LIDOCAINE - Generic Drug Details

What are the generic drug sources for lidocaine and what is the scope of freedom to operate?

Lidocaine is the generic ingredient in forty-six branded drugs marketed by Astrazeneca, Noven, Carlisle, Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Belmora Llc, Chartwell Rx, Cosette, Encube, Fougera Pharms Inc, Geneyork Pharms, Glenmark Pharms Ltd, Macleods Pharms Ltd, Quagen, Rising, Septodont Inc, Strides Pharma, Sun Pharma Canada, Teva Pharms Usa, Vitruvias Therap, Actavis Labs Ut Inc, Amneal, Difgen Pharms, Ibsa, Nal Pharm, Noven Pharms Inc, Pharmobedient, Teikoku Pharma Usa, Scilex Pharms, Medrx Usa, Thea Pharma, Abbott, Abraxis Pharm, Afaxys, Am Regent, Aspiro, B Braun Medical, Bel Mar, Dell Labs, Elkins Sinn, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Huons, Intl Medication, Luitpold, Lyphomed, Mankind Pharma, Miles, Neocubes Pharma, Spectra Mdcl Devices, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Yiling, Baxter Hlthcare, B Braun, Extrovis, Hikma, Pharmaton, Meridian Medcl Techn, Dentsply Pharm, Bionpharma, Sagent Pharms Inc, Sentiss, Watson Labs Inc, Rubicon Research, Actavis Mid Atlantic, Chartwell Molecular, Pai Holdings Pharm, Kendall Il, Lannett Co Inc, Novitium Pharma, Paco, The J Molner, Powder Pharms, Pfizer, Teva Branded Pharm, Fougera Pharms, Padagis Us, Zydus Lifesciences, Crescita Therap, and Galen Specialty, and is included in one hundred and sixty-six NDAs. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lidocaine has thirty-nine patent family members in nineteen countries.

There are twenty-nine drug master file entries for lidocaine. Forty-four suppliers are listed for this compound.

Summary for LIDOCAINE

International Patents:	39
US Patents:	15
Tradenames:	46
Applicants:	87
NDAs:	166
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	2,102
Patent Applications:	7,521
Drug Prices:	Drug price trends for LIDOCAINE
Drug Sales Revenues:	Drug sales revenues for LIDOCAINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LIDOCAINE
What excipients (inactive ingredients) are in LIDOCAINE?	LIDOCAINE excipients list
DailyMed Link:	LIDOCAINE at DailyMed

See drug prices for LIDOCAINE

See drug sales revenues for LIDOCAINE

Recent Clinical Trials for LIDOCAINE

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

Sponsor	Phase
Vanderbilt University Medical Center	PHASE4
Assiut University	NA
Universidad Industrial de Santander	PHASE1

See all LIDOCAINE clinical trials

Pharmacology for LIDOCAINE

Drug Class	Amide Local Anesthetic Antiarrhythmic
Physiological Effect	Local Anesthesia

Medical Subject Heading (MeSH) Categories for LIDOCAINE

Anesthetics, Local

Anti-Arrhythmia Agents

Voltage-Gated Sodium Channel Blockers

Anatomical Therapeutic Chemical (ATC) Classes for LIDOCAINE

C01BB	Antiarrhythmics, class Ib
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

C05AD	Local anesthetics
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D04AB	Anesthetics for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

R02AD	Anesthetics, local
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

S01HA	Local anesthetics
S01H	LOCAL ANESTHETICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02DA	Analgesics and anesthetics
S02D	OTHER OTOLOGICALS
S02	OTOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for LIDOCAINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZTLIDO	Topical Patch	lidocaine	1.80%	207962	1	2022-03-17
LIDODERM	Topical Patch	lidocaine	5%	020612	1	2009-11-13

US Patents and Regulatory Information for LIDOCAINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Regent	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	091564-001	Aug 14, 2015		DISCN	No	No
Abraxis Pharm	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	017508-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Extrovis	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	lidocaine hydrochloride	INJECTABLE;INJECTION	090665-001	Sep 27, 2010		DISCN	No	No
Watson Labs	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	083627-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for LIDOCAINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999
Noven	DENTIPATCH	lidocaine	PATCH;TOPICAL	020575-002	May 21, 1996
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999
Noven	DENTIPATCH	lidocaine	FILM, EXTENDED RELEASE;BUCCAL	020575-001	May 21, 1996

International Patents for LIDOCAINE

Country	Patent Number	Title	Estimated Expiration
Taiwan	201318652	Non-aqueous patch
Spain	2845524
Hungary	E039266
Serbia	57451

Market Dynamics and Financial Trajectory for Lidocaine: An In-Depth Analysis

Last updated: September 13, 2025

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Introduction

Lidocaine, a widely used local anesthetic and antiarrhythmic agent, plays a pivotal role in anesthesia, pain management, and cardiac care. Its extensive application across healthcare settings makes it a cornerstone drug within the pharmaceutical landscape. This report provides a comprehensive analysis of the current market dynamics and financial trajectory of lidocaine, elucidating factors that influence its demand, value chain, regulatory environment, and future growth prospects.

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Market Overview

Lidocaine's global market is characterized by high prevalence in both developed and emerging markets, driven by an aging population, rising procedural interventions, and expanding indications. Market valuations estimate the global lidocaine market at approximately USD 950 million in 2022, with projections to grow at a CAGR of roughly 4.5% from 2023 to 2030 [1].

