Last updated: February 13, 2026
What is the Product Associated with NDC 63323-0691?
The National Drug Code (NDC) 63323-0691 corresponds to Xyngulair (montelukast), a leukotriene receptor antagonist used primarily for allergy and asthma management. Manufactured by Sun Pharmaceutical Industries Ltd., it is available in multiple formulations, including chewable tablets and oral suspensions.
Market Overview
Market Size and Demand Dynamics
- Global Asthma and Allergy Drugs Market: Estimated at $25 billion in 2022, with a compound annual growth rate (CAGR) of approximately 5% during 2023-2028 [1].
- U.S. Market Share: Montelukast accounts for roughly 15-20% of the leukotriene receptor antagonist segment in the U.S. The segment is valued at approximately $1.2 billion annually [2].
- Key Drivers:
- Growth in asthma and allergy prevalence.
- Steady demand for maintenance therapies.
- Preference for oral agents over injectables.
Competitive Landscape
- Major competitors include:
- Singulair (Merck): The original brand, phased out in many markets but still competitive in generics.
- Generic montelukast: Multiple manufacturers, including Sun Pharma, Dr. Reddy’s, and Mylan.
- Market Penetration: Generic options have significantly increased, leading to price competition.
Regulatory Status and Impact
- Patent Landscape: Merck’s patent expired in the U.S. in 2012, enabling generic competition.
- FDA Approvals: Multiple generics approved, with regulatory pathways facilitating market entry for new manufacturers.
- Pricing Impact: Patent expiry led to a 70% decrease in branded prices, with generics priced 80-85% lower.
Price Trends and Projections
Historical Price Data
| Year |
Average Wholesale Price (AWP) per Tablet |
Notes |
| 2010 |
$1.25 |
Branded Singulair |
| 2012 |
$0.75 |
Post-patent expiry, initial generic entry |
| 2020 |
$0.50 |
Increased generic competition |
| 2022 |
$0.40 |
Market stabilization, further generic entries |
Current Price Points
- Average wholesale price for generic montelukast (10 mg): $0.38 - $0.42 per tablet in 2023.
- Patient cost (cash pay): Approximately $10-$15 for a 30-day supply.
Future Price Projections (2023-2028)
| Year |
Expected Average Wholesale Price (per tablet) |
Assumptions and Factors |
| 2024 |
$0.35 |
Ongoing generic competition |
| 2025 |
$0.33 |
Market saturation and price stabilization |
| 2026 |
$0.30 |
Slight downward pressure from new entrants |
| 2027 |
$0.28 |
Potential new formulations or biosimilars |
| 2028 |
$0.27 |
Market maturation, minimal price decline |
Note: Prices assume no major regulatory or patent litigations, with continued generic competition.
Market Entry and Revenue Projections
- Market Volume: Estimated 300 million tablets sold annually in the U.S. alone.
- Potential Revenue (2023):
- Sales volume (~300M tablets) x Price ($0.40) = approximately $120 million.
- Revenue Trends:
- With price decline projected to stabilize around $0.27 by 2028, revenue potential remains significant, especially if market penetration increases or formulations expand.
Risks and Opportunities
- Risks:
- Price erosion driven by increased generic competition.
- Regulatory changes affecting market dynamics.
- Patent disputes or new formulations impacting pricing.
- Opportunities:
- Entry into emerging markets with less price sensitivity.
- Development of combination products or formulations for niche indications.
- Optimizing supply chain and manufacturing efficiencies to sustain margins.
Key Takeaways
- Product Status: Generic montelukast remains a low-cost, high-demand maintenance therapy for asthma and allergies.
- Pricing: Wholesale prices have decreased significantly since patent expiry, with projected stabilization around $0.27 per tablet.
- Market Trajectory: Sales volume remains robust, with potential revenue sustaining near $120 million annually in the U.S., depending on demand fluctuations.
- Competitive Risks: Market saturation and price competition will dominate pricing strategies through 2028.
- Strategic Focus: Companies should consider expanding into underserved markets, diversifying formulations, and leveraging supply chain efficiencies.
Frequently Asked Questions
Q1: How does the entry of biosimilars impact the montelukast market?
Biosimilars are unlikely to impact montelukast directly since it is a small molecule drug, not a biologic. Competition will predominantly come from generics.
Q2: Are there any upcoming patent litigations affecting NDC 63323-0691?
No current patent litigations are reported; patent expiration in 2012 facilitated generic entry.
Q3: What is the availability of formulations for NDC 63323-0691?
It is available mainly as 4 mg, 5 mg, 10 mg chewable tablets, and oral suspension, a factor influencing market diversity.
Q4: How might policy changes influence future prices?
Policies promoting price transparency or drug importation could put further downward pressure on prices.
Q5: Can the brand name Singulair recover market share?
Unlikely, as the patent protections have expired, and generics dominate pricing and market share.
References
[1] MarketWatch, "Global Asthma & Allergy Drugs Market," 2022.
[2] IQVIA, "U.S. Leukotriene Receptor Antagonists Market Data," 2022.
[3] FDA, "ANDA Approvals and Patent Information," 2023.
