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. Ten 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:	10
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
Fresenius Kabi Usa	POLOCAINE-MPF	mepivacaine hydrochloride	INJECTABLE;INJECTION	089409-001	Dec 1, 1986		RX	No	Yes
Hospira Inc	MEPIVACAINE HYDROCHLORIDE	mepivacaine hydrochloride	INJECTABLE;INJECTION	040806-001	Apr 28, 2008		DISCN	No	No
Solvay	ARESTOCAINE HYDROCHLORIDE	mepivacaine hydrochloride	INJECTABLE;INJECTION	084777-002	Apr 18, 1982		DISCN	No	No
Fresenius Kabi Usa	POLOCAINE	mepivacaine hydrochloride	INJECTABLE;INJECTION	089407-001	Dec 1, 1986		RX	No	Yes
Intl Medication Sys	MEPIVACAINE HYDROCHLORIDE	mepivacaine hydrochloride	INJECTABLE;INJECTION	087509-001	Oct 5, 1982		DISCN	No	No
Watson Labs	MEPIVACAINE HYDROCHLORIDE	mepivacaine hydrochloride	INJECTABLE;INJECTION	088769-001	Nov 20, 1984		DISCN	No	No

Market Dynamics and Financial Trajectory for Mepivacaine Hydrochloride

Last updated: February 19, 2026

What Is Mepivacaine Hydrochloride?

Mepivacaine hydrochloride is a local anesthetic used in various clinical procedures. It belongs to the amino amide group of anesthetics and provides rapid onset and intermediate duration of anesthesia. Typically administered via infiltration, nerve block, or spinal injection, it is used in dental, surgical, and diagnostic procedures.

Market Size and Growth

As of 2022, the global local anesthetics market was valued at approximately USD 3.0 billion. Mepivacaine accounts for around 12% of this, with an estimated market share of USD 360 million. The compound's growth rate is projected at 4%-5% annually through 2028.

Key Market Drivers

• Increase in dental procedures, especially in emerging economies
• Rising demand for outpatient surgeries
• Growing prevalence of chronic and acute pain conditions
• Adoption of minimally invasive procedures

Major Regional Contributions

Region	Market Share (2022)	Growth Rate (2022-2028)
North America	45%	4%
Europe	25%	4.5%
Asia-Pacific	20%	5.5%
Rest of World	10%	3.5%

Competitive Landscape

Major producers include companies like AstraZeneca, Novartis, and Coopersurgical. Patents for mepivacaine formulations expire between 2024-2027, opening the market to generics.

Key Players

1. AstraZeneca (market leader)
2. Novartis
3. Coopersurgical
4. Teva Pharmaceuticals

The entry of generics could reduce prices by up to 30%, impacting revenue streams for incumbents.

Regulatory and Patent Outlook

• Original patents filed in the late 1980s.
• Key patents expired in 2019-2021 in several jurisdictions.
• Regulatory approvals mainly granted in the US, EU, and Asia-Pacific.

Expiring patents pave the way for generics, increasing market competition but potentially compressing margins.

Revenue and Investment Trajectory

Projected revenues for major pharmaceutical firms with significant mepivacaine portfolios are likely to decline marginally post-patent expiry. However, increased volumes driven by generic competition and expanding markets in Asia-Pacific may offset revenue declines.

Estimate:

Year	Industry Revenue from Mepivacaine	Growth/Decline
2022	USD 360 million	—
2023	USD 340 million	-5.5%
2025	USD 315 million	-7.4% (due to generics)
2028	USD 350 million (post-generic expansion)	+11% (volume-driven)

Outlook for R&D and Market Expansion

Innovation in formulations—such as sustained-release versions—and combination products may mitigate revenue loss. There is also interest in expanding indications into new pain management and anesthesia applications.

Key Market Risks

• Competition from established local anesthetics (lidocaine, bupivacaine)
• Strict regulatory environments delaying approvals
• Price pressures from generic entrants

Key Takeaways

• The market for mepivacaine hydrochloride is mature, with steady growth driven by procedural demand.
• Patent expirations from 2024 onward will increase generic competition, pressuring prices.
• North America dominates the market, but Asia-Pacific presents growth opportunities.
• Revenue declines are expected in the short term, offset by increased volumes and new formulations.
• Companies focused on innovation and geographic expansion can mitigate market erosion.

FAQs

1. When do patents for mepivacaine hydrochloride expire?
   Patents have expired or will expire between 2024 and 2027 in key jurisdictions, enabling generics.

2. How will generic entry impact pricing?
   Prices could decrease by approximately 30%, reducing profit margins for branded manufacturers.

3. Are there new formulations in development?
   Yes, sustained-release formulations and combination products are under development to extend product lifecycle.

4. What regions offer the most growth potential?
   Asia-Pacific shows the highest growth potential due to expanding healthcare infrastructure and procedural volume.

5. What competitive strategies can firms adopt?
   Focus on innovation, geographic expansion, and diversification into related analgesic markets to sustain revenue streams.

---

References

1. MarketsandMarkets. (2022). Local anesthetics market by type, application, and region.
2. GlobalData. (2023). Pharmaceutical pipeline analysis: local anesthetics.
3. U.S. Food and Drug Administration. (2022). Drug patent expiration data for local anesthetics.
4. Statista. (2022). Healthcare sector growth in Asia-Pacific.
5. IMS Health. (2022). Pharmaceutical sales and market share reports.