Understanding the NDC System
The National Drug Code (NDC) is a unique, three-segment number that identifies drug products in the United States. For the drug with the NDC 62135-0010, the first segment (62135) is the labeler code assigned by the FDA, the second segment identifies the product (in this case, Hydroxyzine Hydrochloride), and the third segment identifies the package size and type[1].
Drug Overview: Hydroxyzine Hydrochloride
Hydroxyzine Hydrochloride, identified by the NDC 62135-0010, is a prescription drug used for the symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states where anxiety is manifested[5].
Market Trends in Prescription Drugs
The prescription drug market is influenced by several key trends:
Pricing and Access
Pricing and access to drugs are significant issues facing the life sciences industry. C-suite executives identify these as major concerns, with nearly half expecting these factors to significantly impact their strategies in 2025[3].
Global Price Comparisons
The average price per unit of prescription drugs in the U.S. is notably higher than in other regions. In 2022, U.S. prices were 5.5 times higher than in the OECD (excluding the U.S.) and 7.7 times higher than in the rest of the world. This disparity is partly due to a drug mix that skews towards more expensive compounds in the U.S.[4].
Generic and Biosimilar Competition
Competition from generic drugs and biosimilars is a top trend, with 37% of respondents viewing this as a significant concern. The biopharma industry faces substantial losses due to expiring patents, which could drive interest in mergers and acquisitions[3].
Price Transparency and Regulatory Oversight
Oregon's Drug Price Transparency Program
Oregon's program requires manufacturers to report price increases and new high-cost drugs. The program has highlighted significant price increases, such as a 2,527% increase for a generic naproxen, and variable quality of information submitted by manufacturers. Regulatory efforts aim to improve transparency across the pharmaceutical supply chain[2].
Compliance and Enforcement
Manufacturers not complying with reporting requirements face noncompliance notices and potential enforcement actions. This oversight is crucial for understanding and addressing the impact of costly prescription drugs on consumers[2].
Price Projections for Hydroxyzine Hydrochloride
Given the broader market trends:
Impact of Generic Competition
As a generic drug, Hydroxyzine Hydrochloride is likely to face competition from other generic versions. This competition can lead to price reductions over time. For example, the median price increase for generic drugs was 19.9% in 2022, but significant price drops can occur as more generics enter the market[2].
Regulatory and Transparency Efforts
Increased transparency and regulatory oversight can lead to more stable or reduced prices. However, the effectiveness of these measures in controlling prices is still being evaluated, and gaps in transparency remain a challenge[2].
Global Pricing Dynamics
While U.S. prices are generally higher, international pricing dynamics can influence domestic prices. The significant price disparities between the U.S. and other regions may lead to policy changes or market adjustments that could impact the price of Hydroxyzine Hydrochloride[4].
Key Factors Influencing Price
- Competition from Generics and Biosimilars: Increased competition can drive prices down.
- Regulatory Oversight: Transparency programs and compliance measures can influence pricing.
- Global Market Trends: Higher prices in the U.S. compared to other regions may lead to policy changes.
- Patent Expirations: Loss of exclusivity can lead to increased generic competition and lower prices[3].
Predictive Analysis
Given these factors, here are some potential price projection scenarios for Hydroxyzine Hydrochloride:
Scenario 1: Competitive Market
With increased generic competition and regulatory pressure for transparency, prices for Hydroxyzine Hydrochloride could decrease by 10-20% over the next few years.
Scenario 2: Stable Market
If the current market dynamics remain unchanged, prices might stabilize with minimal increases or decreases, reflecting the balance between competition and regulatory oversight.
Scenario 3: Regulatory Impact
If regulatory efforts to control prices and improve transparency are successful, prices could decrease more significantly, potentially by 30-40% as the market adjusts to new policies.
"Understanding how these entities and cost factors influence the supply chain and ultimately the costs consumers face is necessary to developing policy recommendations to address these issues."[2]
Conclusion
The price projections for Hydroxyzine Hydrochloride (NDC: 62135-0010) are influenced by a complex interplay of market trends, regulatory oversight, and global pricing dynamics. While precise predictions are challenging, the general direction suggests that prices could stabilize or decrease due to increased competition and regulatory efforts.
Key Takeaways
- Market Trends: Pricing and access issues, generic competition, and global price disparities are key factors.
- Regulatory Oversight: Transparency programs and compliance measures are crucial for controlling prices.
- Price Projections: Potential scenarios include price decreases due to competition and regulatory pressure.
- Global Dynamics: U.S. prices are higher than in other regions, which could lead to policy changes.
FAQs
What is the NDC system, and how does it identify drugs?
The National Drug Code (NDC) system uses a unique, three-segment number to identify drug products. The segments include the labeler code, product code, and package code[1].
Why are U.S. prescription drug prices higher than in other regions?
U.S. prices are higher due to a combination of higher prices for the same drugs and a drug mix that skews towards more expensive compounds[4].
How does generic competition affect drug prices?
Generic competition can significantly reduce prices as more generic versions of a drug enter the market, increasing competition and driving prices down[2].
What role does regulatory oversight play in drug pricing?
Regulatory oversight, such as transparency programs, helps in controlling prices by requiring manufacturers to report price increases and ensuring compliance with reporting requirements[2].
How might global pricing dynamics influence domestic prices?
Global pricing dynamics can influence domestic prices through policy changes or market adjustments aimed at reducing the significant price disparities between the U.S. and other regions[4].
Sources
- FDA: National Drug Code Database Background Information.
- Oregon Department of Consumer and Business Services: Prescription Drug Price Transparency Annual Report 2022.
- Deloitte Insights: 2025 Life Sciences Executive Outlook.
- ASPE: International Market Size and Prices.
- DailyMed: HYDROXYZINE HYDROCHLORIDE syrup.
