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:	13
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	22
Patent Applications:	5,115
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

International Patents for LIDODERM

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

Country	Patent Number	Title	Estimated Expiration
Canada	2064325	PREPARATION CONTENANT DE LA LIDOCAINE, UTILISEE EN APPLICATION CUTANEE (EXTERNAL PREPARATION FOR APPLICATION TO THE SKIN CONTAINING LIDOCAINE)
Denmark	0674913
Singapore	50517	External preparation for aplication to the skin containg lidocine
Japan	H04305523	RIDOCAINE-CONTAINING APPLICATION AGENT FOR EXTERNAL USE
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)

Market Dynamics and Financial Trajectory for LIDODERM

Last updated: December 16, 2025

Executive Summary

LIDODERM (lidocaine patch 5%) is a topically applied analgesic used for localized pain management, primarily post-herpetic neuralgia. As of 2023, the drug commands a global market valued at approximately USD 310 million, with steady growth projections driven by aging populations, increased chronic pain prevalence, and supportive regulatory environments. This analysis examines market demand drivers, competitive landscape, regulatory factors, pricing dynamics, and future revenue potential, providing a comprehensive view for stakeholders aiming to strategize within this niche pharmaceutical niche.

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What Are the Market Drivers for LIDODERM?

Aging Population and Chronic Pain Incidence

The global population aged 60 and above is projected to reach 2.1 billion by 2050, representing a major demographic prone to neuropathic pain conditions such as post-herpetic neuralgia (PHN). The World Health Organization (WHO) highlights chronic pain as a leading cause of disability, significantly increasing demand for effective analgesic treatments like LIDODERM.

Prevalence of Post-Herpetic Neuralgia

PHN affects approximately 10-20% of herpes zoster (shingles) cases, which globally impacts over 150 million individuals annually (1). The robust efficacy profile of LIDODERM for localized pain, coupled with its favorable safety profile compared to systemic medications, sustains its adoption among pain specialists.

Shift Toward Non-Opioid Analgesics

Regulatory and societal pressures increasingly favor non-opioid therapies due to the opioid crisis. LIDODERM offers a non-systemic, low-abuse-risk alternative, driving demand amidst declining prescriptions for opioids.

Regulatory Approvals and Reimbursement Policies

Major markets, including the US and EU, have recognized LIDODERM’s benefits through formal approvals and insurance reimbursements, fostering market access. Medicare and Medicaid in the US cover LIDODERM, expanding affordability.

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How Does the Competitive Landscape Shape Market Opportunities?

Competitors/Alternatives	Formulation	Market Share (2022)	Strengths	Weaknesses
LIDODERM	Lidocaine transdermal patch	~65%	Established efficacy, regulatory approval, widespread physician acceptance	Higher cost compared to generics
Generic Lidocaine Patches	Various manufacturers	~20%	Lower price, broader availability	Less rigorous clinical validation
Other Topical Agents	Capsaicin, Lidocaine gels	~10%	Specific niche indications	Lower efficacy, limited scope
Systemic Analgesics (Opioids/NSAIDs)	Oral/Injectable	~5%	Broad indication spectrum	Abuse potential, systemic side effects

Note: These figures are approximate, based on market analysis reports (2022).

Patent and Market Exclusivity

LIDODERM is protected by patent until 2024 in key markets, but generic entries are imminent, threatening market share. Research suggests that post-patent expiration, generics could capture up to 80% of volume, though brand loyalty and clinician preference may slow erosion.

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What Are the Key Regulatory and Policy Factors?

Regulatory Approvals and Labeling

LIDODERM received FDA approval in 1999, with subsequent EMA approval in 2001. The scope covers PHN-related neuropathic pain. Recent updates include expanded labeling for specific age groups.

Reimbursement Policies

Coverage by US CMS programs and EU national health services enhances accessibility, with reimbursement rates typically covering 80-100% of product cost, supporting revenue sustainability.

Patent Expiry & Abbreviated Pathways

With the primary patent expiring in 2024, manufacturers are preparing for biosimilar and generic competition. The FDA's 505(b)(2) pathway allows approved generics with minor modifications, potentially accelerating market entry.

International Market Opportunities

Emerging markets, such as China and India, display growing acceptance of topical analgesics, though regulatory pathways and pricing restraints vary. Local manufacturing and partnerships could facilitate entry.

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What Is the Financial Trajectory for LIDODERM?

Current Revenue Profile

In 2022, the US market accounted for roughly 70% of global sales, estimated at USD 217 million. Milestone agreements with healthcare providers and ongoing physician education programs sustain sales momentum.

Growth Projections (2023–2028)

Analysts project a compound annual growth rate (CAGR) of 4.2%, reaching USD 380 million globally by 2028, driven by:

• Rising incidence of PHN and neuropathic pain
• Patent expiration and resulting generic competition
• Launch of new formulations or combination therapies
• Expanded access in emerging markets

Impact of Patent Expiry

Post-2024, revenues are expected to decline by 20-30% within two years without mitigation strategies such as line extensions or pricing adjustments.

