DANZITEN Drug Patent Profile

Which patents cover Danziten, and what generic alternatives are available?

Danziten is a drug marketed by Azurity and is included in one NDA. There are two patents protecting this drug.

This drug has six patent family members in five countries.

The generic ingredient in DANZITEN is nilotinib tartrate. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nilotinib tartrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Danziten

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 18, 2040. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DANZITEN

International Patents:	6
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	4,662
What excipients (inactive ingredients) are in DANZITEN?	DANZITEN excipients list
DailyMed Link:	DANZITEN at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DANZITEN

Constraining patent/regulatory exclusivity:

11,793,809

NDA:

219293

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for DANZITEN

Drug Class	Kinase Inhibitor
Mechanism of Action	Bcr-Abl Tyrosine Kinase Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors P-Glycoprotein Inhibitors UGT1A1 Inhibitors

US Patents and Regulatory Information for DANZITEN

DANZITEN is protected by two US patents.

This potential generic entry date is based on patent 11,793,809.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-001	Nov 7, 2024		RX	Yes	No	11,793,809		Y
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-001	Nov 7, 2024		RX	Yes	No	10,874,671		Y
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-002	Nov 7, 2024		RX	Yes	Yes	10,874,671		Y
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-002	Nov 7, 2024		RX	Yes	Yes	11,793,809		Y

International Patents for DANZITEN

When does loss-of-exclusivity occur for DANZITEN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

China

European Patent Office

Japan

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DANZITEN around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3914252	COMPOSITION PHARMACEUTIQUE DU NILOTINIB (PHARMACEUTICAL COMPOSITIONS OF NILOTINIB)
Japan	2022510732	ニロチニブの医薬組成物
Japan	7211644
Spain	2993251
World Intellectual Property Organization (WIPO)	2020172120

Market Dynamics and Financial Trajectory for Pharmaceutical Drugs: A Case Study of the US Pharmaceutical Market

Introduction

The US pharmaceutical market is a complex and dynamic environment, influenced by various factors including regulatory changes, market consolidation, and the bargaining power of key stakeholders. This article will delve into the market dynamics and financial trajectory of pharmaceutical drugs, using the context of the US market and drawing insights from the case of Novo Nordisk.

The US Pharmaceutical Market: An Overview

The US pharmaceutical market is one of the largest and most competitive in the world. It is characterized by a multifaceted value chain involving pharmaceutical manufacturers, Pharmacy Benefit Managers (PBMs), pharmacies, and patients. The market is heavily influenced by the interactions between these stakeholders[1].

Role of Pharmacy Benefit Managers (PBMs)

PBMs act as middlemen between pharmaceutical manufacturers and pharmacies. They negotiate prices and rebates with manufacturers, which significantly impacts the net prices of prescription drugs. The consolidation of PBMs and pharmacies has led to increased bargaining power for these entities, resulting in higher rebates and lower net prices for pharmaceutical companies[1].

Price Dynamics in the US Pharmaceutical Market

The price dynamics in this market are marked by a disconnect between list prices and net prices. While list prices of drugs continue to rise at double-digit growth rates, the net prices (after rebates) have seen lower growth rates. This discrepancy is due to the increasing rebates negotiated by PBMs. However, these rebates do not always translate to lower costs for patients, as insurance premiums continue to rise[1].

Impact on Pharmaceutical Manufacturers

The increased price pressure from PBMs has significant implications for pharmaceutical manufacturers. For instance, Novo Nordisk, a major Danish pharmaceutical company, has experienced this pressure firsthand. In response to the changing market dynamics, Novo Nordisk lowered its expected sales growth rates from 10% to 5% in 2016[1].

Financial Trajectory of Pharmaceutical Companies

The financial trajectory of pharmaceutical companies in the US market is heavily influenced by the evolving price dynamics. Here are some key points:

Revenue and Profitability

• The revenue growth of pharmaceutical companies is impacted by the net prices of their drugs. With lower net prices due to higher rebates, companies may see reduced revenue growth.
• Profitability is also affected as the increased rebates reduce the margin between the list price and the net price[1].

