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-three 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:	13
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	22
Patent Applications:	4,203
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
Nicole K Brogden	Phase 4
Long Island University	Phase 4
University of Iowa	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	5,601,838
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999	5,411,738
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999	5,709,869
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999	5,827,529
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999	5,589,180
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999	5,741,510
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999	5,441,738

International Patents for LIDODERM

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

Country	Patent Number	Title	Estimated Expiration
Austria	149351
Germany	69433859
European Patent Office	0507160	Préparation à usage externe pour application sur la peau à base de lidocaine (External preparation for application to the skin containing lidocaine)
Denmark	0388306
Canada	2133598	PANSEMENT ADHESIF NON OCCLUSIF POUR L'ADMINISTRATION DE MEDICAMENTS SUR LA PEAU (NON-OCCLUSIVE ADHESIVE PATCH FOR APPLYING MEDICATION TO THE SKIN)
Germany	69221848
Japan	H02300138	TREATMENT FOR PAIN RELATING TO HERPES ZOSTER AND POSTHERPETIC NEURALGIA THROUGH LOCAL AP- PLICATION OF LOCAL ANESTHETIC

Market Dynamics and Financial Trajectory for LIDODERM

Last updated: October 15, 2025

Introduction

LIDODERM (lidocaine topical patch 5%) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of postherpetic neuralgia (PHN), a chronic pain condition following shingles. Since its debut, LIDODERM has established a distinctive niche within the topical analgesic market, driven by evolving pain management paradigms, regulatory considerations, and competitive landscape shifts. This report analyzes key market dynamics influencing LIDODERM’s trajectory and reviews the financial factors shaping its outlook.

Market Overview

Pharmaceutical Landscape for Pain Management

The global pain management market is projected to surpass $80 billion by 2027, fueled by increasing prevalence of chronic pain conditions, aging populations, and a rising preference for non-opioid therapies due to opioid misuse concerns. Topical anesthetics and patches constitute a significant segment, with formulations like LIDODERM serving as non-invasive alternatives to systemic analgesics.

Target Disease Incidence and Prevalence

Postherpetic neuralgia predominantly affects adults over 50, with an estimated lifetime incidence of 10-20% following shingles outbreaks [1]. With shingles incidence increasing due to aging demographics and immunosuppression, demand for effective PHN treatments, including LIDODERM, scales accordingly.

Market Penetration and Adoption Factors

Despite its approval in 1999, LIDODERM’s market share remains modest compared to oral analgesics owing to factors including physician prescribing habits, patient preferences, and reimbursement policies. However, growing awareness of opioid alternatives and topical therapies enhances its utilization.

Market Dynamics

Regulatory Environment

Regulatory frameworks influence market favorability. LIDODERM’s approval pathway was aligned with FDA standards for topical analgesics. Recent regulatory emphasis on opioid reduction benefits topical treatments like LIDODERM, encouraging prescriber adoption as opioid-sparing agents [2]. Conversely, regulatory scrutiny on compounded topical drugs and off-label use could impose constraints.

Competitive Landscape

LIDODERM faces competition from other topical analgesics, including capsaicin patches, compounded lidocaine formulations, and emerging therapies such as nerve growth factor inhibitors. Notably, capsaicin patches have gained traction due to their prolonged duration of action and high-dose formulations.

Pharmaceutical companies have introduced generic lidocaine patches, which exert downward pressure on pricing and profit margins for branded LIDODERM. Nevertheless, LIDODERM’s established brand recognition and patent exclusivity until 2026 provide a temporary market advantage.

Pricing and Reimbursement Policies

Reimbursement strategies significantly impact revenue streams. LIDODERM benefits from coverage under Medicare and private insurers, yet copayment obligations and formulary positioning influence patient access. Price erosion due to generics, combined with managed care policy shifts, constrains profit margins but sustains volume sales.

Technological and Therapeutic Innovations

Advancements such as extended-release patches and combination topical formulations could threaten LIDODERM’s market position. However, clinical integration of LIDODERM within multimodal pain management protocols sustains its relevance.

