Introduction
The National Drug Code (NDC) 59651-0136 corresponds to a product manufactured by Aurobindo Pharma Limited. To conduct a comprehensive market analysis and price projection for this specific drug, we need to consider several factors, including the drug's category, market trends, regulatory environment, and pricing dynamics.
Drug Identification
The NDC 59651-0136 is associated with Emtricitabine and Tenofovir Disoproxil Fumarate, a combination antiretroviral therapy used in the treatment of HIV-1 infection. This drug is listed under the labeler/manufacturer Aurobindo Pharma Limited[4].
Market Trends in Prescription Drugs
Global and U.S. Market
The prescription drug market has seen significant growth over the past few years, driven by increasing demand and high prices, particularly in the U.S. Compared to other OECD countries, the U.S. has notably higher average prices per unit for prescription drugs. By 2022, prices in the U.S. were 5.5 times those in the OECD (excluding the U.S.) and 7.7 times prices in the rest of the world (excluding the U.S.)[3].
Volume and Revenue Growth
Between 2017 and 2022, the U.S. prescription drug market experienced an 8% growth in volume, which is lower than the 13% growth seen in the rest of the world. However, the sales revenue growth in the U.S. was significantly higher, driven by increasing prices rather than volume[3].
Pricing Dynamics
List Price Increases
Many prescription drugs, including those used in chronic conditions like HIV, have seen substantial list price increases over recent years. For example, between 2018 and 2023, nine out of ten drugs selected for Medicare Part D negotiations saw list price increases ranging from 20% to 55%[2].
Negotiated Prices
The Medicare Drug Price Negotiation Program, set to begin in 2026, aims to reduce prescription drug costs for Medicare enrollees. Negotiations have resulted in discounts ranging from 38% to 79% compared to list prices for the selected drugs. While this specific drug (NDC 59651-0136) is not listed among the initial ten drugs for negotiation, such programs indicate a broader trend towards price regulation and potential future discounts[2][5].
Regulatory Environment
FDA Regulations
The FDA's National Drug Code Directory includes information on all finished and unfinished drugs, including those manufactured by Aurobindo Pharma Limited. Drug establishments are required to provide the FDA with a current list of all drugs manufactured, prepared, propagated, compounded, or processed in commercial distribution in the U.S.[1].
Compounded Drug Products
Outsourcing facilities, which may produce compounded versions of drugs like Emtricitabine and Tenofovir Disoproxil Fumarate, are regulated under Section 503B of the FD&C Act. These facilities may assign NDCs to their products but are not required to do so. They must report their compounded drugs to the FDA on a regular basis[1].
Price Projections
Current Pricing
As of the latest data, the pricing for Emtricitabine and Tenofovir Disoproxil Fumarate (NDC 59651-0136) would be influenced by the current market dynamics, including the high prices characteristic of the U.S. market.
Future Pricing Trends
Given the trends in list price increases and the impact of negotiated prices under programs like Medicare Part D, it is likely that prices for this drug could see some stabilization or reduction in the future. Here are a few possible scenarios:
Scenario 1: Continued List Price Increases
If the historical trend of list price increases continues, the price of NDC 59651-0136 could rise by 10-20% over the next few years, aligning with the average increases seen in similar drugs.
Scenario 2: Impact of Negotiated Prices
If the drug becomes subject to negotiated prices under programs like Medicare Part D or other price regulation initiatives, the price could decrease significantly, potentially by 30-50% or more, as seen in the initial negotiations for other drugs.
Scenario 3: Market Competition
Increased competition from generic or biosimilar versions of the drug could also drive prices down. Aurobindo Pharma Limited, being a generic manufacturer, might already be offering this drug at a lower price compared to the brand-name version.
Key Takeaways
- Market Trends: The U.S. prescription drug market is characterized by high prices and significant revenue growth driven by price increases rather than volume.
- Regulatory Environment: FDA regulations and programs like Medicare Part D negotiations can significantly impact drug pricing.
- Price Projections: Future prices for NDC 59651-0136 could be influenced by continued list price increases, negotiated price reductions, or market competition.
FAQs
What is the NDC 59651-0136 used for?
NDC 59651-0136 corresponds to Emtricitabine and Tenofovir Disoproxil Fumarate, a combination antiretroviral therapy used in the treatment of HIV-1 infection.
How are prescription drug prices regulated in the U.S.?
Prescription drug prices are regulated through various mechanisms, including FDA oversight, Medicare Part D negotiations, and other price regulation initiatives.
What is the impact of Medicare Part D negotiations on drug prices?
Medicare Part D negotiations have resulted in significant discounts, ranging from 38% to 79% compared to list prices, for the selected drugs.
How does the FDA track and regulate compounded drug products?
The FDA requires outsourcing facilities to report their compounded drugs on a regular basis and may assign NDCs to these products, although it is not mandatory[1].
What are the potential future pricing trends for NDC 59651-0136?
Future pricing trends could include continued list price increases, negotiated price reductions, or decreases due to market competition from generic or biosimilar versions.
Sources
- FDA: National Drug Code Directory - FDA
- ASPE: Medicare Drug Price Negotiation Program - ASPE - HHS.gov
- ASPE: ISSUE BRIEF - ASPE
- FindACode: Aurobindo Pharma Limited - List of Drugs - NDC Labeler/Manufacturer
- CMS: Medicare Drug Price Negotiation Program - CMS