Market Valuation

• The market valuation of pharmaceutical companies can be volatile due to changes in market dynamics. Investors closely watch the ability of companies to maintain or increase their market share and pricing power.
• Companies that adapt quickly to the changing landscape, such as through innovative pricing strategies or diversification of their product portfolio, may see more stable valuations[1].

Research and Development (R&D) Investments

• Despite the financial pressures, pharmaceutical companies must continue to invest in R&D to maintain their competitive edge. This is crucial for developing new drugs and staying relevant in a highly competitive market.
• The return on investment (ROI) from R&D is a key metric for evaluating the financial health and future prospects of pharmaceutical companies[1].

Case Study: Novo Nordisk

Novo Nordisk's experience in the US pharmaceutical market provides valuable insights into the financial trajectory of pharmaceutical companies.

Price Pressure and Revenue Impact

• Novo Nordisk faced increased price pressure from PBMs, leading to lower net prices for its drugs. This resulted in reduced revenue growth and a downward revision of its sales growth expectations[1].

Financial Performance Analysis

• A financial Return on Invested Capital (ROIC) analysis of Novo Nordisk revealed that the company's profitability was impacted by the increased price pressure. The study suggested that the consolidation of PBMs and pharmacies was a significant factor behind this change[1].

Strategic Responses

• In response to the changing market dynamics, Novo Nordisk and other pharmaceutical companies have to adopt strategic measures such as negotiating better rebate terms, diversifying their product portfolios, and investing in innovative pricing models.

Industry Trends and Future Outlook

The US pharmaceutical market is expected to continue evolving, driven by several key trends:

Regulatory Changes

• Regulatory changes, such as those related to drug pricing transparency and the role of PBMs, can significantly impact the market dynamics. Companies need to stay abreast of these changes to navigate the market effectively.

Technological Advancements

• Technological advancements in drug development and delivery can provide new opportunities for growth. Companies that invest in these areas may have a competitive advantage.

Patient-Centric Models

• There is a growing trend towards patient-centric models, where the focus is on delivering value to patients rather than just maximizing profits. This could lead to more sustainable business models for pharmaceutical companies.

Key Takeaways

• The US pharmaceutical market is characterized by complex interactions between manufacturers, PBMs, pharmacies, and patients.
• The consolidation of PBMs and pharmacies has increased their bargaining power, leading to higher rebates and lower net prices for pharmaceutical companies.
• Pharmaceutical companies must adapt to these changes through strategic pricing, R&D investments, and diversification.
• Regulatory changes, technological advancements, and patient-centric models are key trends shaping the future of the industry.

FAQs

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

PBMs act as middlemen between pharmaceutical manufacturers and pharmacies, negotiating prices and rebates. Their consolidation has increased their bargaining power, impacting the net prices of prescription drugs.

How do rebates affect the financial performance of pharmaceutical companies?

Rebates negotiated by PBMs reduce the net prices of drugs, affecting the revenue and profitability of pharmaceutical companies. Despite rising list prices, the net prices have lower growth rates due to these rebates.

What strategic responses can pharmaceutical companies adopt to mitigate price pressure?

Companies can negotiate better rebate terms, diversify their product portfolios, invest in innovative pricing models, and focus on R&D to maintain their competitive edge.

How do regulatory changes impact the US pharmaceutical market?

Regulatory changes related to drug pricing transparency and the role of PBMs can significantly alter market dynamics. Companies must stay updated on these changes to navigate the market effectively.

What is the importance of R&D investments for pharmaceutical companies?

R&D investments are crucial for developing new drugs and maintaining a competitive edge. The ROI from R&D is a key metric for evaluating the financial health and future prospects of pharmaceutical companies.

Sources

1. Hagen, K. I. (2017). The Price Dynamics of the US Pharmaceutical Market: A Case Study of Novo Nordisk. Master Thesis in Economics and Business Administration, Copenhagen Business School.