LIDOCAINE - Generic Drug Details

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

Lidocaine is the generic ingredient in forty-five branded drugs marketed by Astrazeneca, Noven, Carlisle, Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Belmora Llc, Cosette, Dr Reddys, Encube, Fougera Pharms Inc, Geneyork Pharms, Glenmark Pharms Ltd, Macleods Pharms Ltd, Quagen, Rising, Septodont Inc, Strides Pharma, Taro, Teva Pharms Usa, Vitruvias Therap, Actavis Labs Ut Inc, Amneal, Ibsa, Mylan Technologies, Nal Pharm, Noven Pharms Inc, Teikoku Pharma Usa, Scilex Pharms, Thea Pharma, Abbott, Abraxis Pharm, Afaxys, Am Regent, Aspiro, B Braun Medical Inc, 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, Sintetica Us, Spectra Mdcl Devices, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Baxter Hlthcare, B Braun, Hikma, Pharmaton, Meridian Medcl Techn, Dentsply Pharm, Bionpharma, Sagent Pharms Inc, Sentiss, Watson Labs Inc, Rubicon, Wockhardt Bio Ag, 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, Rhodes Pharms, Crescita Therap, and Galen Specialty, and is included in one hundred and sixty 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-seven patent family members in eighteen countries.

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

Summary for LIDOCAINE

International Patents:	37
US Patents:	15
Tradenames:	45
Applicants:	84
NDAs:	160
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	1,820
Patent Applications:	4,894
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
Sichuan Cancer Hospital and Research Institute	N/A
Jessyka Lighthall	Phase 3
Sawanpracharak hospital	N/A

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
Hospira	PEDIATRIC LTA KIT	lidocaine hydrochloride	SOLUTION;TOPICAL	085995-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Baxter Hlthcare	LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER	lidocaine hydrochloride	INJECTABLE;INJECTION	018461-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Fresenius Kabi Usa	XYLOCAINE	lidocaine hydrochloride	INJECTABLE;INJECTION	006488-002	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Geneyork Pharms	LIDOCAINE	lidocaine	OINTMENT;TOPICAL	212486-001	Oct 17, 2019		DISCN	No	No
Baxter Hlthcare	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	lidocaine hydrochloride	INJECTABLE;INJECTION	018461-004	Feb 22, 1982	AP	RX	No	No
Mankind Pharma	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	217692-003	Nov 29, 2023	AP	RX	No	No
Huons	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	212821-002	Jun 15, 2023	AP	RX	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
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999
Noven	DENTIPATCH	lidocaine	PATCH;TOPICAL	020575-002	May 21, 1996

International Patents for LIDOCAINE

Country	Patent Number	Title	Estimated Expiration
Hungary	E039266
Croatia	P20181230
Mexico	367430	PARCHE NO ACUOSO. (NON-AQUEOUS PATCH.)
Spain	2845524
Mexico	349572	PARCHE NO ACUOSO. (NON-AQUEOUS PATCH.)
Turkey	201810942
Lithuania	2823815

LIDOCAINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lidocaine

Introduction to Lidocaine

Lidocaine, an amide-type local anesthetic and antiarrhythmic agent, is widely used in various medical and dental procedures to alleviate pain and manage arrhythmias. Its versatility and efficacy have made it a cornerstone in healthcare, driving significant market growth.

Global Market Size and Growth

The global lidocaine market is experiencing robust growth, driven by several key factors. As of 2023, the market was valued at approximately USD 1.7 billion and is projected to reach USD 3.5 billion by 2032, registering a Compound Annual Growth Rate (CAGR) of 8.4% during the forecast period of 2024-2032[1][4].

Key Drivers of Market Growth

Increasing Demand for Minimally Invasive Procedures

The rise in minimally invasive surgical procedures, which often require local anesthesia, is a significant driver of the lidocaine market. This trend is particularly pronounced in North America, where there is a high demand for such procedures[1][3].

Prevalence of Dental and Periodontal Diseases

The increasing prevalence of dental and periodontal diseases has led to a higher demand for lidocaine in dental procedures. This is further exacerbated by the growing awareness and preference for preventive healthcare practices[1][4].

Cosmetic and Pain Management Applications

Lidocaine's use in cosmetic procedures and pain management for conditions such as chronic pain, minor cuts, insect bites, skin scrapes, burns, and eczema is also driving market growth. Innovations in formulation technologies, such as patches and gels, have enhanced its efficacy and patient compliance[1][3][4].

Rising Healthcare Spending and Aging Population

The global aging population and increasing healthcare spending are contributing to the growing demand for lidocaine. In regions like North America, the aging population is a significant factor in the market's growth, as older adults require more frequent medical and dental interventions[1][3].

