Overview of Daliresp
Daliresp, with the NDC code 0310-0095, is a human prescription drug product labeled by AstraZeneca Pharmaceuticals LP. The generic name of Daliresp is roflumilast, which is primarily used for the treatment of chronic obstructive pulmonary disease (COPD) to reduce the risk of COPD exacerbations[1].
Market Context
The pharmaceutical market, particularly for respiratory drugs like Daliresp, is influenced by several factors including regulatory requirements, competition from generic versions, and pricing transparency.
Regulatory Environment
The FDA's National Drug Code (NDC) Directory plays a crucial role in tracking and regulating drug products, including Daliresp. Drug establishments must provide the FDA with a current list of all drugs manufactured, prepared, propagated, compounded, or processed for sale in the U.S.[4].
Competition and Generics
Daliresp faces competition from generic versions of roflumilast. Several pharmaceutical companies, such as Camber Pharmaceuticals, Micro Labs USA, Novadoz Pharmaceuticals, and Zydus Pharmaceuticals, offer generic alternatives. This competition can impact the pricing strategy for the brand name drug[5].
Pricing Dynamics
Current Pricing
As of the latest data, the price per unit for Daliresp (NDC 0310-0095) is approximately $13.77 per tablet, with package options of 30 and 90 tablets[1].
Price Transparency and Regulatory Oversight
The Oregon Drug Price Transparency Program highlights the importance of transparency in drug pricing. The program requires manufacturers to report price increases and new high-cost drugs. However, the variability in the quality of information submitted by manufacturers remains a challenge. The median price increase for generic drugs was 19.9% in 2022, while for brand name drugs it was 13.4%[2].
Impact of Generic Competition
The presence of generic versions significantly affects the pricing of brand name drugs. Generic drugs often offer a more affordable alternative, which can lead to a reduction in the market share and pricing power of the brand name drug. For example, the generic versions of roflumilast are priced significantly lower than Daliresp, ranging from $0.36 to $13.62 per tablet depending on the manufacturer[5].
Price Projections
Market Trends
The pharmaceutical market is subject to various trends and regulatory changes. The Inflation Reduction Act of 2022, for instance, introduced price negotiation authority for Medicare, which could influence pricing strategies across the industry. States like Oregon are also implementing drug affordability boards to review and potentially set upper payment limits for high-cost drugs[2].
Generic Market Impact
Given the increasing competition from generics, it is likely that the price of Daliresp will face downward pressure. As more generic versions enter the market, AstraZeneca may need to adjust its pricing strategy to remain competitive.
Regulatory and Policy Changes
Future policy changes, such as the implementation of upper payment limits or enhanced price transparency measures, could further impact the pricing of Daliresp. These measures aim to make drugs more affordable but could also reduce the revenue generated by brand name drugs[2].
Key Takeaways
- Regulatory Environment: The FDA's NDC Directory and state-level transparency programs play crucial roles in regulating and monitoring drug prices.
- Competition: Generic versions of roflumilast significantly impact the pricing and market share of Daliresp.
- Pricing Dynamics: Current prices are around $13.77 per tablet, but this could decrease due to generic competition and regulatory changes.
- Future Projections: The price of Daliresp is likely to face downward pressure due to market trends and regulatory oversight.
FAQs
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What is the generic name of Daliresp?
- The generic name of Daliresp is roflumilast[1].
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What is the current price per unit of Daliresp (NDC 0310-0095)?
- The current price per unit is approximately $13.77 per tablet[1].
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How does generic competition affect the pricing of Daliresp?
- Generic competition significantly reduces the pricing power of Daliresp, as generic versions are often much cheaper[5].
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What regulatory measures are in place to monitor drug prices?
- The FDA's NDC Directory and state-level drug price transparency programs monitor and regulate drug prices[2][4].
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What are the potential future price projections for Daliresp?
- The price is likely to decrease due to increased generic competition and potential regulatory changes aimed at enhancing price transparency and affordability[2][5].
Sources
- NDC 0310-0095 Daliresp Tablet Oral - NDC List.
- Prescription Drug Price Transparency Results and Recommendations - Oregon Department of Consumer and Business Services.
- Global Dry Eye Syndrome Drug Forecast and Market Analysis to 2028 - Business Wire.
- National Drug Code Directory - FDA - FDA.
- Information for Vermont Prescribers of Prescription Drugs - AstraZeneca US.