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Last Updated: December 22, 2024

MINITRAN Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Minitran

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

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Summary for MINITRAN
Drug patent expirations by year for MINITRAN
Drug Sales Revenue Trends for MINITRAN

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Recent Clinical Trials for MINITRAN

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SponsorPhase
Anticancer Fund, BelgiumPhase 2
Maastricht Radiation OncologyPhase 2
Reliable Cancer TherapiesPhase 2

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US Patents and Regulatory Information for MINITRAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch MINITRAN nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 089773-001 Aug 30, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Valeant Pharms North MINITRAN nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 089772-001 Aug 30, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Valeant Pharms MINITRAN nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 089771-001 Aug 30, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Valeant Pharms MINITRAN nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 089774-001 Aug 30, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

MINITRAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Minitran

Introduction

Minitran, a transdermal delivery system containing nitroglycerin, is primarily used for the prevention of angina pectoris in patients with coronary artery disease. Understanding the market dynamics and financial trajectory of Minitran involves examining its clinical use, market positioning, competition, and economic factors.

Clinical Use and Indications

Minitran is indicated for the prophylaxis of angina pectoris, either alone or in combination with other anti-anginal therapies. It is also used for the maintenance of venous patency at peripheral infusion sites[1][2].

Mechanism of Action

Nitroglycerin, the active ingredient in Minitran, acts as a vasodilator, relaxing smooth muscle and reducing myocardial oxygen consumption by affecting venous capacitance and arteriolar resistance vessels. This mechanism is crucial for relieving angina symptoms[1][4].

Market Positioning

Minitran is part of the organic nitrate class, which includes other nitroglycerin-based products. Its transdermal delivery system offers a convenient and continuous release of the medication, making it a preferred option for patients requiring long-term management of angina.

Competitive Landscape

The market for anti-anginal medications is competitive, with various formulations of nitrates and other classes of drugs. Minitran competes with other transdermal nitroglycerin systems, as well as oral and sublingual nitrate preparations. The development of tolerance to continuous nitrate therapy is a significant challenge, which can affect market share and patient adherence[2].

Dosage and Administration

Minitran patches are available in several strengths, including 0.1 mg/hr, 0.2 mg/hr, 0.4 mg/hr, and 0.6 mg/hr. The dosage is typically adjusted based on individual patient response, with recommendations for patch-free intervals to mitigate tolerance development[1][2].

Side Effects and Precautions

Common side effects include headache, flushing, dizziness, and postural hypotension. Patients with hypoxaemia, ventilation-perfusion imbalance, or recent myocardial infarction require cautious use. The potential for cross-tolerance with other nitrates and sensitization phenomena are also important considerations[1].

Economic Factors

Pricing and Profitability

The pricing of Minitran is influenced by its positioning as a prescription drug, the cost of production, and the competitive landscape. Given the specific patient population and the chronic nature of the condition, Minitran can generate significant revenue. However, the development of generic alternatives and the potential for price competition can impact profitability[3].

Research and Development

The economics of drug development, particularly for niche products like Minitran, involve high research and development costs. The shift towards precision medicines and the increasing focus on small patient populations can lead to higher prices due to the value created for these specific conditions[3].

Regulatory and Legal Considerations

Regulatory approvals and compliance with safety and efficacy standards are critical. Additionally, legal issues such as patent protection and generic competition play a significant role in the financial trajectory of Minitran. The ability to maintain market exclusivity through patents can significantly impact revenue[5].

Market Trends

Patient Population and Demand

The demand for Minitran is driven by the prevalence of coronary artery disease and the need for effective angina management. An aging population and increasing incidence of cardiovascular diseases contribute to a stable demand for such medications.

Generic Competition

The potential for generic competition is a significant factor in the market dynamics of Minitran. Once patents expire, generic versions can enter the market, potentially reducing the market share and revenue of the original product[3].

Financial Performance

Revenue Streams

Minitran generates revenue through prescription sales, primarily to patients with coronary artery disease. The revenue is influenced by the number of prescriptions, the dosage strength prescribed, and the pricing strategy.

Cost Structure

The cost structure includes research and development expenses, manufacturing costs, marketing and distribution expenses, and regulatory compliance costs. Efficient management of these costs is crucial for maintaining profitability.

Key Takeaways

  • Clinical Use: Minitran is used for the prevention of angina pectoris and maintenance of venous patency.
  • Market Positioning: It competes in the anti-anginal medication market, particularly among transdermal nitroglycerin systems.
  • Economic Factors: Pricing, profitability, and regulatory considerations are key drivers of its financial trajectory.
  • Market Trends: Demand is driven by the prevalence of coronary artery disease, and generic competition is a significant factor.
  • Financial Performance: Revenue is generated through prescription sales, and cost management is critical for profitability.

FAQs

What is Minitran used for?

Minitran is used for the prophylaxis of angina pectoris and the maintenance of venous patency at peripheral infusion sites.

How does Minitran work?

Minitran works by releasing nitroglycerin, which acts as a vasodilator, reducing myocardial oxygen consumption and relieving angina symptoms.

What are the common side effects of Minitran?

Common side effects include headache, flushing, dizziness, and postural hypotension.

Can Minitran be used continuously without a patch-free interval?

Continuous use without a patch-free interval can lead to tolerance development, reducing the effectiveness of the medication.

How does generic competition affect Minitran’s market share?

Generic competition can significantly reduce Minitran’s market share and revenue once the original product’s patents expire.

Sources

  1. Minitran 5 mg/ 24 h, Transdermal Patch - Medicines.org.uk
  2. Minitran (Nitroglycerin Transdermal Delivery System) - RxList
  3. The Economics of Drug Development: Pricing and Innovation in a Changing Market - NBER
  4. Minitran | Drug Information, Uses, Side Effects, Chemistry - PharmaCompass
  5. Prescription Drug Reimportation in Connecticut - CT.gov

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