NORDITROPIN Drug Profile

Summary for Tradename: NORDITROPIN

High Confidence Patents:	14
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for NORDITROPIN
Recent Clinical Trials:	See clinical trials for NORDITROPIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NORDITROPIN

See drug prices for NORDITROPIN

Recent Clinical Trials for NORDITROPIN

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Xiamen Amoytop Biotech Co., Ltd.	Phase 2/Phase 3
Tongji Hospital	Phase 2/Phase 3
Children's Hospital Medical Center, Cincinnati	Phase 1/Phase 2

See all NORDITROPIN clinical trials

Recent Litigation for NORDITROPIN

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.	2023-01-19
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN INC.	2021-07-28
SMITH v. NOVO NORDISK INC.	2016-08-08

See all NORDITROPIN litigation

PTAB Litigation

Petitioner	Date
	2017-05-19

See all NORDITROPIN litigation

Pharmacology for NORDITROPIN

Established Pharmacologic Class	Recombinant Human Growth Hormone
Chemical Structure	Human Growth Hormone

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 NORDITROPIN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for NORDITROPIN 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.	NORDITROPIN	somatropin	Injection	021148			Company disclosures
Novo Nordisk Inc.	NORDITROPIN	somatropin	Injection	021148		2014-05-06	Company disclosures
Novo Nordisk Inc.	NORDITROPIN	somatropin	Injection	021148			Company disclosures

3) Low Certainty: US Patents for NORDITROPIN 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.	NORDITROPIN	somatropin	Injection	021148		2033-03-11	Patent claims search
Novo Nordisk Inc.	NORDITROPIN	somatropin	Injection	021148		2034-11-02	Patent claims search
Novo Nordisk Inc.	NORDITROPIN	somatropin	Injection	021148		2033-02-06	Patent claims search

International Patents for NORDITROPIN

Country	Patent Number	Estimated Expiration
European Patent Office	0608343
Japan	3270761
Spain	2334046

NORDITROPIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of NORDITROPIN

Introduction

NORDITROPIN, a human growth hormone (hGH) product developed by Novo Nordisk, is a significant player in the global hGH market. This article delves into the market dynamics and financial trajectory of NORDITROPIN, highlighting key factors driving its growth and the broader industry trends.

Global Human Growth Hormone Market Overview

The global human growth hormone market is experiencing robust growth, driven by increasing incidence of growth hormone deficiencies and the introduction of innovative therapies. The market was valued at USD 6.32 billion in 2023 and is projected to grow at a CAGR of 12.3% from 2024 to 2030, reaching USD 14.28 billion by 2030[1].

Market Segmentation and Growth Drivers

Growth Hormone Deficiency Segment

The growth hormone deficiency segment dominates the market and is expected to grow at the fastest rate during the forecast period. Early diagnosis and treatment, along with innovative therapies, are key drivers of this segment's growth. For instance, the recent approval of once-weekly Sogroya (somapacitan) for the treatment of growth hormone deficiency in children and adolescents underscores the potential for long-acting preparations like NORDITROPIN[1].

Long-Acting Preparations

Long-acting hGH preparations, such as NORDITROPIN, are gaining traction due to their convenience, reduced frequency of administration, and improved patient compliance. These factors are crucial in augmenting segment uptake and driving market expansion[1].

Regional Market Dynamics

North America

North America leads the global hGH market, with a revenue share of 42.27% in 2023. This dominance is attributed to growing healthcare awareness, significant government initiatives, and favorable reimbursement policies in the region. The presence of major pharmaceutical companies, including Novo Nordisk, further supports the region's lucrative market share[1].

Asia Pacific

The Asia Pacific region is anticipated to experience a lucrative growth rate, driven by the high disease burden of rare genetic conditions, unmet medical needs, and the increasing demand for innovative therapeutics. Rising investments by leading market participants in this region are expected to support market expansion[1].