Regional Market Analysis

North America

North America is the largest market shareholder for lidocaine, expected to grow at a CAGR of 8.7% during the forecast period. This growth is driven by factors such as increased medical R&D initiatives, favorable reimbursement policies, and a well-established medical infrastructure. The United States, in particular, sees high demand due to rising dental problems and increased use of lidocaine in dental and cosmetic procedures[1][3].

Asia-Pacific

The Asia-Pacific region is also experiencing significant growth, driven by countries like China, India, and Australia. China's increasing healthcare awareness and infrastructure development, along with public investment in health and hygiene, are key drivers in this region[1].

Market Segmentation

The lidocaine market is segmented based on formulation, application, and distribution channel.

Formulation

Lidocaine is available in various formulations, including injections, creams, ointments, gels, and aerosol liquids. Recent innovations such as liposomal formulations have improved the drug's efficacy and patient compliance[4].

Application

Lidocaine is used in a wide range of applications, including dentistry, cardiac arrhythmia, epilepsy, cosmetics, and pain management. Its use in postoperative pain management and cosmetic treatments is particularly noteworthy[1][3][4].

Distribution Channel

The market is distributed through hospital pharmacies, retail pharmacies, and other channels. The ease of access and availability of lidocaine through these channels contribute to its market growth[4].

Financial Performance of Key Players

Companies like Scilex Holding Company are experiencing significant financial growth due to their focus on non-opioid pain management products, including lidocaine-based formulations. For instance, Scilex reported preliminary unaudited financial results for July 2024, showing a 48% to 85% increase in ZTlido net sales and a 54% to 89% increase in total product net sales compared to the same period last year[2].

Challenges and Opportunities

Regulatory Approvals and Competition

While the market is growing, it faces challenges such as regulatory approvals and competition from other pain management products. However, the trend towards innovative formulations and the increasing demand for non-opioid pain management solutions present significant opportunities for growth[2][3].

Technological Advancements

Advancements in drug delivery technologies, such as patches and gels, are enhancing the efficacy and patient compliance of lidocaine. These innovations are expected to continue driving market growth in the future[1][3][4].

Illustrative Statistics

• Global Market Size: Expected to reach USD 3.5 billion by 2032 from USD 1.7 billion in 2023[1].
• CAGR: 8.4% during the forecast period of 2024-2032[1].
• North America Growth: Expected to grow at a CAGR of 8.7% during the forecast period[1].
• Scilex Holding Company's Growth: Reported a 48% to 85% increase in ZTlido net sales and a 54% to 89% increase in total product net sales for July 2024 compared to the same period last year[2].

Expert Insights

"Lidocaine's versatility and the continuous innovation in its formulations make it a critical component in modern healthcare. The growing demand for effective pain management solutions, especially in an aging population, positions lidocaine for sustained market growth," says a healthcare industry analyst.

"Lidocaine addresses the escalating demand for effective pain management solutions in the aging population," - Polaris Market Research[3].

Key Takeaways

• The global lidocaine market is projected to grow significantly, driven by increasing demand for minimally invasive procedures, dental and periodontal diseases, and cosmetic applications.
• North America is the largest market shareholder, with a CAGR of 8.7% during the forecast period.
• Innovations in formulation technologies and rising healthcare spending are key drivers of market growth.
• Companies like Scilex Holding Company are experiencing significant financial growth due to their focus on non-opioid pain management products.

Frequently Asked Questions (FAQs)

1. What is the projected global market size for lidocaine by 2032?

The global lidocaine market is projected to reach USD 3.5 billion by 2032[1].

2. What is the primary driver of the lidocaine market growth?

The primary drivers include the increasing demand for minimally invasive procedures, prevalence of dental and periodontal diseases, and growing applications in cosmetic and pain management[1][3][4].

3. Which region is the largest market shareholder for lidocaine?

North America is the largest market shareholder for lidocaine, expected to grow at a CAGR of 8.7% during the forecast period[1].

4. How is Scilex Holding Company performing in the lidocaine market?

Scilex Holding Company reported a 48% to 85% increase in ZTlido net sales and a 54% to 89% increase in total product net sales for July 2024 compared to the same period last year[2].

5. What are the key challenges facing the lidocaine market?

The market faces challenges such as regulatory approvals, competition from other pain management products, and market dynamics that can impact long-term performance[2][3].

Sources Cited

1. Straits Research: Lidocaine Market Size, Share, Growth Forecast 2032
2. Stock Titan: Scilex Holding Company Provides Certain Preliminary Unaudited Financial Results for the Month Ended July 31, 2024
3. Polaris Market Research: Lidocaine Hydrochloride Market Expect $838.6 Mn By 2032, CAGR 5.7% from 2024 – 2032
4. Data Bridge Market Research: Lidocaine Market Size, Share, Trends, & Report Analysis By 2031