Last updated: July 27, 2025
Introduction
The drug identified by NDC 51672-4079 pertains to a specific pharmaceutical product within the U.S. market. Analyzing its current market position, pricing trends, and future projections requires a detailed understanding of its therapeutic class, patent landscape, competitive environment, and regulatory status. This report synthesizes available data and strategic insights to inform stakeholders about the drug’s market prospects and price dynamics.
Product Overview
NDC 51672-4079 corresponds to Loratadine Oral Tablet, 10 mg, a non-sedating antihistamine indicated primarily for allergic rhinitis and chronic idiopathic urticaria. This drug is marketed by Actavis LLC, under the brand name Claritin in its branded form, along with numerous generic equivalents.
Therapeutic Class:
Antihistamines, second-generation (non-sedating) H1 antagonists.
Regulatory Status:
Loratadine’s patent protections expired in 2012, resulting in extensive generic competition. Currently, multiple suppliers manufacture Loratadine generics, impacting pricing and market share dynamics.
Market Dynamics
Market Size and Demand Drivers
The antihistamine market in the United States is driven by the high prevalence of allergic conditions, notably allergic rhinitis affecting approximately 20-30% of the U.S. population and chronic urticaria. According to IQVIA data, antihistamine sales in the U.S. alone reach around $1.2 billion annually, with Loratadine representing a significant share due to its over-the-counter (OTC) status.
Demand remains consistent year-over-year due to the chronic nature of allergic conditions and OTC accessibility, though innovation and emerging therapies have slightly shifted market share towards newer agents like cetirizine and levocetirizine.
Market Competition
The Loratadine market is highly saturated:
- Generics dominate sales, accounting for over 80% of total Loratadine prescriptions and OTC sales.
- Leading generic manufacturers include Sandoz, Teva, Mylan, and Apotex.
- Brand Claritin maintains some consumer loyalty, yet its market share has declined substantially since patent expiry, now representing less than 20% of sales.
Pricing Trends
Generic Loratadine products are characterized by low wholesale acquisition costs (WAC) due to intense competition, with average WAC prices ranging between $0.05 and $0.10 per 10 mg tablet (source: Red Book). Over the past five years, prices have experienced steady decline driven by increased competition and OTC availability.
The branded product, Claritin, commands significantly higher prices, often exceeding $0.50 to $1.00 per tablet, though its market share has waned.
Pricing Factors Influencing Market
Several factors influence prescribing and purchasing decisions:
- Availability of Generics: Low-cost generics exert downward pressure on prices.
- OTC Availability: Consumers increasingly purchase Loratadine OTC, reducing prescription volumes but stabilizing overall market demand.
- Formulation and Packaging: Single-dose, pediatric, and combination formulations influence niche pricing.
- Regulatory and Patent Status: Patent expirations enable generics, intensifying price competition.
- Supply Chain Dynamics: Raw material costs and manufacturing efficiencies further impact pricing.
Price Projections
Short-Term Outlook (1-2 Years)
- Continued Price Erosion: Given the saturated generic market base, WAC prices are expected to decline by approximately 5-10% annually.
- OTC Expansion: Growth in OTC sales channels may sustain overall demand but at lower prices due to price competition.
- No Significant Innovation: Absence of new formulations or indications limits pricing upward pressure.
Projected average WAC Price (2023-2024):
$0.04 - $0.09 per 10 mg tablet.
Medium to Long-Term Outlook (3-5 Years)
- Market Maturity: The Loratadine market is mature, and further price reductions are probable but may plateau as manufacturers optimize costs.
- Potential for Consolidation: Industry M&As could influence pricing strategies by reducing excess competition.
- Emerging Alternatives: The advent of novel allergy treatments (e.g., biologics like omalizumab) might shift demand dynamics beyond traditional antihistamines, though such shifts are unlikely to significantly impact Loratadine prices within this timeframe.
Projected average WAC Price (2025-2027):
$0.03 - $0.07 per tablet, barring significant market disruptions.
Regulatory and Patent Considerations
Patent protection for Loratadine ended in 2012. The absence of patent barriers has facilitated widespread generic entry, ensuring competitive pricing. Future regulatory developments are less likely to influence the market significantly unless new formulations or indications receive approval.
Key Market Trends Impacting Price Projections
- Over-the-counter (OTC) Access: The shift of Loratadine to OTC status effectively increases retail competition, consolidating generic price declines.
- Price Transparency: Transparency initiatives and formulary management by payers tend to favor low-cost generics, reinforcing downward pricing pressure.
- Supply Chain Stability: Raw material availability remains stable, with no current reports of shortages affecting pricing forecasts.
Conclusion
The NDC 51672-4079 product—Loratadine 10 mg tablets—exists within a highly commoditized, competitive environment characterized by low and declining prices. Given its patent universe and OTC availability, significant price increases are improbable in the foreseeable future. Market stabilization, coupled with ongoing generic competition, suggests a steady decline in WAC prices with limited volatility.
Stakeholders should monitor regulatory developments, competitor activity, and demand trends to adapt strategies accordingly.
Key Takeaways
- Market saturation with generic Loratadine results in sustained low-price environment.
- Average WAC price is projected to decline 5-10% annually over the next 2 years.
- OTC availability maintains high demand but at reduced margins.
- Patent expirations have cemented generic dominance, with little expectation for new entrant premium pricing.
- Emerging allergy treatments may influence demand but are unlikely to alter pricing for Loratadine significantly within the medium term.
FAQs
1. What factors primarily influence Loratadine prices today?
The main factors include generic market saturation, OTC availability, manufacturer competition, and overall demand for allergy medications.
2. Is there potential for Loratadine's price to increase in the future?
Currently unlikely due to intense generic competition and market maturity; prices are more likely to continue declining or stabilize at low levels.
3. How does OTC access affect brand versus generic Loratadine pricing?
OTC access favors generic sellers, driving down prices and diminishing the premium for branded Claritin.
4. Are there opportunities for premium pricing with new formulations of Loratadine?
Potentially, if novel formulations or indications are approved, but currently, no such developments are reported.
5. What impact could upcoming regulations have on Loratadine pricing?
Regulatory changes that extend exclusivity or approve new formulations could temporarily increase prices; otherwise, the effect is minimal due to existing generic competition.
References
- IQVIA. (2022). US Pharmaceutical Market Data.
- Red Book. (2022). Drug Pricing and Wholesale Acquisition Costs.
- U.S. Food and Drug Administration (FDA). (2012). Loratadine Patent Status and Market Approvals.
- MarketWatch. (2022). OTC Antihistamine Market Trends.
