Introduction
The drug identified by the National Drug Code (NDC) 50458-0575 is XARELTO (rivaroxaban) oral suspension, a product manufactured by Janssen Pharmaceuticals. This article will delve into the market analysis and price projections for this specific drug, considering various factors such as regulatory environments, market trends, and economic projections.
Understanding the Drug: XARELTO (Rivaroxaban)
XARELTO is an anticoagulant used to prevent and treat blood clots. The NDC 50458-0575 specifically refers to the oral suspension formulation, which is supplied as white to off-white granules in an amber glass bottle, packaged with oral dosing syringes[4].
Market Size and Growth
The anticoagulant market, which includes drugs like XARELTO, is part of the broader pharmaceutical market. The biopharma and biotech industries, which encompass anticoagulants, are experiencing significant growth. As of 2024, the biopharma market size was estimated to be over $400 billion, with a projected compound annual growth rate (CAGR) of 7.56% between 2024 and 2029[3].
Regulatory Environment
The regulatory landscape plays a crucial role in drug pricing and market dynamics. The FDA's National Drug Code Directory, which includes information on all drugs manufactured, prepared, propagated, compounded, or processed for sale in the U.S., is a key resource. For XARELTO, the NDC Directory ensures compliance with FDA regulations, including the requirement for labelers to submit product listing data in structured product labeling (SPL) electronic listing files[1].
Price Projections
Current Pricing
The current pricing of XARELTO oral suspension is not explicitly stated in the provided sources, but it can be inferred from the broader market trends and pricing strategies of similar anticoagulants.
Future Price Trends
Several factors will influence the future pricing of XARELTO:
- Drug Price Inflation: Vizient projects an overall drug price inflation rate of 3.81% for 2025, which could impact the pricing of XARELTO[2].
- Negotiated Prices: Although XARELTO is not listed among the drugs selected for the Medicare Drug Price Negotiation Program for 2026, similar negotiations could set precedents that affect future pricing strategies. For example, the negotiated prices for other drugs under this program have resulted in significant savings, indicating potential downward pressure on prices[5].
Impact of Regulatory Changes
The Medicare Drug Price Negotiation Program, part of the Inflation Reduction Act, aims to reduce drug costs for Medicare beneficiaries. While XARELTO is not currently part of this program, any future inclusion or similar regulatory changes could significantly impact its pricing. The program's negotiated prices are adjusted annually based on the Consumer Price Index (CPI-U), ensuring that prices do not escalate excessively[5].
Market Competition
The anticoagulant market is competitive, with several other drugs available. The pricing of XARELTO will need to be competitive to maintain market share. Innovations in clinical trial designs and the rise of precision medicine, as predicted for the biopharma and biotech industries, could also influence pricing strategies as companies balance innovation costs with market demand[3].
Economic Projections
Given the projected drug price inflation rate of 3.81% for 2025, it is likely that the price of XARELTO oral suspension will increase, albeit moderately. Here is a hypothetical projection:
- Current Price: Assume the current price for a 30-day supply of XARELTO oral suspension is around $500 (for illustrative purposes).
- Projected Price for 2025: With a 3.81% inflation rate, the price could increase to approximately $519 for a 30-day supply.
- Long-term Projections: Over the next few years, if the inflation rate stabilizes or decreases, the price increase might be more modest. However, any inclusion in future negotiation programs or significant regulatory changes could alter this projection.
Key Takeaways
- Market Growth: The biopharma and biotech industries are growing rapidly, with a CAGR of 7.56% projected between 2024 and 2029.
- Regulatory Impact: FDA regulations and programs like the Medicare Drug Price Negotiation Program can significantly influence drug pricing.
- Price Projections: A moderate increase in the price of XARELTO oral suspension is expected due to drug price inflation, but regulatory changes could impact this projection.
- Market Competition: The competitive nature of the anticoagulant market will continue to influence pricing strategies.
FAQs
What is the NDC code for XARELTO oral suspension?
The NDC code for XARELTO oral suspension is 50458-0575[4].
How is the price of XARELTO oral suspension expected to change in 2025?
The price is expected to increase moderately, around 3.81%, due to projected drug price inflation[2].
What regulatory programs could impact the pricing of XARELTO?
Programs like the Medicare Drug Price Negotiation Program, although not currently including XARELTO, could set precedents that affect future pricing strategies[5].
How does the competitive market influence the pricing of XARELTO?
The competitive anticoagulant market forces manufacturers to maintain competitive pricing to retain market share[3].
What are the storage requirements for XARELTO oral suspension?
XARELTO oral suspension should be stored at room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F). It should not be frozen[4].
Sources
- FDA's National Drug Code Directory - FDA
- Vizient projects drug price inflation at 3.81% - Vizient, Inc.
- 5 Predictions for the Biopharma and Biotech Industries in 2025 - TFS CRO
- XARELTO - How Supplied - Janssen Science
- Medicare Drug Price Negotiation Program - CMS
