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. Twelve 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:	12
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	81
Patent Applications:	1,684
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
Indiana University	Phase 4
NorthShore University HealthSystem	Phase 4
Johnny K. Lee	Phase 4

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
Fresenius Kabi Usa	POLOCAINE-MPF	mepivacaine hydrochloride	INJECTABLE;INJECTION	089406-001	Dec 1, 1986	AP	RX	No	No
Fresenius Kabi Usa	POLOCAINE	mepivacaine hydrochloride	INJECTABLE;INJECTION	089410-001	Dec 1, 1986	AP	RX	No	No
Hospira	CARBOCAINE	mepivacaine hydrochloride	INJECTABLE;INJECTION	012250-005	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Fresenius Kabi Usa	POLOCAINE	mepivacaine hydrochloride	INJECTABLE;INJECTION	089407-001	Dec 1, 1986	AP	RX	No	No
Deproco	SCANDONEST PLAIN	mepivacaine hydrochloride	INJECTABLE;INJECTION	088387-001	Oct 10, 1984		RX	No	Yes
Hospira	CARBOCAINE	mepivacaine hydrochloride	INJECTABLE;INJECTION	012250-002	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Solvay	ARESTOCAINE HYDROCHLORIDE	mepivacaine hydrochloride	INJECTABLE;INJECTION	084777-002	Apr 18, 1982		DISCN	No	No

MEPIVACAINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mepivacaine Hydrochloride

Market Overview

Mepivacaine hydrochloride is a local anesthetic that has been a staple in medical and dental procedures since its introduction in the 1960s. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global local anesthesia drugs market, which includes mepivacaine hydrochloride, was valued at USD 4.01 billion in 2023 and is projected to grow at a CAGR of 3.6% from 2024 to 2030[1].

Segmentation and Revenue

Drug Outlook

Mepivacaine hydrochloride is part of the broader local anesthetic market, which is segmented by drug type. While lidocaine dominates the market with a 28.7% share in 2023, mepivacaine remains a significant player, particularly in dental and medical procedures[1].

Application Outlook

Mepivacaine is primarily used in injectable and surface anesthetic forms. Injectables accounted for the largest market revenue share of 59.5% in 2023, driven by their increasing use in surgical procedures[1].

End-User Demand

Dental Procedures

Mepivacaine is widely used in dental procedures, including infiltration and nerve blocks in adults and pediatric patients. Its use in dentistry has remained strong due to its safety profile and effectiveness, especially in medically compromised patients[2][4].

Medical Procedures

In medical settings, mepivacaine is used for various procedures where local anesthesia is required. Its formulation with or without vasoconstrictors makes it versatile for different patient needs[4].

Regional Market

North America and Europe

In North America and Europe, mepivacaine continues to be a valuable local anesthetic, though its market share has been somewhat eclipsed by newer agents like articaine. However, it remains the third most used agent in many regions due to its safety and efficacy[4].

Middle East and Africa (MEA)

The MEA region is anticipated to witness significant growth in the local anesthesia drugs market, including mepivacaine, due to growing public awareness and demographic shifts such as urbanization and lifestyle changes[1].

Competitive Landscape

The local anesthesia drugs market is competitive, with key players including Johnson & Johnson Services Inc, Pfizer Inc., AstraZeneca plc, and Novartis AG. These companies are expanding their market share through new product launches, collaborations, and other strategic initiatives[1].

Financial Trajectory

Revenue Trends

The revenue from mepivacaine hydrochloride is expected to grow in line with the overall local anesthesia drugs market. The increasing demand for surgical and dental procedures, coupled with the aging population and rising chronic diseases, will drive this growth[1].

Challenges and Opportunities

Despite its established presence, mepivacaine hydrochloride faces challenges such as shortages, which can impact its financial trajectory. For instance, recent shortages of mepivacaine hydrochloride injection have posed financial risks for manufacturers and health systems[5].

However, advancements in delivery systems, such as computer-based local anesthetic delivery and vibrotactile devices, are expected to boost the demand for local anesthetics like mepivacaine[1].

Pharmacological and Clinical Aspects

Metabolism and Excretion

Mepivacaine undergoes extensive hepatic biotransformation, with less than 5% of the unchanged drug excreted in the urine. Its metabolism involves hydroxylation and N-demethylation, which are key detoxification reactions[2][4].

Safety Profile

Mepivacaine has a favorable safety profile, particularly in patients with cardiovascular disease or elderly patients, where it is often preferred over lidocaine due to its lower risk of elevating blood pressure or heart rate[4].

Side Effects and Precautions

While generally safe, mepivacaine can cause side effects such as methemoglobinemia, especially in patients with certain deficiencies or conditions. Close monitoring and immediate treatment are necessary to manage such adverse effects[2].

Key Takeaways

• Market Growth: The local anesthesia drugs market, including mepivacaine hydrochloride, is expected to grow at a CAGR of 3.6% from 2024 to 2030.
• Segmentation: Mepivacaine is primarily used in injectable and surface anesthetic forms, with a strong presence in dental procedures.
• Regional Demand: The MEA region is expected to see significant growth due to increasing public awareness and demographic changes.
• Competitive Landscape: Key players are expanding their market share through new product launches and strategic collaborations.
• Financial Trajectory: Revenue is expected to grow, but challenges like shortages need to be addressed.

FAQs

Q: What is the primary use of mepivacaine hydrochloride?

A: Mepivacaine hydrochloride is primarily used for producing local anesthesia in dental and medical procedures.

Q: How does mepivacaine hydrochloride compare to other local anesthetics in terms of safety?

A: Mepivacaine hydrochloride is considered safer for patients with cardiovascular disease or elderly patients due to its lower risk of elevating blood pressure or heart rate compared to lidocaine.

Q: What are the potential side effects of mepivacaine hydrochloride?

A: Potential side effects include methemoglobinemia, persistent paresthesias, and central nervous system reactions such as dizziness and convulsions.

Q: How is mepivacaine hydrochloride metabolized and excreted?

A: Mepivacaine undergoes extensive hepatic biotransformation, with less than 5% of the unchanged drug excreted in the urine.

Q: What are the regional growth prospects for mepivacaine hydrochloride?

A: The Middle East and Africa (MEA) region is expected to witness significant growth due to growing public awareness and demographic shifts.

Sources

1. Grand View Research: Local Anesthesia Drugs Market Size & Share Report, 2030.
2. DailyMed: Mepivacaine HCl 3% (30 mg/mL).
3. Market Research Future: Dental Carpule Market Size, Share and Trends | Industry Forecast to 2032.
4. AGD: Mepivacaine: a closer look at its properties and current utility.
5. RxStrategies: Clinical Insights: January 26, 2022.