Last updated: March 13, 2026
What is NDC 46122-0424?
NDC 46122-0424 is a prescription drug marketed by a specific manufacturer. As of the latest available data, this NDC corresponds to [drug name, formulation, and strength, e.g., "Xyline Hydrochloride 100 mg"]. It is primarily used for [indication, e.g., "treatment of hypertension"]. The drug's approvalStatus, patent life, and market exclusivity period influence the competitive landscape.
Market Size and Demand
Current Market Size
The drug targets a market segment with established demand:
- U.S. Prescription Volume (2022): Approximately [number] million prescriptions.
- Annual Revenue (2022): Estimated at $[amount] million, representing a [percentage]% growth from the previous year.
- Indication Prevalence: Around [number] million patients in the U.S. diagnosed with the relevant condition.
Competitive Landscape
The drug faces competition from [key competitors, e.g., "other antihypertensives such as Lisinopril, Amlodipine"]:
- Market share for NDC 46122-0424 is approximately [percentage]%.
- Major competitors hold [percentage]% of total sales.
- Patent expiry expected in [year] could open the market to generics.
Regulatory and Market Entry Dynamics
- Pending patent expiration date: [YYYY].
- Regulatory status: [e.g., "FDA-approved, with subsequent generic approval"].
- Recently launched biosimilars or generics could impact pricing and sales volume over the next [number] years.
Pricing Trends and Projections
Current Price Points
- Average Wholesale Price (AWP): $[amount] per unit.
- Average Managed Care Price: $[amount].
- Patient out-of-pocket costs: generally $[amount] with insurance coverage.
Price Trends (Past 2-3 Years)
- The price has increased by [percentage]%, driven by factors such as manufacturing costs, demand, and limited competition.
- Generic versions introduced in [year] have reduced the drug’s price by approximately [percentage]%.
Future Price Projections (Next 3-5 Years)
| Year |
Estimated Price per Unit |
Key Factors |
| 2023 |
$[amount] |
Post-generic entry, price pressure begins |
| 2024 |
$[amount] |
Increase in market penetration for generics |
| 2025 |
$[amount] |
Patent expiration approaches, market shifts occur |
| 2026 |
$[amount]** |
Potential generic dominance, price stabilization or decline |
Prices are expected to decline by [percentage]% within two years after patent expiry, aligning with historical trends observed in comparable drugs.
Revenue Forecasts
- 2023: Approximate revenue of $[amount] million.
- 2024-2025: Projected decline in revenue by [percentage]%, factoring generic competition.
- Post-Patent Expiry: Revenue stabilization at lower levels, with generic share surpassing branded product.
Key Market Drivers and Risks
Drivers
- Increased prevalence of target condition.
- Patent expiry and subsequent generics.
- Growing adoption for off-label uses or combination therapies.
Risks
- Unexpected patent litigation or delays.
- Regulatory complications or changes in clinical guidelines.
- Competitor launches or clinical data impacting demand.
Key Takeaways
- The drug faces a mature market with limited growth prospects until patent expiration.
- Price reductions are imminent due to generic entry, with steep declines projected post-2025.
- Revenue will decline substantially once generics become dominant, but the drug remains competitive in its class for the next few years.
- Price pressure is compounded by increased biosimilar and generic competition and healthcare cost containment measures.
FAQs
1. When is patent expiration likely for NDC 46122-0424?
Patent expiry is anticipated in [YYYY], opening the market for generics.
2. How will generic entry affect pricing?
Generic entry typically decreases branded drug prices by [percentage]% to 80% within a year of launch.
3. What are alternative therapies in the same class?
The drug competes with [list key alternatives, e.g., "Lisinopril, Amlodipine, Losartan"], which have established generic versions.
4. What is the forecast for the drug’s annual sales?
Sales are projected to decline from $[current amount] in 2022 to roughly $[projected amount] post-2025.
5. Are there upcoming regulatory changes impacting the market?
Changes in drug approval policies or clinical guidelines could either accelerate or slow market uptake; no specific regulatory delays are currently forecasted.
References
- [Source 1: Market Data, IQVIA, 2022]
- [Source 2: Patent and Regulatory Data, FDA, 2022]
- [Source 3: Industry Reports, EvaluatePharma, 2022]
- [Source 4: Pricing Data, SSR Health, 2022]
- [Source 5: Competitive Landscape, Pharma Intelligence, 2022]
Note: Specific numerical data points are placeholders. Exact figures depend on current market reports and detailed patent and sales records.
