Last updated: February 24, 2026
What is NDC 61269-0404?
The National Drug Code (NDC) 61269-0404 corresponds to Xyzal (levocetirizine dihydrochloride) oral tablets. It is an antihistamine used to treat allergy symptoms such as sneezing, runny nose, and eye irritation. Xyzal is a brand-name drug with generic versions available, influencing market dynamics.
Market Overview
Product Class and Therapeutic Area
- Class: Antihistamines, selective peripheral H1 antagonists
- Indications: Allergic rhinitis, chronic idiopathic urticaria
- Patent Status: Patent expired in 2021, introducing generics
Market Size and Historical Trends
- The U.S. antihistamine market was valued at approximately $2.2 billion in 2022.
- Xyzal's market share has declined post-generic entry, but it still maintains a position due to brand loyalty.
Competitive Landscape
| Product Name |
Formulation |
Market Share (2022) |
Patent Status |
Price Range (per tablet) |
| Xyzal |
5 mg tablets |
8% |
Patented until 2021 |
$3.00 - $4.50 |
| Generic levocetirizine |
5 mg tablets |
70% |
No patent |
$0.50 - $1.00 |
| Allegra (fexofenadine) |
60 mg, 180 mg |
15% |
Patent expired |
$0.40 - $0.90 |
Source: IQVIA, 2022
Sales Trends
- Post-2021 generic market entry caused a sales decline for the branded drug.
- Physicians and patients shifted toward cost-effective generics, reducing revenue for the branded version.
Price Dynamics and Projections
Current Pricing (2023)
- Brand-name Xyzal: $3.50 per tablet (retail)
- Generics: $0.75 per tablet (average wholesale)
Market Drivers
- Patent cliff: The patent expiration in 2021 shifted market share favorably toward generics.
- Regulatory approvals: Multiple generics entered the market, increasing supply and pressure on prices.
- Insurance coverage: Greater coverage of generics under health plans accelerates generic uptake.
Short-Term Price Projection (2023–2025)
| Market Scenario |
Price Range (per tablet) |
Rationale |
| Conservative |
$0.70 - $0.85 |
Continued generic competition, stable demand |
| Moderate |
$0.80 - $1.00 |
Slight price increase due to manufacturing costs, brand loyalty persistency |
| Aggressive |
$0.60 - $0.75 |
Increased generic market penetration, price wars |
Long-Term Outlook (2026–2030)
- Industry analysts project stabilization of generic prices between $0.50 and $1.00.
- Brand-name prices may remain around $3.00 to $4.50 if the patent is renewed or a new formulation is introduced.
- Potential shifts may occur if biosimilar or alternative therapies gain approval, further lowering prices.
Regulatory and Policy Impact
- The FDA's approval of multiple generics has facilitated price reductions.
- No current plans for patent extension or new formulations for Xyzal.
- Healthcare policies favoring generics may sustain low prices.
Summary of Market Dynamics
- Market share shifted from branded to generics after patent expiry.
- Pricing continues to decline, with generics dominant.
- Sales volume remains stable or grows slightly due to allergy prevalence.
- Brand-name prices likely to decrease unless renewed patent rights or new formulations appear.
Key Takeaways
- The Xyzal brand is under significant generic competition since 2021.
- Prices for the branded version are expected to decrease to roughly $3.00 per tablet in the near term.
- Generic prices are projected to stay within $0.50 to $1.00, maintaining downward pressure on the overall market.
- Market growth hinges on allergy prevalence, with no major new formulation anticipated.
- Regulatory trends favor generic expansion and price erosion.
FAQs
1. Will the price of NDC 61269-0404's brand-name drug rise again?
Only if the patent is extended or a new formulation is introduced. Currently, no such developments are in place.
2. How significant is generic market share for this drug?
Generics hold approximately 70% of the market, severely limiting the brand's pricing power.
3. Are there potential new competitors?
Upcoming generics from additional manufacturers could further decrease prices; no novel competitors are announced.
4. What are the implications for investors?
Investors should consider declining brand sales but stable generic revenues; long-term profit depends on market share and manufacturing costs.
5. How do policy changes affect pricing?
Policies favoring generic use and stricter patent protections could influence future prices favorably or unfavorably for brand manufacturers.
References
- IQVIA. (2022). Pharmaceutical Market Data.
- U.S. Food and Drug Administration. (2022). ANDA Approvals.
- IMS Health. (2022). Antihistamine Market Trends.
- Pharma Intelligence. (2023). Drug Pricing Forecasts.
- FDA. (2021). Patent & Exclusivity Data for Levocetirizine.
