GONITRO Drug Patent Profile

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

Gonitro is a drug marketed by Pohl Boskamp and is included in one NDA. There is one patent protecting this drug.

This drug has thirteen patent family members in six countries.

The generic ingredient in GONITRO 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 Gonitro

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

Summary for GONITRO

International Patents:	13
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	36
Patent Applications:	2,584
Drug Prices:	Drug price information for GONITRO
What excipients (inactive ingredients) are in GONITRO?	GONITRO excipients list
DailyMed Link:	GONITRO at DailyMed

See drug prices for GONITRO

US Patents and Regulatory Information for GONITRO

GONITRO is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pohl Boskamp	GONITRO	nitroglycerin	POWDER;SUBLINGUAL	208424-001	Jun 8, 2016		DISCN	Yes	No	9,101,592		Y

International Patents for GONITRO

See the table below for patents covering GONITRO around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	2678000
Spain	2672261
Spain	2565632
World Intellectual Property Organization (WIPO)	2012113564
Canada	2827714	CONDITIONNEMENT DE PREPARATIONS PHARMACEUTIQUES SOLIDES CONTENANT LA SUBSTANCE ACTIVE TRINITRATE DE GLYCERYLE (PACKAGING OF SOLID PHARMACEUTICAL PREPARATIONS CONTAINING THE ACTIVE SUBSTANCE GLYCERYL TRINITRATE)
Australia	2012219925	Packaging of solid pharmaceutical preparations containing the active substance glyceryl trinitrate
World Intellectual Property Organization (WIPO)	2012113563

GONITRO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory in the Pharmaceutical Industry: Lessons from Novo Nordisk and Generic Drug Markets

Introduction

The pharmaceutical industry is a complex and dynamic market influenced by various factors, including regulatory changes, consumer demand, and the bargaining power of intermediaries. This article will delve into the market dynamics and financial trajectories of pharmaceutical companies, using Novo Nordisk and the generic drug industry as case studies.

The Role of Pharmacy Benefit Managers (PBMs)

In the US pharmaceutical market, Pharmacy Benefit Managers (PBMs) play a crucial role as intermediaries between pharmaceutical manufacturers and consumers. The consolidation of PBMs and pharmacies has significantly altered market dynamics, shifting bargaining power from manufacturers to PBMs. This shift has resulted in increased price pressure on drug manufacturers, as PBMs negotiate larger rebates, even though list prices continue to rise at double-digit rates[1].

Impact on Pharmaceutical Manufacturers

Novo Nordisk Case Study

Novo Nordisk, a leading manufacturer of anti-diabetic drugs, has experienced this price pressure firsthand. Despite being a market leader in a highly oligopolistic market with significant monopoly power due to active patents, Novo Nordisk has faced reduced growth targets for sales and operating profit. The company's Return on Invested Capital (ROIC) remained high, but the increased price pressure led to large share price drops and a reduction in expected sales growth rates from 10% to 5% in 2016[1].

Generic Drug Industry Dynamics

Competition and Price Reduction

The generic drug industry provides a unique insight into how competition affects market dynamics. Studies have shown that generic drug prices decrease as the number of competitors increases. Prices for the initial generic monopolist are 35-50% above long-run marginal costs but approach these costs when there are eight or more competitors. This competition leads to a reduction in price-cost margins over time[3].

Entry and Market Size

More firms enter markets with greater expected rents, and the size and time paths of generic revenues and profits are significantly influenced by expected market size. The entry process is quicker in markets with higher expected rents, indicating that companies are more inclined to enter lucrative markets[3].

Financial Trajectory of Pharmaceutical Companies

Revenue and Profitability

The financial performance of pharmaceutical companies can be highly volatile due to market dynamics. For instance, Novo Nordisk's financial statements show a significant increase in ROIC from 99% in 2014 to 145% in 2016, largely due to its market leadership and monopoly power in the anti-diabetic market. However, the company's growth targets were adjusted downward due to increased price pressure[1].

Consumer Demand and Market Opportunity

Obesity Drugs Market

The market for obesity drugs, such as GLP-1 agonists like Ozempic®, illustrates the impact of consumer demand on market dynamics. A recent survey indicated that 16% of Americans would be willing to pay more than $500 a month out of pocket for these drugs, highlighting a significant private pay market opportunity. This demand, coupled with shortages and online purchasing, has driven the market size estimates to between $30 billion and $100 billion, making it a highly lucrative sector[4].

Regulatory Influences

FDA Policies and Generic Drug Industry

Regulatory changes can significantly impact the pharmaceutical industry. For example, the FDA's increased scrutiny of generic drug applications in the late 1980s raised the cost of obtaining an Abbreviated New Drug Application (ANDA), affecting the entry of new generic drugs into the market. This policy change had a direct impact on generic prices and the overall competitiveness of the market[3].

Financial Metrics and Performance

Subscription-Based Models

Companies like Nitro, which operate in the software and document management sector but can be analogously compared to subscription models in pharma, show robust financial performance through subscription revenue growth. Nitro's annual reports highlight significant growth in Annual Recurring Revenue (ARR), subscription revenue, and customer retention rates, demonstrating the stability and growth potential of subscription-based models[2][5].

Key Takeaways

• Bargaining Power Shift: The consolidation of PBMs and pharmacies has shifted bargaining power from pharmaceutical manufacturers to intermediaries, increasing price pressure.
• Competition and Prices: In the generic drug industry, increased competition leads to lower prices, approaching long-run marginal costs with eight or more competitors.
• Consumer Demand: High consumer demand, as seen in the obesity drugs market, can drive significant market opportunities and financial growth.
• Regulatory Impact: Regulatory changes, such as FDA policies, can affect the cost of entry and competition in the pharmaceutical market.
• Financial Performance: Companies with strong market positions and subscription-based models can maintain high profitability despite market pressures.

FAQs

What is the role of Pharmacy Benefit Managers (PBMs) in the US pharmaceutical market?

PBMs act as intermediaries between pharmaceutical manufacturers and consumers, negotiating prices and rebates. Their consolidation has increased their bargaining power, leading to higher price pressure on manufacturers.

How does competition affect prices in the generic drug industry?

Competition in the generic drug industry leads to lower prices as the number of competitors increases. Prices approach long-run marginal costs when there are eight or more competitors.

What is the impact of consumer demand on the pharmaceutical market?

High consumer demand, as seen in the obesity drugs market, can drive significant market opportunities and financial growth. Consumers willing to pay out of pocket for certain drugs can create large private pay market opportunities.

How do regulatory changes affect the pharmaceutical industry?

Regulatory changes, such as increased FDA scrutiny of generic drug applications, can raise the cost of entry and affect competition, leading to changes in generic prices and market dynamics.

What financial metrics are important for pharmaceutical companies?

Key financial metrics include Return on Invested Capital (ROIC), Annual Recurring Revenue (ARR), subscription revenue growth, and customer retention rates, which indicate the financial health and growth potential of pharmaceutical companies.

Sources

1. Hagen, K. I. (2017). The Price Dynamics of the US Pharmaceutical Market: A Case Study of Novo Nordisk. Copenhagen Business School.
2. Nitro (2022). 2021 Annual Report. Nitro.
3. Reiffen, D., & Ward, M. R. (2002). Generic Drug Industry Dynamics. Federal Trade Commission.
4. Stifel (2023). Obesity Drug Review. Stifel.
5. Nitro (2021). 2020 Annual Report. Nitro.