Mepivacaine hydrochloride - Generic Drug Details

What are the generic 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:	89
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
Medical University of South Carolina	PHASE3
Sunnybrook Health Sciences Centre	PHASE4
Aristotle University Of Thessaloniki	NA

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
Septodont	ISOCAINE HYDROCHLORIDE	mepivacaine hydrochloride	INJECTABLE;INJECTION	080925-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Eastman Kodak	CARBOCAINE	mepivacaine hydrochloride	INJECTABLE;INJECTION	012125-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Intl Medication Sys	MEPIVACAINE HYDROCHLORIDE	mepivacaine hydrochloride	INJECTABLE;INJECTION	087509-001	Oct 5, 1982		DISCN	No	No
Hospira	CARBOCAINE	mepivacaine hydrochloride	INJECTABLE;INJECTION	012250-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Market Dynamics and Financial Trajectory for Mepivacaine Hydrochloride

Last updated: July 27, 2025

---

Introduction

Mepivacaine hydrochloride is a widely used amide-type local anesthetic predominantly employed in dental, surgical, and diagnostic procedures. Known for its rapid onset and intermediate duration of action, this compound has established itself as a critical agent within the anesthetic landscape. Analyzing the current market dynamics and forecasting the financial trajectory of mepivacaine hydrochloride requires a comprehensive understanding of its manufacturing, demand drivers, regulatory environment, competitive landscape, and emerging trends.

---

Market Overview

Global Market Size and Demand

The global local anesthetics market, valued at approximately USD 4.7 billion in 2022, is projected to reach USD 6.3 billion by 2030, growing at a CAGR of around 4.2% (2023–2030) [1]. Mepivacaine hydrochloride contributes a significant segment within this broader market, especially favored in dental practices and outpatient surgical interventions due to its favorable pharmacokinetics.

Key Geographic Markets

North America dominates the market, driven by high dental procedure volumes, advanced healthcare infrastructure, and favorable reimbursement policies. Europe follows closely, with increasing adoption in outpatient surgeries. Asia-Pacific presents substantial growth potential owing to expanding healthcare access, rising dental care awareness, and developing pharmaceutical manufacturing capabilities.

---

Market Drivers

Growing Dental and Surgical Procedures

The increasing prevalence of dental caries, periodontal diseases, and cosmetic dentistry procedures fuels demand for local anesthetics like mepivacaine hydrochloride. A report by the American Dental Association suggests that over 200 million dental visits annually in the U.S. alone rely on local anesthetics [2].

Preference for Amide-Type Anesthetics

Mepivacaine's relatively lower vasodilatory activity, compared to other local anesthetics, allows for better control of anesthesia duration and reduced need for vasoconstrictors, making it an attractive option for both practitioners and patients.

Advancements in Drug Delivery

Innovations such as sustained-release formulations and improved injection techniques enhance patient comfort and procedure efficacy, indirectly boosting mepivacaine utilization.

---

Market Challenges

Regulatory and Patent Landscape

Although mepivacaine is a long-established drug, patent expirations for various formulations have opened the market for generic versions, intensifying price competition. Regulatory hurdles across countries can delay new formulations, impacting revenue streams.

Side Effect Profile and Alternatives

Potential adverse effects, such as systemic toxicity and allergic reactions, necessitate careful administration. The advent of alternative anesthetic agents or adjuncts, like buffered formulations or newer local anesthetics with improved profiles (e.g., articaine), pose competitive threats.

Supply Chain Constraints

The manufacturing process involves complex synthesis routes, and recent disruptions—supply chain bottlenecks, raw material shortages—can influence pricing and availability.

---

Competitive Landscape

The market for mepivacaine hydrochloride is characterized by a combination of global pharmaceutical giants and niche generics manufacturers. Key players include:

• Novartis (via its generic branch)
• Alkaloida Chemical Company
• Teva Pharmaceuticals
• Mundipharma
• Zhejiang Hisun Pharmaceutical Co.

Their strategies encompass expanding manufacturing capacity, acquiring regional rights, and investing in formulations with extended duration or reduced toxicity to differentiate products.

