NUTROPIN AQ Drug Profile

Summary for Tradename: NUTROPIN AQ

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for NUTROPIN AQ
Recent Clinical Trials:	See clinical trials for NUTROPIN AQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NUTROPIN AQ

See drug prices for NUTROPIN AQ

Recent Clinical Trials for NUTROPIN AQ

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Rochester	Phase 1
Genentech, Inc.	Phase 4
Center for Human Reproduction	Phase 1/Phase 2

See all NUTROPIN AQ clinical trials

Recent Litigation for NUTROPIN AQ

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

See all NUTROPIN AQ litigation

PTAB Litigation

Petitioner	Date
	2017-05-19

See all NUTROPIN AQ litigation

Pharmacology for NUTROPIN AQ

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 NUTROPIN AQ Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for NUTROPIN AQ 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
Genentech, Inc.	NUTROPIN AQ	somatropin	Injection	020522		2033-03-11	Patent claims search
Genentech, Inc.	NUTROPIN AQ	somatropin	Injection	020522		2034-11-02	Patent claims search
Genentech, Inc.	NUTROPIN AQ	somatropin	Injection	020522		2033-02-06	Patent claims search
Genentech, Inc.	NUTROPIN AQ	somatropin	Injection	020522		2030-12-23	Patent claims search

Market Dynamics and Financial Trajectory for Nutropin AQ

Introduction

Nutropin AQ, a recombinant human growth hormone developed by Genentech, is a crucial treatment for various growth-related disorders. Understanding the market dynamics and financial trajectory of this biologic drug is essential for stakeholders, including patients, healthcare providers, and investors.

Indications and Usage

Nutropin AQ is indicated for the treatment of growth hormone deficiency (GHD) in both pediatric and adult patients, as well as for idiopathic short stature, Turner syndrome, and chronic kidney disease up to the time of renal transplantation[4].

Market Demand and Supply

The demand for Nutropin AQ has seen significant fluctuations, leading to supply shortages. As of August 2023, Genentech anticipated a supply shortage for Nutropin AQ NuSpin® 5 mg, 10 mg, and 20 mg formulations in the United States due to a sustained increase in demand and supply chain issues across several growth hormone manufacturers[1].

Impact of Shortages

The shortage has critical implications for patients and healthcare providers, potentially leading to delays in refilling prescriptions and necessitating discussions about alternative treatment options. Genentech advises against starting treatment-naive patients on Nutropin AQ during this period and recommends considering alternative growth hormones based on clinical judgment and market availability[1].

Financial Performance

Historical Sales

Nutropin AQ has been a significant contributor to Genentech's revenue. In 2003, the combined net sales of Genentech's four growth hormone products, including Nutropin AQ, were $322 million, representing an 8% increase from 2002. This growth was driven by continued strong demand for Nutropin products[3].

Revenue Contribution

Growth hormone products, including Nutropin AQ, have consistently contributed to Genentech's overall revenue. For instance, in the late 1990s and early 2000s, growth hormone sales were a notable part of Genentech's product portfolio, although they were sometimes offset by declines in other product sales, such as Activase[2][3].

Competitive Landscape

Market Competition

The market for growth hormone therapies is competitive, with several products available. However, the entry of follow-on biologics (biosimilars) has been slower and less impactful compared to conventional generic drugs. This is due to high fixed costs of entry, limited perceived substitutability between innovator biologics and biosimilars, and structural limitations in the distribution system[5].

Pricing Strategies

Competitors like Tev-Tropin have adopted price-based competitive strategies, but these have had minimal impact on market share and average prices. The unique characteristics of biologic drugs and the complexities of their development and approval processes contribute to this dynamic[5].

Financial Trajectory

Revenue Growth

Genentech has experienced significant revenue growth over the years, partly driven by the success of its growth hormone products. In 2003, Genentech reported a 28% increase in revenue to over $3 billion, with non-GAAP earnings per share growing by 30% to $1.20[3].

Cost Management and Productivity

Despite the growth, Genentech has focused on managing costs and improving productivity. The company aims to decrease expenses as a percentage of revenues as revenues increase with new product introductions. This strategy is crucial for maintaining profitability and competitiveness in the biopharmaceutical industry[2].

Future Outlook

Supply Stability

Genentech anticipates that the current supply issues for Nutropin AQ will persist for several months but expects a return to supply stability in the first half of 2024. Proactive communication and efforts to make the product available as quickly and widely as possible are ongoing[1].

Pipeline and Innovations

Genentech continues to invest in its development pipeline, ensuring a steady flow of innovative products. This includes collaborations with other companies to develop new molecular entities, which will be crucial for long-term growth and market dominance[3].

Key Takeaways

• Market Demand: High demand for Nutropin AQ has led to supply shortages, affecting patients and healthcare providers.
• Financial Performance: Nutropin AQ has been a significant revenue contributor to Genentech, with steady growth in sales over the years.
• Competitive Landscape: The market is competitive, but the impact of biosimilars is limited due to various market and regulatory factors.
• Future Outlook: Genentech is working to restore supply stability and continues to invest in its development pipeline.

FAQs

What is Nutropin AQ used for?

Nutropin AQ is used for the treatment of growth hormone deficiency in children and adults, as well as for idiopathic short stature, Turner syndrome, and chronic kidney disease up to the time of renal transplantation[4].

Why is there a shortage of Nutropin AQ?

The shortage is due to a significant and sustained increase in demand and supply chain issues across several growth hormone manufacturers[1].

How does the shortage affect patients and healthcare providers?

The shortage may cause delays in refilling prescriptions and necessitate discussions about alternative treatment options. Genentech advises against starting treatment-naive patients on Nutropin AQ during this period[1].

What are the financial implications of Nutropin AQ for Genentech?

Nutropin AQ has been a significant contributor to Genentech's revenue, with steady growth in sales over the years. However, the current shortage may impact short-term revenue stability[3].

What is the future outlook for Nutropin AQ supply?

Genentech anticipates a return to supply stability in the first half of 2024 and is working to make the product available as quickly and widely as possible[1].

How does the competitive landscape affect Nutropin AQ?

The market for growth hormone therapies is competitive, but the impact of biosimilars is limited due to high fixed costs of entry and structural limitations in the distribution system[5].

Sources

1. Genentech - Nutropin Shortage
2. Genentech - 1998 Annual Report
3. Genentech - 2003 Annual Report
4. Nutropin - Nutropin AQ Monthly Therapy Tracker
5. Duke University - The Effect on Federal Spending of Legislation Creating a Regulatory Pathway for Follow-on Biologic Drugs