Patient Preferences and Prescriber Trends

Increasing preference for minimally invasive, opioid-sparing options bolsters LIDODERM’s utilization. The COVID-19 pandemic further accentuated demand for outpatient, non-systemic pain therapies, positively impacting its market dynamics.

Financial Trajectory

Revenue Projections

Marketers project that LIDODERM's revenues will experience moderate growth over the next five years, driven largely by:

• The rising elderly population with PHN.
• Growing physician awareness of non-opioid options.
• Expansion into underserved markets due to improved insurance coverage.

However, revenue growth will likely be tempered by patent expiration in 2026, which could facilitate generic entry and price erosion.

Profitability and Cost Considerations

Branded LIDODERM commands premium pricing relative to generics, supporting better margins pre-patent expiry. Post-patent loss may lead to substantial margin compression unless differentiated by formulation innovation or brand loyalty.

Pipeline and Developmental Outlook

Current pipelines lack direct replacements for LIDODERM; however, innovations in topical analgesics and alternative delivery systems could fragment market share further.

Regulatory and Patent Milestones

Patent expiry in 2026 marks a pivotal point. Manufacturers are exploring reformulations and new indications to extend exclusivity, with the success of such strategies impacting future financial trajectories.

Global Market Expansion

Emerging markets with aging demographics and limited access to systemic pain therapies present opportunities. Navigating regulatory hurdles and reimbursement landscapes remains crucial for international growth.

Key Market Drivers and Constraints

Drivers	Constraints
Aging population and PHN prevalence	Patent expiry leading to generic competition
Shift toward non-opioid pain management	Pricing pressures from generics
Reimbursement policies favoring topical analgesics	Regulatory shifts affecting formulation approval
Physician and patient preference for non-invasive options	Limited pipeline innovations for LIDODERM-specific technology

Conclusion

LIDODERM's market dynamics are shaped by demographic trends, regulatory policies, competitive innovations, and reimbursement mechanisms. While current revenue streams are stable, imminent patent expiration and evolving therapeutic alternatives necessitate strategic adaptation. Its financial trajectory hinges on diversification, reformulation efforts, and market expansion, especially within aging and underserved populations.

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Key Takeaways

• The aging demographic and increasing PHN prevalence underpin sustained demand for LIDODERM.
• Patent expiration in 2026 presents significant generic competition, pressuring prices and margins.
• Strategic innovation and pipeline development are vital to extend LIDODERM’s market lifespan.
• Adoption depends on physician preference shifts towards opioid-sparing, minimally invasive pain therapies.
• Global expansion offers growth opportunities but demands navigating regulatory and reimbursement complexities.

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FAQs

1. What is the primary therapeutic benefit of LIDODERM?
LIDODERM provides localized, non-invasive relief from postherpetic neuralgia pain by delivering lidocaine directly through the skin, minimizing systemic exposure and associated side effects.

2. How will patent expiration in 2026 affect LIDODERM’s market share?
Patent expiry will enable generic manufacturers to enter the market, likely leading to significant price reductions, decreased revenue for the branded product, and increased competition.

3. Are there ongoing developments to extend LIDODERM’s market exclusivity?
Manufacturers are exploring reformulations, new indications, or combination therapies, aiming to extend patent life or introduce premium formulations.

4. How does reimbursement impact LIDODERM’s adoption?
Reimbursement policies influence patient access; favorable coverage fosters higher prescription rates, while copayment or formulary restrictions can hinder utilization.

5. What emerging therapies threaten LIDODERM’s market position?
Capsaicin patches, nerve growth factor inhibitors, and systemic non-opioid analgesics are competitors that could displace LIDODERM depending on efficacy, safety, and cost profiles.

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References

[1] Johnson, R., & Rice, A. S. (2014). Postherpetic Neuralgia. New England Journal of Medicine, 371(16), 1526–1533.
[2] U.S. Food and Drug Administration (FDA). (2020). Regulatory Policies for Non-Opioid Pain Medications.