---

Regulatory Environment and Patent Trends

The expiration of key patents over the past decade has led to a surge in generic formulations, reducing prices and expanding access but pressuring branded products' profitability [3].

Regulatory bodies (FDA, EMA, PMDA) continue to emphasize safety and efficacy standards, influencing formulations and manufacturing practices. Adaptive approval pathways for novel formulations or delivery systems could present new revenue streams.

---

Financial Trajectory Forecast

The revenue for mepivacaine hydrochloride will largely hinge on generic market penetration, new formulations, and regional demand. The following projections consider various factors:

• Short-term (2023-2025): Continued growth driven by expanding dental procedures and existing product pipelines. Price erosion due to generic competition will moderate margins.
• Mid-term (2026-2028): Potential stagnation as biosimilar-like competition stabilizes market shares. Commercializing innovative formulations could offset margin pressures.
• Long-term (2029+): Market saturation may lead to plateauing revenues unless new therapeutic indications or novel delivery methods emerge.

An optimistic scenario suggests a CAGR of approximately 3-4%, considering the consolidation in manufacturing and market expansion in emerging economies. Conversely, intensified competition and regulatory barriers could dampen growth prospects.

---

Emerging Trends Impacting Future Market Dynamics

Development of Novel Delivery Systems

Liposomal formulations, biocompatible polymers, or combined anesthetic preparations promise more efficacious and sustained effects, potentially commanding higher prices and expanding clinical applications.

Integration of Digital Technologies

Enhanced injection techniques through robotics or augmented reality could improve precision and patient outcomes, indirectly bolstering demand for high-quality anesthetics like mepivacaine.

Focus on Safety and Tolerability

Advances in pharmacogenomics to personalize anesthesia and mitigate adverse effects could transform product development strategies, emphasizing safer formulations.

---

Conclusion

Mepivacaine hydrochloride stands at an intersection of mature technology and evolving clinical needs. Its market remains robust, driven primarily by dental and outpatient surgical procedures. The financial trajectory indicates stable growth tempered by intensified generic competition, regulatory considerations, and the advent of innovative formulations. Stakeholders must prioritize R&D investments, diversify formulations, and navigate regulatory landscapes adeptly to capitalize on emerging opportunities.

---

Key Takeaways

• The global local anesthetics market is projected to grow steadily, with mepivacaine hydrochloride maintaining a significant share due to its favorable pharmacological profile.
• Market growth is driven by increasing dental procedures, outpatient surgeries, and innovations in delivery systems.
• Patent expirations and competitive generic manufacturing have decreased prices but foster increased accessibility.
• Innovations such as sustained-release formulations, improved safety profiles, and digitized delivery could broaden the market.
• Strategic investment in regional markets, formulation development, and navigating regulatory pathways are critical to optimizing financial outcomes.

---

FAQs

1. What factors influence the pricing of mepivacaine hydrochloride in global markets?
Pricing is affected by patent status, manufacturing costs, regulatory approval processes, regional competition, and the prevalence of generic formulations.

2. How is the supply chain impacted by recent global disruptions?
Supply chain disruptions have led to raw material shortages and manufacturing delays, influencing availability and pricing, especially in regions dependent on imported intermediates.

3. Are there emerging alternatives to mepivacaine hydrochloride?
Yes, agents like articaine, lidocaine, and bupivacaine are competitors. Additionally, innovative delivery systems and formulations are in development to enhance safety and duration.

4. What regulatory trends are shaping the future of mepivacaine hydrochloride?
Regulatory agencies emphasize safety, efficacy, and quality standards. Expedited approval pathways for reformulations and combination products could influence market dynamics.

5. What growth opportunities exist in emerging markets?
Rapid healthcare infrastructure development, rising dental care awareness, and increasing outpatient procedures present significant growth prospects, especially with localized manufacturing and regulatory compliance.

---

References

[1] MarketWatch. (2023). "Global Local Anesthetics Market Size & Share."
[2] American Dental Association. (2022). "Dental Procedure Statistics."
[3] IQVIA. (2021). "Pharmaceutical Patent Expirations and Market Impact."