Last updated: March 25, 2026
What is the Drug Identified by NDC 00071-0806?
NDC 00071-0806 corresponds to Lidocaine Topical Patch 700 mg. It is a local anesthetic used primarily for post-herpetic neuralgia. The patch delivers lidocaine through the skin over an extended period, providing sustained pain relief.
Current Market Size and Demand
Global Market Overview
The topical analgesic market, including lidocaine patches, is growing at a compound annual growth rate (CAGR) of 7% globally, projected to reach $4.0 billion by 2028 from $2.6 billion in 2022 [1].
US Market Specifics
- Market Size (2022): The US account for approximately 50% of global sales, equating to an estimated $1.3 billion.
- Key Players:
- Endo Pharmaceuticals
- Heron Therapeutics (Lidocaine 700 mg patches)
- Generic manufacturers
Usage Trends
- Increasing prevalence of post-herpetic neuralgia, especially in patients aged 60 and above.
- Growing preference for non-opioid pain management therapies.
- Expansion of indications to off-label uses such as localized neuropathic pain.
Market Drivers and Barriers
Drivers
- Aging population leading to increased cases of shingles and post-herpetic neuralgia.
- Rising awareness of non-opioid therapy options.
- Favorable reimbursement policies for topical analgesics in several regions.
Barriers
- Competition from oral and injectable analgesics.
- Patent expirations of branded formulations.
- Regulatory hurdles for generic label approval.
Pricing Analysis
Current Price Range
- Brand-name (e.g., Lidoderm): Average wholesale price (AWP) of approximately $250–$350 per 30 patches.
- Generics: Priced around $150–$250 per 30 patches, reflecting market entry recent generics.
Price Trends
- The branded product, Lidoderm, has seen slight price reductions over the past three years (~5% annually).
- Generics price competition has driven prices down by approximately 15–20% since 2020.
Cost Factors
- Manufacturing costs are primarily driven by patch delivery technology, with margins narrowing due to increased generic competition.
- Reimbursement rates vary, with Medicare and private insurers often negotiating lower rates.
Price Projections (2023–2028)
Assumptions
- Continued growth in demand driven by aging demographics.
- Ongoing generic entry lowering prices.
- Stable regulatory environment with no major patent litigations.
Projections
| Year |
Estimated Market Size (USD) |
Average Price per 30 patches (USD) |
Expected Revenue (USD) (based on 20 million patches sold annually) |
| 2023 |
$1.4 billion |
$200 |
$133 million |
| 2024 |
$1.5 billion |
$190 |
$142 million |
| 2025 |
$1.6 billion |
$180 |
$152 million |
| 2026 |
$1.8 billion |
$170 |
$163 million |
| 2027 |
$2.0 billion |
$160 |
$174 million |
| 2028 |
$2.2 billion |
$150 |
$186 million |
These projections account for increased competition, market expansion, and price erosion due to generics.
Competitive and Regulatory Landscape
- Patent Status: The original patent for Lidoderm expired in 2018. Multiple generics are now approved.
- Regulatory Pathways: Abbreviated New Drug Application (ANDA) pathway facilitates generic entry.
- Market Competition: The market is saturated with several approved generics, exerting downward pressure on prices.
Key Takeaways
- The market for lidocaine patches, including NDC 00071-0806, is growing due to demographic trends and increased awareness of non-opioid options.
- Prices have declined sharply following generic entry, with further erosion expected.
- Revenue projections suggest steady growth in the total market size but declining average prices.
- Competition remains fierce, and patent expirations will continue to influence pricing and market dynamics.
FAQs
What factors influence the price of lidocaine patches?
Reimbursement policies, generic competition, manufacturing costs, and regulatory approvals impact pricing.
How does competition affect the market share of NDC 00071-0806?
Market share dwindles as multiple generics enter, creating downward price pressure and forcing branded formulations to lower prices or reposition.
Are there any upcoming regulatory changes affecting this market?
Regulatory shifts are not anticipated to significantly impact current dynamics but could alter approval pathways or reimbursement policies.
What is the outlook for new entrants?
Market saturation limits profitability, but smaller companies focusing on niche indications or novel delivery systems may find opportunities.
How do reimbursement policies impact market penetration?
Higher reimbursement rates increase access and sales, while lower or restrictive reimbursements hinder adoption.
References
[1] Grand View Research. (2022). Topical Pain Management Market Size, Share & Trends Analysis Report. https://www.grandviewresearch.com/industry-analysis/topical-pain-management-market
