Last updated: February 21, 2026
What is NDC 68180-0875?
NDC 68180-0875 refers to a specific drug product registered in the U.S. National Drug Code system. It is marketed as LORASTA (loratadine) 10 mg tablets. Loratadine is an antihistamine widely used for allergy relief.
Market Overview
Current Market Size
- The U.S. antihistamine market, including loratadine, was valued at approximately $1.2 billion in 2022 according to IQVIA data.
- Loratadine accounts for about 30-35% of this segment, translating to around $420-$420 million annually.
- The market experiences steady growth at approximately 3-4% compounded annually.
Competition Landscape
- Major competitors include Claritin (Merck/Schering-Plough), Allegra (Sanofi), and Zyrtec (Pfizer).
- Claritin controls about 60-65% of the loratadine market.
- Generic loratadine products, including the drug with NDC 68180-0875, account for 35-40% of sales**.
Regulatory and Market Trends
- The FDA approved OTC status for loratadine in 1998.
- Recent trends include increased demand for OTC allergy medications due to allergy prevalence and consumer preference.
- Patent expirations for brand products occurred decade ago, increasing generic market share.
- New formulations or combination products may influence future sales dynamics.
Price Analysis
Current Price Point
- The average wholesale price (AWP) for a 30-tablet box of loratadine 10 mg ranges between $15 and $20, depending on wholesaler negotiations.
- Retail prices are typically $25 to $30 per box for branded Claritin, while generics average $15 to $20.
Price Differentials
| Product Type |
Average Wholesale Price (AWP) |
Retail Price |
| Brand (Claritin) |
$15-$20 per 30-count |
$25-$30 |
| Generic (Loratadine 10 mg) |
$5-$10 per 30-count |
$10-$15 |
Price Projection Methodology
Projection factors include:
- Patent expiration impacts
- Competition from generics
- Market penetration of private label and new formulations
- Price sensitivity of consumers
- Potential policy/regulatory changes
Short-term (Next 2 Years)
- The generic loratadine product with NDC 68180-0875 is expected to maintain prices around $5 to $8 wholesale.
- Retail pricing is anticipated to stay within $10 to $15 per 30-count box.
- Competitive pressures from other generics could push prices lower by up to 10%.
Medium-term (3–5 Years)
- Market entry of potential new formulations or combination products may influence price erosion.
- Price competition is likely to sustain wholesale prices below $6.
- Retail prices may decline to $10 or lower, especially if large pharmacy chains promote discounts or private label options.
Long-term (5+ Years)
- Pricing stability will depend on market share retention against competitors.
- Market saturation and generic proliferation typically lead to price decreases of 10-20% from current levels.
- Price floors are expected around $4-$5 wholesale, with retail prices potentially stabilizing at $8-$10.
Revenue Projections
Assuming sales of 10 million units annually:
| Scenario |
Wholesale Revenue |
Retail Revenue |
Total Revenue |
| Conservative (7 million units at $5 wholesale) |
$35 million |
- |
$35 million |
| Aggressive (10 million units at $8 wholesale) |
$80 million |
- |
$80 million |
For a product with NDC 68180-0875, the revenue potential remains substantial if market share is maintained or increased.
Regulatory Factors Impacting Market
- No recent patent protection; generic entry is established.
- Future label expansions or REMS (Risk Evaluation and Mitigation Strategies) could influence sales flow.
- Potential regulatory changes regarding OTC status or labeling could impact pricing and market penetration.
Market Entry and Expansion Strategies
- Leveraging cost leadership via private label branding.
- Partnering with pharmacy chains for exclusive rights.
- Developing new combination products or formulations to differentiate.
Summary
| Aspect |
Details |
| Market Size |
~$420 million annually for loratadine segment in US |
| Price Trends |
Wholesale prices remain below $8; retail around $15 |
| Competitive Dynamics |
Dominated by generic products and existing brand leaders |
| Projection |
Wholesale prices likely to remain stable or decline slightly due to market saturation |
Key Takeaways
- NDC 68180-0875's generic loratadine product is positioned within a mature, competitive market.
- Prices are expected to decline gradually over five years, influenced by market saturation and competition.
- Revenue potential depends on market share, with conservative estimates around $35-$80 million annually.
- Strategic moves include private label branding, market expansion, and optional combination formulations.
- Regulatory and market trends favor sustained generic growth and price stability.
5 FAQs
1. What is the significance of patent expiration for NDC 68180-0875?
Patent expiration facilitates generic competition, leading to price reductions and increased market share for generic versions.
2. How do current prices for this drug compare to branded alternatives?
Generic loratadine prices are approximately 50-60% lower than branded Claritin, influencing consumer choice and market share.
3. What factors could accelerate price declines?
Entry of new lower-cost generics, increased market penetration, and pharmacy discount programs.
4. Is there potential for market growth for this NDC product?
Growth depends on market share retention and the introduction of new formulations or combination products.
5. Will regulatory changes impact the market for loratadine?
Yes, potential updates to OTC labeling and formulations could impact sales and pricing strategies.
References
- IQVIA. (2023). U.S. Prescription Drug Market Insights.
- FDA. (2022). OTC Drug Product Labeling.
- MarketWatch. (2023). Allergy Medication Market Analysis.
- Pharmaceutical Commerce. (2022). Generic Drug Pricing Trends.
- Statista. (2023). US Allergy Market Revenue Forecasts.
