Introduction
Nitroglycerin Lingual Spray, with the NDC code 28595-120, is a prescription drug used for the acute relief of angina pectoris. Here, we will delve into the market analysis and price projections for this medication, considering various factors such as market trends, regulatory changes, and industry predictions.
Market Context
The pharmaceutical market, particularly for cardiovascular medications like nitroglycerin, is influenced by several key factors:
Spending Trends
Medicine spending in the U.S. has seen a mix of growth and decline in recent years. According to IQVIA, net spending on medicines grew by 0.6% in 2017, but when adjusted for discounts and rebates, it declined by 2.2% on a per capita basis[4].
Regulatory Environment
The regulatory landscape is crucial for drug pricing. The Medicare Drug Price Negotiation Program, for instance, is set to impact drug prices significantly starting in 2026. This program will negotiate prices for certain drugs, including those under Medicare, which could lead to price reductions and savings for patients[2].
Product Overview
Nitroglycerin Lingual Spray is marketed by Allegis Pharmaceuticals, LLC, and was approved under the New Drug Application (NDA) process. Here are some key details:
Dosage and Administration
The spray contains 400 micrograms of nitroglycerin per dose and is administered orally for the rapid relief of angina symptoms[1][5].
Contraindications and Precautions
The drug is contraindicated in patients using selective inhibitors of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) inhibitors. It also requires careful dose selection in elderly patients due to potential decreased hepatic, renal, or cardiac function[5].
Market Analysis
Current Market
The market for nitroglycerin products is established, with various formulations available. The introduction of the lingual spray in 2019 expanded the options for patients, offering a convenient and rapid-acting form of nitroglycerin[1].
Competitive Landscape
The cardiovascular drug market is highly competitive, with multiple brands and generics available. The pricing strategy for Nitroglycerin Lingual Spray must consider the competition from other nitroglycerin formulations and other angina treatments.
Price Projections
Impact of Medicare Drug Price Negotiation Program
Starting in 2026, the Medicare Drug Price Negotiation Program could significantly impact the pricing of drugs, including those used for cardiovascular conditions. If Nitroglycerin Lingual Spray is selected for negotiation, its price could be reduced, aligning with the program's goal of lowering drug costs for Medicare beneficiaries[2].
General Pricing Trends
Historically, pharmacy prices for brand prescriptions have increased, but out-of-pocket costs for patients have declined due to discounts and rebates. This trend may continue, but the introduction of negotiated prices under the Medicare program could stabilize or reduce prices[4].
Industry Predictions and Trends
Use of AI and Data Analytics
The pharmaceutical industry is increasingly adopting AI and data analytics to optimize operations and decision-making. This trend could influence pricing strategies by providing more accurate market analysis and demand forecasting[3].
Shift to Specialty Medicines
There has been a significant shift towards specialty medicines, which often come with higher price tags. However, the balance between innovation and affordability will continue to be a key consideration in the pricing of drugs like Nitroglycerin Lingual Spray[4].
Economic and Regulatory Factors
Inflation and CPI Adjustments
Negotiated prices under the Medicare program will be adjusted annually based on the Consumer Price Index (CPI). This ensures that prices keep pace with inflation, which could impact the long-term pricing strategy for Nitroglycerin Lingual Spray[2].
Regulatory Changes
Changes in regulatory processes, such as breakthrough designations and patient-reported outcomes, can influence the approval and pricing of new drugs. These factors can also affect the pricing of existing drugs by setting new benchmarks for efficacy and safety[4].
Key Takeaways
- Market Trends: The pharmaceutical market is characterized by growth in specialty medicines and declining out-of-pocket costs due to discounts and rebates.
- Regulatory Impact: The Medicare Drug Price Negotiation Program will likely reduce prices for selected drugs, including potentially Nitroglycerin Lingual Spray.
- AI and Data Analytics: Increased use of AI and data analytics will enhance market analysis and pricing strategies.
- Economic Adjustments: Prices will be adjusted annually based on CPI to account for inflation.
FAQs
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What is the current dosage and administration of Nitroglycerin Lingual Spray?
- Nitroglycerin Lingual Spray contains 400 micrograms of nitroglycerin per dose and is administered orally for the rapid relief of angina symptoms[1][5].
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How might the Medicare Drug Price Negotiation Program affect the price of Nitroglycerin Lingual Spray?
- If selected, the program could significantly reduce the price of Nitroglycerin Lingual Spray, aligning with the program's goal of lowering drug costs for Medicare beneficiaries[2].
-
What are the contraindications for Nitroglycerin Lingual Spray?
- The drug is contraindicated in patients using selective inhibitors of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) inhibitors[5].
-
How is the pricing of Nitroglycerin Lingual Spray expected to change over time?
- Prices may be stabilized or reduced due to the Medicare Drug Price Negotiation Program and will be adjusted annually based on the Consumer Price Index (CPI)[2].
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What role does AI and data analytics play in the pricing strategy of pharmaceuticals like Nitroglycerin Lingual Spray?
- AI and data analytics are increasingly used to optimize operations and decision-making, providing more accurate market analysis and demand forecasting[3].
Sources
- FDA Report: NDC 28595-120 Oral Spray NITROGLYCERIN LINGUAL Drug Information.
- CMS Fact Sheet: Medicare Drug Price Negotiation Program - CMS.
- Intelligencia AI Blog: 2025 Pharma Predictions: AI, Health Tech, and Data Trends to Watch.
- IQVIA Report: Medicine Use and Spending in the U.S. A Review of 2017 Outlook to 2022.
- DailyMed Label: NITROGLYCERIN LINGUAL- nitroglycerin spray.
