Last updated: February 24, 2026
What is NDC 00781-3516?
The National Drug Code (NDC) 00781-3516 refers to Clemastine Fumarate Tablets 2 mg. This antihistamine is used primarily for allergy relief, including hay fever and allergic rhinitis.
Market Size and Demand Overview
- Historical sales data: The market for antihistamines has experienced steady growth, driven by increased prevalence of allergies. In 2022, antihistamine sales in the U.S. reached approximately $1.2 billion.
- Prescription and OTC status: Clemastine is available both over-the-counter (OTC) and via prescription. The OTC segment dominates, representing about 70% of the market share.
- Patient demographics: Primarily used by adults aged 18-65. Pediatric usage accounts for roughly 15% of prescriptions (IQVIA, 2022).
Competitive Landscape
| Brand Name |
Manufacturer |
Market Share |
Price Range (per 30 tablets) |
Notes |
| Tavist (Clemastine) |
Sandoz |
45% |
$8 - $12 |
Leading OTC brand |
| Generic (NDC 00781-3516) |
Multiple (e.g., Teva, Mylan) |
40% |
$5 - $10 |
Price-driven segment |
| Other brands |
Various |
15% |
$10 - $15 |
Prescription options |
- Generics have gained significant market penetration, reducing prices. The generic segment is cost-sensitive and competes primarily on price.
Pricing Dynamics and Trends
- Price decline: Since 2018, OTC antihistamines, including Clemastine, have seen prices decrease by approximately 20% due to generic competition.
- Regulatory influence: No recent FDA label changes or market-entry barriers for Clemastine. This supports pricing stability.
- Price projections: See below for forecast estimates.
Price Projection for 2023-2026
| Year |
Estimated Average Price (per 30 tablets) |
Range |
Comments |
| 2023 |
$7.50 |
$5 - $10 |
Slight decline, stabilized by generic competition |
| 2024 |
$7.00 |
$5 - $9 |
Continued price pressure, potential stabilization |
| 2025 |
$6.50 |
$5 - $8 |
Market stabilizes; new entrants unlikely |
| 2026 |
$6.00 |
$4 - $8 |
Slight decline, maintained by OTC sales |
Regulatory and Market Entry Barriers
- The OTC nature reduces regulatory hurdles, making market expansion easier.
- Existing high penetration limits growth potential.
- No significant patent protections for the generic formulation, fostering competition.
Key Trends Impacting Future Market Dynamics
- Increased allergy prevalence: Rising allergy cases—expected to grow at 4% annually—may sustain demand.
- Generic saturation: Price-sensitive consumers prefer generics, exerting downward pressure on prices.
- Potential new indications: Research into Clemastine for other conditions (e.g., demyelinating diseases) is in early stages, with limited immediate impact.
- Supply chain stability: Raw material sourcing remains stable, with minimal disruptions.
Summary
NDC 00781-3516, representing Clemastine Fumarate Tablets, operates in a mature, highly competitive OTC antihistamine market. The current price range for generics is $5-$10 per 30 tablets, with a downward trend driven by generic entry. Price projections indicate a gradual decline to about $6 per 30 tablets by 2026, reflecting market saturation and stable demand driven by allergy prevalence.
Key Takeaways
- The market for Clemastine Fumarate is mature with limited growth, primarily sustained by allergy prevalence.
- Generic competition dominates, pressuring prices downward.
- Prices are expected to decline gradually over the next three years.
- No major regulatory barriers or patent protections limit market entry for generics.
FAQs
1. How does the market size of Clemastine compare to other antihistamines?
It represents roughly 10-15% of the total OTC antihistamine market, with high competition from brands like loratadine and cetirizine.
2. Are there any anticipated regulatory changes affecting Clemastine?
No significant regulatory changes are expected in the immediate future, given its OTC status and established safety profile.
3. What factors could disrupt current pricing trends?
Introduction of new, more effective medications, regulatory restrictions, or supply chain disruptions could alter pricing.
4. How significant is off-label use for Clemastine?
Off-label use is limited; most applications are well-established for allergy relief.
5. What is the potential for brand-name Clemastine products to command higher prices?
Brand-name products currently command a premium of 20-30% over generics but face pressure from commoditization. Price premiums may persist if combined with marketing strategies or formulation differences.
References
[1] IQVIA. (2022). U.S. Over-The-Counter Medication Sales Data.
[2] MarketWatch. (2023). Antihistamine Market Trends and Forecasts.
[3] FDA. (2022). OTC Drug Review and Labeling Regulations.
[4] Statista. (2022). Over-the-counter antihistamine sales.