Product Launches and Pipeline

Novo Nordisk has been actively expanding its product portfolio and pipeline. For example, the EC approval for SKYTROFA in 2022 for the treatment of children and adolescents with growth failure highlights the company's commitment to innovative therapies. Additionally, the positive development and recommendation for Sogroya (somapacitan) further solidify NORDITROPIN's position in the market[1].

Financial Performance of Novo Nordisk

Revenue Growth

Novo Nordisk has reported strong sales growth, with net sales increasing by 31% to DKK 232.261 billion in 2023. This growth is largely driven by the company's diabetes and obesity care segment, which saw a 38% increase in sales in Danish kroner[5].

Operating Profit and Net Profit

The company's operating profit grew by 37% to DKK 102.574 billion, and the net profit margin increased to 36.0% in 2023. These financial metrics indicate a robust financial trajectory for Novo Nordisk, which in turn supports the growth of its hGH products like NORDITROPIN[5].

Research and Development

Novo Nordisk has been investing heavily in research and development, with R&D costs increasing to 14.0% of sales in 2023. This investment is crucial for maintaining a strong pipeline and introducing innovative therapies, including those in the hGH segment[5].

Competitive Landscape

The hGH market is highly competitive, with key players such as Pfizer Inc., Eli Lilly and Company, Merck & Co., Inc., and Novartis AG. Novo Nordisk, however, maintains a strong position through its extensive product portfolio and continuous innovation. Emerging players like OPKO Health, Inc. are also expanding their footprint through mergers and acquisitions[1].

Supply Chain and Production Capacity

To meet the increasing demand for its products, Novo Nordisk has been investing in expanding its production capacity. In 2023, the company announced investments totaling more than DKK 75 billion to enhance its supply chain and serve millions more patients worldwide[3].

Regulatory Environment

The regulatory environment plays a critical role in the growth of hGH products. Recent approvals and favorable statements from regulatory bodies, such as the European Medicines Agency's recommendation for Sogroya, are significant drivers of market growth[1].

Patient Compliance and Convenience

Long-acting preparations like NORDITROPIN offer improved patient compliance due to reduced administration frequency. This convenience is a key factor in the segment's growth, as it aligns with patient preferences and improves treatment outcomes.

Future Outlook

The future outlook for NORDITROPIN and the broader hGH market is promising. With ongoing research, new product launches, and expanding production capacity, Novo Nordisk is well-positioned to continue its market dominance. The increasing awareness about growth hormone deficiencies and the need for early diagnosis and treatment further support the market's growth trajectory.

Key Takeaways

• The global human growth hormone market is expected to grow at a CAGR of 12.3% from 2024 to 2030.
• NORDITROPIN benefits from the growth in the long-acting hGH segment due to its convenience and improved patient compliance.
• North America leads the market, while the Asia Pacific region is expected to experience significant growth.
• Novo Nordisk's strong financial performance and investments in R&D and production capacity support the growth of NORDITROPIN.
• Regulatory approvals and favorable reimbursement policies are crucial drivers of market growth.

FAQs

What is the current market size of the global human growth hormone market?

The global human growth hormone market was valued at USD 6.32 billion in 2023[1].

What is the expected CAGR of the global human growth hormone market from 2024 to 2030?

The market is expected to grow at a CAGR of 12.3% from 2024 to 2030[1].

Which region dominates the global human growth hormone market?

North America leads the global hGH market with a revenue share of 42.27% in 2023[1].

What are the key drivers of the growth hormone deficiency segment?

Increasing awareness about early diagnosis and treatment, along with innovative therapies, drive the growth of this segment[1].

How is Novo Nordisk expanding its production capacity?

Novo Nordisk has announced investments totaling more than DKK 75 billion to enhance its production capacity and serve millions more patients worldwide[3].

Sources

1. Grand View Research - Human Growth Hormone Market Size & Share Report, 2030
2. Novo Nordisk - Financial report for the period 1 January 2021 to 31 December 2021
3. Novo Nordisk - Novo Nordisk Annual Report 2023
4. Government of Canada - Biologics in Canada. Part 1: Market Trends, 2018
5. GlobeNewswire - Financial report for the period 1 January 2023 to 31 December 2023