasive treatments. These procedures generally favor local anesthetics due to their safety and cost-effectiveness.

What Are the Trends in Regulatory and Reimbursement Policies?

Regulatory agencies—including the FDA (U.S.) and EMA (Europe)—have facilitated access to local anesthetics through streamlined approval pathways, especially for established drugs like mepivacaine. Reimbursement schemes favor minimally invasive approaches, further incentivizing the use of local anesthetics. However, evolving regulations concerning compounding practices and quality controls may pose future challenges.

How Does Competitive Pressure Influence Market Share?

Mepivacaine faces stiff competition from lidocaine, which benefits from broader awareness and patent protection until 2018 in select markets. Articaine is also increasingly popular due to its rapid onset and potency. Companies continuously innovate formulations—for example, combining mepivacaine with vasoconstrictors—to differentiate products and extend lifecycle.

What Is the Impact of Patent Expirations and Generic Entry?

Patents for certain formulations of mepivacaine have expired or are nearing expiration, prompting the entry of generics. This significantly impacts pricing, margins, and overall market revenues. The increased availability of generics has led to a price erosion estimated at 10-15% annually in key markets.

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Financial Trajectory: Revenue, Cost, and Profitability Analysis

Historical and Projected Revenue Trends

Year	Estimated Global Revenue (USD millions)	Notes
2020	140	Stable, moderate growth
2021	145	Slight increase due to procedural volume growth
2022	148	Marginal gains, market saturation
2023	150	Estimated, initial stabilization
2024–2030	CAGR ~3%	Steady incremental growth driven by procedural volume expansion

Pricing Dynamics and Margins

Element	Sub-parameters	Impact
Price Erosion	10-15% annually (generic competition)	Reduces revenue per unit sold
Cost of Goods Sold (COGS)	Stabilized with generic manufacturing	Slight decrease expected
R&D Spending	Primarily for formulation improvements	Marginal impact, as innovation is limited

Profitability Outlook

Operating margins are projected to stabilize between 15-20% due to competitive pressures. Companies adopting cost-effective manufacturing and optimizing supply chains could maintain better margins. The entry of biosimilar or alternative anesthetic products may further compress profitability.

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Market Segmentation and Geographic Insights

Segment by Formulation

Formulation Type	Market Share (2023)	Characteristics
Injectable	80%	Widespread, used in dental and surgical procedures
Topical	15%	Limited; adjunct use
Other (e.g., patches)	5%	Emerging segment

Regional Market Share

Region	Market Share (2023)	Growth Drivers
North America	45%	High procedure volume, advanced healthcare infrastructure
Europe	25%	Aging population, procedural complexity
Asia-Pacific	20%	Growing healthcare access, developing infrastructure
Rest of World	10%	Emerging markets

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Comparison with Competing Local Anesthetics

Parameter	Mepivacaine	Lidocaine	Articaine
Onset of Action	5-10 mins	2-4 mins	1-3 mins
Duration of Anesthesia	90-180 mins	60-120 mins	90-180 mins
Toxicity Profile	Favorable	Well-known	Similar, with some concerns over nerve injury
Market Penetration	Moderate	Dominant	Growing

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Regulatory and Policy Landscape: Impacts on Market Dynamics

Policy/Regulation	Impact	Date/Authority	Notes
FDA Approval (Existing Drugs)	Maintains market access	1970s onward	Generics also approved
EMA Quality Standards	Ensures safety, limits market entry	2010s	Stricter manufacturing standards
Patent Laws	Affects exclusivity	Varies	Patent expirations influence generics
Reimbursement Policies	Impact procedure volumes	Ongoing	Favor lower-cost local anesthetics

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Future Outlook: Opportunities and Challenges

Opportunities

• Growing outpatient and minimally invasive procedures worldwide.
• Innovation in formulations, such as sustained-release systems.
• Expansion into emerging markets with improving healthcare access.
• Collaboration with key hospitals and dental clinics.

Challenges

• Patent expirations increasing generic competition.
• Competition from newer local anesthetic agents with superior pharmacokinetics.
• Stringent regulatory standards on manufacturing and quality.
• Price pressures affecting margins.

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Key Takeaways

• The global market for mepivacaine hydrochloride remains steady, driven predominantly by procedural growth in outpatient and dental care.
• Market share is impacted substantially by generic competition and alternative agents like lidocaine and articaine.
• Revenue growth prospects are modest, with a predicted CAGR of approximately 3% through 2030.
• Regulatory landscapes favor established drugs but pose challenges through increasing quality standards.
• Innovation and strategic positioning in emerging markets will be crucial for sustaining profitability.

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FAQs

1. What are the primary factors influencing the market demand for mepivacaine hydrochloride?

The main drivers include increased outpatient surgeries, preference for local anesthetics due to safety profiles, and technological advances leading to new formulations.

2. How does generic competition affect mepivacaine's market revenue?

Patents expiry and the entry of generics have led to a 10-15% annual decrease in prices, significantly impacting revenue margins.

3. What regions are expected to offer the highest growth potential for mepivacaine?

Asia-Pacific and Latin America exhibit high growth potential owing to expanding healthcare infrastructure and rising procedural volumes.

4. Are there any notable innovations on the horizon for mepivacaine?

Formulation innovations such as sustained-release injections, combined formulations, and improved delivery systems are under development.

5. How might regulatory changes influence the future market for mepivacaine?

Stricter manufacturing and quality standards may increase costs but could also bolster market confidence. Regulatory pathways for biosimilars or alternatives could challenge traditional formulations.

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References

[1] WHO Global Health Observatory Data, 2022

[2] U.S. FDA Drug Approvals Database, 2023

[3] European Medicines Agency (EMA), 2022 Annual Report

[4] Market Research Future (MRFR), “Local Anesthetics Market,” 2023

[5] GlobalData Reports, “Pharmaceutical Industry Trends,” 2022