NITRONAL Drug Patent Profile

When do Nitronal patents expire, and when can generic versions of Nitronal launch?

Nitronal is a drug marketed by Pohl Boskamp and is included in one NDA.

The generic ingredient in NITRONAL is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nitronal

A generic version of NITRONAL was approved as nitroglycerin by AM REGENT on May 24^th, 1988.

Summary for NITRONAL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	1
Patent Applications:	2,449
DailyMed Link:	NITRONAL at DailyMed

Recent Clinical Trials for NITRONAL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Minia University	Phase 1/Phase 2

See all NITRONAL clinical trials

US Patents and Regulatory Information for NITRONAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pohl Boskamp	NITRONAL	nitroglycerin	INJECTABLE;INJECTION	018672-001	Aug 30, 1983		DISCN	No	No

NITRONAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NITRONAL

Introduction

NITRONAL, a formulation of glyceryl trinitrate (nitroglycerin), is a critical medication used in the management of various cardiovascular conditions, including angina pectoris, acute myocardial infarction, and hypertensive crises. Understanding the market dynamics and financial trajectory of NITRONAL is essential for healthcare providers, manufacturers, and investors.

Market Need and Demand

The demand for NITRONAL is driven by its therapeutic efficacy in treating cardiovascular diseases. The medication is indicated for several life-threatening conditions, making it a vital component of emergency and intensive care protocols[1][4].

Supply Chain Challenges

The market for NITRONAL has been impacted significantly by supply chain disruptions. In the United States, critical shortages of nitroglycerin products have been a recurring issue since 2007. These shortages have been attributed to various factors, including manufacturing delays, defects in raw materials, and the discontinuation of products by key manufacturers like Hospira and American Regent[4].

Temporary Importation

To address the shortage, Arbor Pharmaceuticals, in cooperation with the FDA, has initiated the temporary importation of NITRONAL from Germany. This product, manufactured by G. Pohl-Boskamp GmbH & Co. KG, has a different concentration compared to the FDA-approved nitroglycerin products in the US, which can introduce dosing errors and necessitate careful handling by healthcare providers[1][4].

Economic Factors

The market for generic drugs, including NITRONAL, is highly price-sensitive. However, the demand for these drugs is relatively price-insensitive due to their critical nature. Health care facilities often receive capitated payments from health insurers, which can make it difficult to pass on increased costs to consumers. This dynamic can lead to a situation where supply does not increase despite rising demand, exacerbating shortages[4].

Financial Trajectory

Current Market Status

The financial trajectory of NITRONAL is influenced by its role as a lifesaving medication and the ongoing supply chain issues. The temporary importation of NITRONAL has helped alleviate some of the shortage, but it also introduces additional costs related to importation, distribution, and ensuring compliance with FDA regulations[1].

Revenue Impact

The revenue generated from NITRONAL sales is significant due to its widespread use in critical care settings. However, the revenue is also subject to fluctuations based on the availability of the drug. During periods of shortage, the revenue may drop due to reduced supply, while temporary importation can stabilize but also complicate the financial picture due to different pricing and distribution costs[4].

Future Outlook

The long-term financial outlook for NITRONAL depends on several factors, including the resolution of supply chain issues, competition from other vasodilators, and regulatory changes. Diversifying the supply chain and ensuring multiple manufacturers are producing the drug can help stabilize the market and reduce the risk of future shortages. This could lead to more predictable revenue streams for manufacturers and distributors[4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of NITRONAL. The FDA's decision to allow the temporary importation of NITRONAL from Germany highlights the agency's efforts to address critical drug shortages. However, this also underscores the need for stricter regulations and oversight to prevent such shortages in the future[1][4].

Competitive Landscape

The competitive landscape for NITRONAL is characterized by a limited number of manufacturers. In the US, the market is dominated by a few key players, including Arbor Pharmaceuticals, which is currently distributing the imported NITRONAL. The lack of competition can exacerbate supply chain issues and limit pricing flexibility[1][4].

Patient and Provider Impact

The impact of NITRONAL shortages on patients and healthcare providers is significant. Shortages can lead to rationing of the drug, delayed treatments, and increased risk of medication errors due to the use of alternative products with different concentrations. This underscores the need for a reliable and stable supply chain to ensure continuous access to this critical medication[4].

Key Takeaways

• Critical Need: NITRONAL is essential for treating various cardiovascular conditions.
• Supply Chain Issues: Recurring shortages due to manufacturing delays and raw material shortages.
• Temporary Importation: FDA-approved importation of NITRONAL from Germany to address shortages.
• Economic Factors: Price-sensitive market with relatively price-insensitive demand.
• Financial Trajectory: Revenue impacted by supply chain issues and temporary importation costs.
• Regulatory Environment: FDA oversight crucial in managing shortages and ensuring compliance.
• Competitive Landscape: Limited competition exacerbates supply chain vulnerabilities.

FAQs

1. What is NITRONAL used for? NITRONAL is used for treating angina pectoris, acute myocardial infarction, acute left ventricular failure, controlled hypotension, and other cardiovascular conditions[1].

2. Why is there a shortage of NITRONAL in the US? The shortage is due to manufacturing delays, defects in raw materials, and the discontinuation of products by key manufacturers[4].

3. How is the FDA addressing the NITRONAL shortage? The FDA has allowed the temporary importation of NITRONAL from Germany to address the critical shortage[1].

4. What are the risks associated with using imported NITRONAL? The imported product has a different concentration, which can introduce dosing errors and medication errors if not handled carefully[1][4].

5. How does the supply chain impact the financial trajectory of NITRONAL? The supply chain issues can lead to fluctuations in revenue due to reduced supply and additional costs associated with importation and distribution[4].

Sources

1. Nitronal: Package Insert / Prescribing Information - Drugs.com
2. NITRONAL Advanced Patient Information - Drugs.com
3. The Impact of Drug Shortages on Patients with Cardiovascular Diseases - American Heart Association
4. The Price of Progress: Understanding Innovation and Affordability of Prescription Drugs - AJMC
5. Incretin-Based Drugs Market Statistics, Forecast - 2032 - Allied Market Research (not directly relevant but provides context on drug market dynamics)