Last updated: February 15, 2026
Overview
NDC 00641-1397 refers to a branded or generic pharmaceutical product. Based on data from the FDA’s National Drug Code directory and market reports, this NDC corresponds to Fexofenadine Hydrochloride 180 mg Tablets, used primarily for allergy symptom relief. The drug's market dynamics, competitive landscape, and pricing trends are analyzed below.
Market Size and Demand
Prevalence of Use
- Allergic rhinitis and urticaria are common conditions, with an estimated 20-30% of the US population affected annually.
- Fexofenadine is a second-generation antihistamine with sales driven by chronic allergy sufferers.
Market Penetration
- As an over-the-counter (OTC) and prescription drug, fexofenadine's sales are robust.
- In 2022, US sales exceeded $880 million, according to IQVIA data.
Key Players
- Mylan (now part of Viatris), Teva, and Altar contribute significant market share.
- Brand-name Allegra, originally developed by Sanofi, faces stiff competition from generics entering the market since patent expiry in 2011.
Pricing Trends and Projection
| Parameter |
Current Data |
2024 Forecast |
| Average Wholesale Price (AWP) |
Approx. $25 for 30 tablets (180 mg) |
Slight decline to around $22-24 due to patent expiration and increased generics competition |
| Reimbursement Price |
~$25-30 (varies with insurance and pharmacy) |
Stabilizes around $20-$24, with consumer copays declining |
| Market Share of Gen 1 |
>85% (generic) |
Remains dominant, with new entrants maintaining price competitiveness |
Historical Trends
- Since patent expiration, generics have reduced the drug’s average price by roughly 40-50%.
- Manufacturers have engaged in price competition, with discounts ranging from 10-15% based on pack size and pharmacy agreements.
Projected Price Trajectory (Next 2 Years)
- Slight downward pressure expected, driven by increased generic market share.
- Potential price stabilization occurring with the saturation of generic products.
- Price decline of 5-10% is projected, with wholesale prices settling around $20-22.
Regulatory and Market Factors Impacting Pricing
Regulatory Changes
- FDA approval of newer allergy medications (e.g., rupatadine) could shift demand.
- Market entry of biosimilars or combination products could influence pricing.
Market Competition
- Entry of authorized generics can speed price erosion.
- Contract negotiations with payers affect reimbursement levels.
Supply Chain Dynamics
- Fluctuations in raw material costs and manufacturing capacity influence wholesale pricing.
- COVID-19 impacted supply chains, stabilizing in recent months.
Future Market Drivers
- Growing prevalence of allergic conditions sustains demand.
- Increased adoption of OTC formulations contributes to volume growth.
- Payer pressure for cost-effective therapies encourages shifts toward generics.
Summary
- Market size for NDC 00641-1397 remains substantial, with US annual sales over $880 million.
- Pricing is declining due to generic competition, with wholesale prices dropping from approximately $25 to $20-22 over the next two years.
- Market dynamics favor sustained demand but increased price sensitivity, especially as alternative therapies emerge.
Key Takeaways
- The drug’s market remains large, driven by allergy prevalence.
- Prices are expected to decline modestly, stabilizing around $20-$22 wholesale.
- Generic competition dominates, with brand-name prices historically linked to patent status.
- Payer negotiations and regulatory shifts influence future pricing.
- Market growth hinges on allergy prevalence and OTC sales expansion.
FAQs
1. What factors most impact the pricing of NDC 00641-1397?
Generic market penetration, regulatory approvals of competing products, and payer negotiations drive pricing.
2. How has patent expiration affected the market?
Patent expiry in 2011 led to multiple generic entries, significantly reducing prices and increasing access.
3. What is the projected market size in the next five years?
The market is expected to remain above $800 million annually, supported by consistent allergy prevalence.
4. Are there upcoming regulatory changes that could influence this drug?
FDA approvals of new allergy treatments or biosimilars could shift market share but have not yet been announced.
5. How does OTC availability affect the drug’s pricing and sales?
OTC sales increase volume, while OTC pricing is more competitive, leading to lower retail prices compared to prescription channels.
References
- IQVIA, 2022. US Over-the-Counter and Prescription Drug Sales Data.
- FDA National Drug Code Directory, 2023.
- MarketWatch, "Allergy Drug Market Analysis," 2022.
- Sanofi, "Allegra Product Summary," 2011.
- Statista, "Pharmaceutical Pricing Trends," 2023.
