Overview of Nitroglycerin Injection
Nitroglycerin injection, with the NDC code 00517-4810-25, is a critical medication used primarily for the treatment of acute myocardial infarction, angina pectoris, and other cardiovascular conditions. It is manufactured by American Regent and is available in 10 mL preservative-free vials with a concentration of 5 mg/mL[1][4].
Current Market Situation
Drug Shortages
The market for nitroglycerin injection has been impacted by recurring shortages. As of the latest updates, American Regent has nitroglycerin on shortage due to increased demand. This shortage has led to backorders, and the company cannot estimate a release date for the affected products[2][5].
Alternative Products
During the shortage, alternative products from other manufacturers, such as Baxter, are available. These include premixed glass bottles with different concentrations (100 mcg/mL, 200 mcg/mL, and 400 mcg/mL)[2].
Market Dynamics
Demand and Supply
The increased demand for nitroglycerin injection has been a significant factor in the current shortage. This demand is driven by the medication's essential role in managing cardiovascular emergencies. The shortage has disrupted the supply chain, affecting both healthcare providers and patients[2][5].
Competitive Landscape
The market for nitroglycerin injection is not highly competitive due to the specialized nature of the product and the limited number of manufacturers. American Regent and Baxter are among the key players, but the shortage has highlighted the vulnerability of the supply chain when one major manufacturer faces production issues[2].
Price Projections
Impact of Shortages
Shortages typically lead to price volatility. In the case of nitroglycerin injection, the shortage could result in higher prices due to the reduced supply and increased demand. However, price increases are often regulated by healthcare authorities to prevent exploitation.
Historical Pricing
Historical data on pricing for nitroglycerin injection shows that prices can fluctuate based on supply and demand. During periods of normal supply, prices tend to stabilize. However, during shortages, prices may rise temporarily until the supply is restored[5].
Future Pricing Trends
Given the ongoing shortage and the critical nature of the medication, prices for nitroglycerin injection may remain elevated in the short term. Here are some potential pricing trends:
- Short-term: Prices may increase due to the shortage, but regulatory bodies may intervene to cap excessive price hikes.
- Medium-term: Once the supply chain is restored, prices are likely to stabilize or decrease as competition and normal supply dynamics resume.
- Long-term: The trend towards personalized and preventive healthcare, as outlined in broader pharmaceutical industry trends, may influence the pricing of nitroglycerin injection by emphasizing cost-effective and efficient treatment options[3].
Regulatory and Policy Environment
FDA and Health Authorities
Regulatory bodies such as the FDA and health authorities play a crucial role in managing drug shortages and ensuring fair pricing. They may implement measures to expedite the approval of alternative products or impose price controls to mitigate the impact of shortages on patients[2].
Policy Changes
Changes in healthcare policies, especially those related to pharmaceutical pricing and supply chain management, can significantly impact the market for nitroglycerin injection. For instance, policies aimed at reducing drug prices or enhancing supply chain resilience could influence future pricing trends[3].
Clinical and Pharmacological Considerations
Pharmacological Action
Nitroglycerin injection works by relaxing vascular smooth muscle, leading to the dilatation of peripheral arteries and veins. This action reduces preload and afterload, making it a critical medication for managing acute cardiovascular conditions[4].
Clinical Trials and Efficacy
Clinical trials have demonstrated the efficacy of nitroglycerin injection in reducing blood pressure and improving hemodynamic parameters. However, the development of tolerance and potential side effects, such as severe hypotension and headache, must be considered in clinical practice[4].
Conclusion
The market for nitroglycerin injection (NDC: 00517-4810-25) is currently challenged by a shortage due to increased demand. This shortage has significant implications for pricing, with potential short-term price increases. However, regulatory interventions and the eventual restoration of the supply chain are expected to stabilize prices.
Key Takeaways
- Shortage Impact: The current shortage of nitroglycerin injection due to increased demand is affecting prices and availability.
- Alternative Products: Baxter's premixed glass bottles are available as alternatives during the shortage.
- Price Volatility: Prices may increase temporarily due to the shortage but are expected to stabilize once the supply is restored.
- Regulatory Environment: Regulatory bodies play a crucial role in managing shortages and ensuring fair pricing.
- Clinical Importance: Nitroglycerin injection remains a critical medication for managing acute cardiovascular conditions.
FAQs
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What is the current status of the nitroglycerin injection shortage?
- The nitroglycerin injection (5 mg/mL, 10 mL vials) from American Regent is currently on backorder due to increased demand, with no estimated release date[2].
-
Are there alternative products available during the shortage?
- Yes, Baxter offers premixed glass bottles with different concentrations (100 mcg/mL, 200 mcg/mL, and 400 mcg/mL) as alternatives[2].
-
How does the shortage affect the pricing of nitroglycerin injection?
- The shortage can lead to temporary price increases due to reduced supply and increased demand, but regulatory bodies may intervene to control excessive price hikes[5].
-
What are the primary pharmacological actions of nitroglycerin injection?
- Nitroglycerin injection relaxes vascular smooth muscle, leading to the dilatation of peripheral arteries and veins, which reduces preload and afterload[4].
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What are some potential side effects of nitroglycerin injection?
- Common side effects include headache, lightheadedness, and hypotension. Severe side effects can include syncope, crescendo angina, and rebound hypertension[4].
Sources
- Rally Inc. - Nitroglycerin 5 mg / mL Intravenous Injection Single Dose Vial.
- American Society of Health-System Pharmacists (ASHP) - Drug Shortage Detail: Nitroglycerin Injection.
- PwC - Pharma industry trends: Five transformative trends shaping 2025 and beyond.
- DailyMed - Label: NITROGLYCERIN injection, solution.
- American Society of Health-System Pharmacists (ASHP) - Drug Shortage Detail: Nitroglycerin Injection.
