LIDODERM Drug Patent Profile

When do Lidoderm patents expire, and when can generic versions of Lidoderm launch?

Lidoderm is a drug marketed by Teikoku Pharma Usa and is included in one NDA.

The generic ingredient in LIDODERM is lidocaine. There are twenty-nine drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the lidocaine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lidoderm

A generic version of LIDODERM was approved as lidocaine by ACTAVIS LABS UT INC on August 23^rd, 2012.

Summary for LIDODERM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	22
Patent Applications:	4,553
Drug Prices:	Drug price information for LIDODERM
What excipients (inactive ingredients) are in LIDODERM?	LIDODERM excipients list
DailyMed Link:	LIDODERM at DailyMed

See drug prices for LIDODERM

See drug sales revenues for LIDODERM

Recent Clinical Trials for LIDODERM

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

Sponsor	Phase
University of Iowa	Phase 4
Nicole K Brogden	Phase 4
Long Island University	Phase 4

See all LIDODERM clinical trials

Pharmacology for LIDODERM

Drug Class	Amide Local Anesthetic Antiarrhythmic
Physiological Effect	Local Anesthesia

Paragraph IV (Patent) Challenges for LIDODERM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LIDODERM	Topical Patch	lidocaine	5%	020612	1	2009-11-13

US Patents and Regulatory Information for LIDODERM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999	AB	RX	Yes	Yes

Expired US Patents for LIDODERM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999

International Patents for LIDODERM

See the table below for patents covering LIDODERM around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	69221848
Japan	H07265353	NONOBSTRUCTIVE ADHESIVE PATCH FOR APPLICATION OF MEDICINE ONSKIN
Denmark	0674913
Spain	2224102
Canada	2096744
World Intellectual Property Organization (WIPO)	9309211
Austria	157391

LIDODERM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lidocaine (Lidoderm)

Introduction to Lidocaine

Lidocaine, an amide-type local anesthetic and antiarrhythmic agent, is a cornerstone in modern healthcare. It is widely used in various medical and dental procedures to alleviate pain and manage arrhythmias. One of the well-known formulations of lidocaine is Lidoderm, a transdermal patch used primarily for the management of postherpetic neuralgia.

Global Market Size and Growth

The global lidocaine market, which includes formulations like Lidoderm, is experiencing robust growth. 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[3].

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[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. Growing awareness and preference for preventive healthcare practices further exacerbate this demand[3].

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[3].

Regional Market Dynamics

North America

North America dominates the lidocaine market, driven by factors such as an increase in the geriatric population, growing number of surgical procedures, and technological advancements in various surgical and aesthetic treatments. The North America lidocaine market is expected to grow at a CAGR of 9.20% from 2022 to 2030, reaching a valuation of USD 1340.34 million by 2030[4].

Financial Performance of Key Players

Scilex Holding Company

Companies like Scilex Holding Company, which focus on non-opioid pain management products, are experiencing significant financial growth. For example, Scilex 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[3].

Endo Pharmaceuticals

Endo Pharmaceuticals, another major player, has seen mixed results. While their Branded Pharmaceuticals segment revenues increased by 6% in the second quarter of 2024 compared to the same period in 2023, their Sterile Injectables and Generic Pharmaceuticals segments experienced declines. However, the company remains optimistic about future growth, particularly in the branded segment[2].

Challenges and Opportunities

Regulatory Approvals and Competition

The lidocaine market 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[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.

"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," - Healthcare industry analyst[3].

Market Segments and Applications

Lidoderm (Transdermal Patch)

Lidoderm, a transdermal patch formulation of lidocaine, is specifically used for the management of postherpetic neuralgia. This segment benefits from the overall growth in demand for effective pain management solutions, particularly among the aging population.

Dental and Cosmetic Procedures

The use of lidocaine in dental and cosmetic procedures is a significant segment of the market. The increasing prevalence of dental and periodontal diseases, along with the growing demand for aesthetic treatments, drives the demand for lidocaine in these applications[3].

Impact of Healthcare Spending and Aging Population

The rising healthcare spending and the increasing aging population are key drivers of the lidocaine market. As the population ages, the demand for effective pain management solutions, including lidocaine, is expected to increase[3].

Illustrative Statistics

• Global Market Size: Expected to reach USD 3.5 billion by 2032 from USD 1.7 billion in 2023[3].
• CAGR: 8.4% during the forecast period of 2024-2032[3].
• North America Growth: Expected to grow at a CAGR of 9.20% during the forecast period (2022-2030)[4].
• 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[3].

Expert Insights

"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 9.20% 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[3].

2. What are the primary drivers 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[3].

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 9.20% during the forecast period[4].

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[3].

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[3].

Sources

1. Grand View Research - Lidocaine Hydrochloride Market Size & Share Report, 2030[1].
2. ENDO Pharmaceuticals - ENDO REPORTS SECOND-QUARTER 2024 FINANCIAL RESULTS[2].
3. Drug Patent Watch - Generic LIDOCAINE INN entry, pharmaceutical patent expiration[3].
4. Straits Research - North America Lidocaine Market Outlook, Growth, Report to 2030[4].