NOVOEIGHT Drug Profile

Summary for Tradename: NOVOEIGHT

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for NOVOEIGHT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NOVOEIGHT

Recent Clinical Trials for NOVOEIGHT

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Novo Nordisk A/S	Phase 1
Novo Nordisk A/S

See all NOVOEIGHT clinical trials

Recent Litigation for NOVOEIGHT

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-11-10
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-05-12
Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc.	2018-05-31

See all NOVOEIGHT litigation

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for NOVOEIGHT Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for NOVOEIGHT Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466		2017-06-20	Company disclosures
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466			Company disclosures
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466			Company disclosures
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466			Company disclosures
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466			Company disclosures
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466			Company disclosures
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466			Company disclosures

3) Low Certainty: US Patents for NOVOEIGHT Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466		2039-02-26	Patent claims search
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466		2039-02-26	Patent claims search
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466		2039-02-26	Patent claims search
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466		2033-04-24	Patent claims search

NOVOEIGHT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NovoEight

Introduction

NovoEight, a recombinant factor VIII product, is a key component of Novo Nordisk's biopharmaceutical portfolio, particularly in the treatment of haemophilia A. Here, we will delve into the market dynamics and financial trajectory of NovoEight, highlighting its performance, market share, and future outlook.

Haemophilia Market Overview

The haemophilia market is a significant segment within the broader biologics industry, driven by the need for effective treatments for haemophilia A and B. This market is characterized by high barriers to entry due to stringent regulatory requirements and the complexity of developing and manufacturing these biologic products[5].

NovoEight's Position in the Market

NovoEight is part of Novo Nordisk's haemophilia franchise, which includes other products like NovoSeven and Refixia. Here are some key points about NovoEight's market position:

Global Launch and Expansion

NovoEight has been launched in numerous countries, with a significant global rollout. As of 2019, it was available in 46 countries, contributing to Novo Nordisk's strong presence in the haemophilia treatment market[5].

Sales Performance

The sales performance of NovoEight is closely tied to the overall haemophilia segment. While specific sales figures for NovoEight are not always isolated, the haemophilia segment as a whole has experienced fluctuations. For instance, in the first quarter of 2019, haemophilia sales declined by 3%, primarily due to an 11% decline in NovoSeven sales. However, this decline was partially offset by the global rollout of NovoEight and the launch of Refixia in 14 countries[5].

Market Share

Novo Nordisk maintains a strong market share in the haemophilia segment. Although the exact market share of NovoEight is not separately disclosed, the company's overall haemophilia franchise remains competitive. The decline in NovoSeven sales has been mitigated by the growth of other products like NovoEight and Refixia[5].

Financial Trajectory

Revenue Contribution

NovoEight contributes to the revenue of Novo Nordisk's rare blood disorders segment. In the first quarter of 2024, the rare blood disorders segment, which includes NovoEight, saw a 4% decline in sales, driven by declines in NovoSeven and haemophilia A sales, partially countered by increased haemophilia B sales[1].

Cost and Pricing Dynamics

The financial performance of NovoEight is influenced by various factors, including production costs, pricing strategies, and reimbursement policies. The biologics market, in general, is subject to pricing pressures, but Novo Nordisk's strong market position and broad product portfolio help mitigate these effects[3].

Research and Development

Novo Nordisk continues to invest in research and development (R&D) to enhance its haemophilia products, including NovoEight. The company's R&D expenses have been significant, reflecting its commitment to innovation and pipeline advancement. For example, in 2018, R&D costs accounted for 13.2% of Novo Nordisk's sales[2].

Market Drivers and Challenges

Market Drivers

• Increasing Prevalence of Haemophilia: The growing awareness and diagnosis of haemophilia A and B drive the demand for effective treatments like NovoEight.
• Technological Advancements: Continuous improvements in biologic drug delivery systems and treatment protocols enhance the efficacy and safety of products like NovoEight[3].
• Regulatory Approvals: The approval of new indications and the expansion of existing ones by regulatory agencies like the FDA and EMA support market growth[2].

Market Challenges

• Competition: The haemophilia market is competitive, with other major players offering similar products. This competition can lead to pricing pressures and market share challenges.
• Regulatory Hurdles: The development and approval of biologic drugs are highly regulated, posing significant barriers to entry and expansion[5].

Future Outlook

Market Growth

The biologics market, including the haemophilia segment, is expected to grow significantly. The overall biologics market is projected to reach USD 699.5 billion by 2032, driven by factors such as the increasing burden of chronic diseases and advancements in biologic therapies[3].

Novo Nordisk's Strategy

Novo Nordisk's strategy to maintain market leadership includes a focus on commercial execution, internal and external innovation, and the addition of complementary assets to its portfolio. The company aims to continue its 'return to growth' strategy, which includes expanding its product offerings and enhancing its pipeline[2].

Key Takeaways

• Strong Market Position: NovoEight is a key product in Novo Nordisk's haemophilia franchise, with a significant global presence.
• Financial Performance: The financial trajectory of NovoEight is influenced by the overall performance of the haemophilia segment and Novo Nordisk's broader biopharmaceutical portfolio.
• Market Drivers: The market is driven by the increasing prevalence of haemophilia, technological advancements, and regulatory approvals.
• Challenges: The market faces challenges such as competition and regulatory hurdles.

FAQs

What is NovoEight used for?

NovoEight is used for the treatment of haemophilia A, a genetic disorder that impairs the body's ability to make blood clots.

How has NovoEight performed in terms of sales?

NovoEight's sales performance is part of the broader haemophilia segment, which has seen fluctuations. While specific figures for NovoEight are not always disclosed, the product has contributed to Novo Nordisk's overall haemophilia sales.

What are the key drivers of the haemophilia market?

Key drivers include the increasing prevalence of haemophilia, technological advancements in biologic drug delivery systems, and regulatory approvals.

What challenges does NovoEight face in the market?

NovoEight faces challenges such as competition from other biologic products and regulatory hurdles that are inherent in the development and approval of biologic drugs.

What is the future outlook for NovoEight and the haemophilia market?

The biologics market, including the haemophilia segment, is expected to grow significantly, driven by increasing demand for effective treatments and advancements in biologic therapies. Novo Nordisk's strategy to focus on commercial execution, innovation, and pipeline advancement is expected to support the continued growth of NovoEight.

Sources

1. Novo Nordisk Investor Presentation Q1 2024
2. Novo Nordisk Investor Presentation Full Year 2018
3. Biologics Market Size to Reach USD 699.5 Billion by 2032
4. Obesity Drugs: Can New Firms Take Market Share From Eli Lilly and Novo Nordisk?
5. Novo Nordisk Investor Presentation First Quarter 2019