Key segments include:

• Pharmaceutical formulations: Injectable solutions, topical gels, patches, and creams.
• Therapeutic applications: Local anesthesia, antiarrhythmic therapy, neurology, and dental procedures.
• Geographic distribution: North America dominates due to high healthcare expenditure, with significant growth potential in Asia-Pacific driven by expanding healthcare infrastructure.

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Market Drivers

Growing procedural volume in healthcare

Advancements in diagnostic and surgical procedures—such as minimally invasive surgeries, dental interventions, and pain management—necessitate effective anesthetics. Lidocaine remains a first-line choice due to its rapid onset and safety profile [2].

Aging population and chronic pain prevalence

The global geriatric population is increasing, heightening demand for pain management solutions. Lidocaine's topical and injectable formulations are essential in managing chronic pain and neuropathic conditions, bolstering market expansion.

Regulatory approvals and product innovations

Continued regulatory approvals for new formulations (e.g., extended-release patches) and off-label uses stimulate market growth. Pharmaceutical companies also invest in novel delivery systems (e.g., nanocarriers), enhancing efficacy and patient compliance.

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Market Restraints

Regulatory and safety concerns

While lidocaine has a well-established safety profile, adverse effects like CNS toxicity and cardiac arrhythmias from overdose restrict usage boundaries. Strict regulatory standards, particularly in the U.S. and Europe, pose hurdles for new formulations.

Market competition

Generic formulations substantially reduce costs, impacting the revenue of branded products. The presence of multiple generic manufacturers drives price competition but constrains profit margins for innovators.

Alternative therapies

Emergence of alternative local anesthetics and innovative pain management modalities (e.g., nerve blocks with other agents) threaten market share.

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Regulatory and Patent Landscape

Lidocaine's initial patents expired decades ago, leading to widespread generic availability. However, innovation in delivery systems, such as sustained-release patches (e.g., Lidoderm), remains protected under recent patents, offering high-margin opportunities until patent expiry [3]. Regulatory bodies like FDA and EMA impose stringent standards requiring continuous post-market surveillance and safety evaluations, influencing market entry and product evolution.

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Financial Trajectory and Revenue Trends

Historically, lidocaine has demonstrated stable revenue streams, driven predominantly by injectable and topical formulations. The market's financial trajectory is influenced by:

• Patent expiries: Generics have overtaken branded products, intensifying price competition but maintaining volume sales.
• Premium products: Innovative formulations with extended-release properties command higher prices, contributing to revenue differentiation.

Forecasts suggest that while overall revenues plateau in mature markets due to patent expirations and generic competition, emerging markets and new formulation approvals will sustain growth. The global lidocaine market is projected to achieve a revenue CAGR of approximately 4.5% from 2023-2030 [1].

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Emerging Trends and Future Opportunities

Novel delivery systems

Research into liposomal, nanoparticle-based, and transdermal patches aims to improve bioavailability, prolong action, and reduce adverse effects. These innovations offer premium pricing potential and market differentiation.

Expanding therapeutic indications

Investigations into lidocaine's role in neuropathic pain, depression (via intravenous infusion), and systemic applications could unlock new revenue streams and diversify usage.

Regulatory evolution

Streamlined approval pathways for reformulations and combination products will facilitate faster market entry, impacting the financial outlook positively.

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Market Challenges

• Pricing pressures from generics
• Stringent regulatory compliance costs
• Safety concerns limiting dosing and scope
• Competitive landscape with alternative agents

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Conclusion

Lidocaine's market maintains stability bolstered by its proven efficacy, safety, and versatility. Financial prospects are favorable, especially where innovation in delivery modalities and new therapeutic applications are pursued. Companies focusing on differentiated formulations, aligned with regulatory trends and safety standards, are well-positioned for sustained growth. Nonetheless, competitive pressures and regulatory constraints require strategic navigation to optimize financial returns.

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Key Takeaways

• The global lidocaine market is mature but exhibits growth opportunities through innovations in delivery systems and expanding therapeutic indications.
• Revenue stability is driven by high-volume applications in anesthesia, pain management, and cardiac care, balanced against generic price competition.
• Emerging markets and off-label uses may contribute to future market expansion.
• Development of premium formulations with extended-release properties can enhance profit margins.
• Regulatory compliance and safety considerations remain critical in sustaining market access and profitability.

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FAQs

1. What factors are expected to influence lidocaine’s growth in the coming years?
Growth will be driven by technological innovations in drug delivery, expanding therapeutic indications, and rising procedural volumes globally. Nonetheless, patent expiries and generic competition are significant factors tempering revenue expansion.

2. How does patent status impact lidocaine’s market revenue?
Patent expiries have led to widespread generic manufacturing, reducing prices and profit margins for branded formulations. Proprietary delivery systems and formulations are critical for maintaining higher margins.

3. What regulatory challenges does lidocaine face?
Regulations focus on safety, efficacy, and manufacturing standards. Any adverse safety concerns or deviations can lead to market restrictions or delays in approval of new formulations.

4. Which regions offer the highest potential for lidocaine market growth?
North America dominates due to healthcare infrastructure, but Asia-Pacific presents significant growth prospects driven by expanding healthcare access and procedural volumes.

5. What are the key innovation areas for future lidocaine products?
Innovations include sustained-release patches, liposomal encapsulations, nanocarrier formulations, and combination therapies to enhance efficacy and patient compliance.

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References

[1] Market Research Future. "Global Lidocaine Market." 2022.
[2] Smith, J., et al. "Trend in Local Anesthetics Usage." Journal of Anesthesia. 2021.
[3] PharmaPatent. "Recent Patent Trends in Lidocaine Formulations." 2022.