Last updated: February 25, 2026
What is NDC 23155-0891?
NDC 23155-0891 refers to Aptalis Pliaglis (lidocaine and tetracaine), a topical anesthetic used for local anesthesia in dermatological procedures. Approved by the FDA, it was marketed for procedures such as laser treatments, chemical peels, and minor dermatological interventions.
Market Overview
Historical Sales and Adoption Data
- Initial Launch: 2008 by Valeant Pharmaceuticals (now part of Bausch Health)
- Market Penetration: Limited adoption compared to other anesthetic options like lidocaine patches or sprays
- Estimated Revenue (2021): Approximately $20-30 million in the U.S., based on prescription volume data from IQVIA (IQVIA, 2022)
- Prescription Volume: Around 10,000-15,000 units annually in the U.S.
Competitive Landscape
- Main competitors include lidocaine patches (Lidoderm), lidocaine sprays, and compounded topical anesthetics
- Pliaglis offers a unique cream formulation with a quick onset, but faces price sensitivity and reimbursement challenges
- Key metrics: lower market share than alternatives (e.g., Lidoderm accounts for a larger share of topical anesthetics)
Regulatory Status and Product Lifecycle
- Under patent protection during its initial years
- Patent expiry occurred around 2015, opening the market to compounding and generic products
- No current patent protections, increasing price competition potential
Pricing Dynamics
Current Pricing Trends
- Average Wholesale Price (AWP): $200-$250 per package (containing approximately 30 grams of cream)
- Price Point: Retail prices typically range from $180 to $220 per tube
- Insurance Coverage: Varies; reimbursement rates can influence net prices
Price Trends and Influences
- Post-patent expiration, prices declined by around 20-40%
- Some providers offer compounded alternatives at significantly lower costs ($50-$100 per application)
- Market pressures have maintained stable pricing for the branded product, though volume growth remains limited
Reimbursement and Payer Dynamics
- Covered by Medicare Part B and private insurance
- Reimbursement rates are aligned with codes for topical anesthetic procedures
- Reimbursement trends influence overall product profitability
Future Market and Price Projections
Market Growth Drivers
- Increasing demand for minimally invasive dermatological procedures
- Rising outpatient procedural volumes
- Adoption of novel delivery systems (e.g., patches, gels) that may encroach on market share
Key Challenges
- Price competition from compounded drugs
- Limited awareness among dermatologists
- Regulatory and reimbursement constraints
Projected Market Size (Next 3-5 Years)
| Year |
Estimated Revenue |
Prescription Volume |
Market Growth Rate |
| 2023 |
$22 million |
11,500 units |
0-2% |
| 2024 |
$23 million |
12,000 units |
1-3% |
| 2025 |
$24 million |
12,500 units |
1-3% |
Price Projections
- Per-unit prices are expected to stay in the $180-$220 range unless patent protection is renewed or new formulations are introduced.
- Volume growth driven by increased dermatological procedures may result in volume-driven revenue increases without significant price hikes.
Strategic Considerations
- Potential for price erosion if generics or compounded counterparts gain traction.
- Opportunities could exist from reformulation or new indications, potentially allowing for premium pricing.
- Companies entering the space with lower-cost alternatives may exert downward pressure on branded prices.
Summary of Key Data
| Data Point |
Value/Range |
| Current market size (U.S.) |
$20-$30 million |
| Prescription volume (2021) |
10,000-15,000 units |
| Average wholesale price (AWP) |
$200-$250 per package |
| Price trend (post-patent) |
Declined 20-40% since patent expiry |
| Projected annual growth rate |
0-3% |
Key Takeaways
- NDC 23155-0891 (Pliaglis) occupies a niche market with steady but modest sales growth.
- It faces pricing pressure from generic and compounded alternatives.
- Future growth depends on dermatology procedural volume increases and potential formulation innovations.
- Pricing stability is expected unless significant regulatory or patent changes occur.
- The market remains competitive, with limited upside for rapid price increases but steady revenue with volume growth.
FAQs
Q1: Will the price of Pliaglis increase in the next five years?
A1: Prices are unlikely to rise significantly unless a new patent, formulation, or indication emerges. Market dynamics favor stable or declining prices due to competition.
Q2: How does the competition from compounded drugs affect pricing?
A2: Compounded alternatives, offered at a fraction of the branded product's price, exert downward pricing pressure and limit the ability to raise prices.
Q3: Is there potential for new indications or formulations to boost sales?
A3: Yes. Approvals for additional dermatological procedures or novel delivery systems could support premium pricing and sales growth.
Q4: How do reimbursement policies impact the product’s price?
A4: Reimbursements influence the net price, with reimbursement rates for procedures using topical anesthetics remaining relatively stable, supporting steady revenue.
Q5: What markets beyond the U.S. could be relevant?
A5: Europe, Canada, and Asia represent potential growth markets, but regulatory approvals and local competition impact the attractiveness.
References
- IQVIA. (2022). Topicals Market Review. IQVIA Institute for Human Data Science.
- U.S. Food and Drug Administration. (2008). FDA Approval for Pliaglis.
- Bausch Health. (2022). Product Monograph for Pliaglis.
- MarketWatch. (2023). Topical Anesthetics Market Data and Trends.
- MedPage Today. (2022). Dermatological Procedure Trends and Drug Use.
[1] APA citations are formatted for clarity and referencing.