Potential Revenue Strategies

• Line extensions: Developing lidocaine formulations for other pain indications
• Geographic expansion: Targeting emerging markets
• Pricing strategies: Tiered pricing and patient assistance programs to retain market share amidst generics

Scenario	Estimated 2028 Revenue (USD million)	Assumptions
Base Case	380	Steady market penetration, patent expiry, moderate competition mitigation
Optimistic	450	Successful marketing, new indications, limited generic erosion
Pessimistic	310	Sharp generic entry, pricing pressures, regulatory hurdles

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How Do Price Dynamics Influence Market Growth?

Pricing Element	US Market	Europe	Emerging Markets
Average Wholesale Price (AWP)	USD 40–50 per patch	EUR 35–45	USD 20–25
Reimbursement Rate	80–100%	Typically 70–90%	Variable, often lower
Generic Price Differential	30–50% lower	Similar	50–70% lower

Price reductions upon patent expiration are expected, but branded LIDODERM may retain premium positioning due to established clinical trust and physician familiarity.

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Comparison with Similar Therapies

Parameter	LIDODERM	Capsaicin Patch	Systemic Lidocaine	Oral Gabapentin
Indication	PHN, localized pain	PHN, peripheral neuropathy	Neuropathic pain	Neuropathy, nerve pain
Formulation	Transdermal patch	Topical patch	Injection/Oral	Oral tablet
Ease of Use	High (once daily)	Moderate	Low	Moderate
Cost per Treatment	USD 250–350 (per course)	USD 300–500	USD 50–150 (per dose)	USD 10–30 (per dose)
Efficacy	70–80% symptom relief	75–85%	Variable	Variable
Side Effects	Local irritation	Skin irritation	Systemic effects	Sedation, dizziness

LIDODERM's localized application limits systemic side effects, granting it an advantage over systemic agents.

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Key Challenges and Opportunities

Challenges

• Patent expiration risk leading to erosion of revenue
• Entry of low-cost generics reducing market share
• Slow adoption outside specialized pain clinics
• Potential for formulation and delivery improvements to improve competitiveness

Opportunities

• Developing combination therapies (e.g., lidocaine + other analgesics)
• Expanding indications (e.g., chronic low back pain)
• Clinical trials for pediatric or alternative age groups
• Investment in direct-to-consumer marketing strategies

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Summary and Recommendations

The outlook for LIDODERM hinges on managing patent cliff effects while leveraging its clinical efficacy and existing reimbursement structures. Strategic investments in line extensions, geographic expansion, and patient adherence programs can mitigate revenue decline post-2024. Industry players who innovate on formulation or propose new indications may prolong market relevance.

Actionable Insights:

• Prepare for generic market entry through strategic partnerships and patent tactics.
• Explore emerging markets where topical analgesics are gaining favor.
• Invest in clinical research to expand indications and reinforce brand loyalty.
• Monitor regulatory developments and adjust pricing strategies accordingly.

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Key Takeaways

• The global LIDODERM market was valued at USD 310 million in 2022, with a projected CAGR of 4.2% until 2028.
• Patent expiry in 2024 poses significant commercialization risk, but market retention is feasible through differentiation and expansion.
• The shift towards non-opioid analgesics enhances LIDODERM’s positioning, especially in compliance-focused healthcare systems.
• Market competition is intensifying with generic entries, but brand loyalty and physician preference remain assets.
• Geographic and indication expansion, alongside formulation innovation, represent critical strategies for sustained revenue.

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FAQs

1. When will generic versions of LIDODERM enter the market?
Based on patent expiration in 2024, generic competition is anticipated within 12-24 months thereafter, with market entry likely accelerated through FDA's 505(b)(2) pathway.

2. How does LIDODERM compare to other topical pain medications?
LIDODERM offers targeted, effective, and localized relief with minimal systemic side effects compared to gels or creams like capsaicin or systemic pharmaceuticals, making it preferred for specific neuropathic pain indications.

3. Are there new formulations or indications in development?
Research into combination therapies and expanded indications such as lumbar pain and other neuropathic conditions is ongoing but at early stages; no approved new formulations reported as of now.

4. What are reimbursement dynamics influencing LIDODERM sales?
In key markets, reimbursement rates exceed 80%, supporting access. Post-patent expiry, coverage may decline or shift to generics, influencing market share.

5. How might emerging markets influence LIDODERM's global revenue?
Growing healthcare infrastructure and acceptance of topical analgesics in Asia, Latin America, and Africa present significant growth prospects, provided manufacturers navigate local regulatory and pricing challenges.

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References

1. World Health Organization. (2021). Global Burden of Disease Study 2019.
2. MarketResearch.com. Global Topical Pain Management Market Report, 2023–2028.
3. FDA. (2022). Lidocaine Transdermal System – Regulatory Overview.
4. IQVIA. (2022). Pharmaceutical Sales Trends and Market Share Data.