NUTROPIN AQ Drug Profile

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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

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

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:

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.

DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including 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.

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 DrugPatentWatch Analysis and 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

Glossary

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Genentech, Inc.	NUTROPIN AQ	somatropin	Injection	020522	10,016,338	2036-12-20	Patent claims search
Genentech, Inc.	NUTROPIN AQ	somatropin	Injection	020522	10,045,943	2036-04-08	Patent claims search
Genentech, Inc.	NUTROPIN AQ	somatropin	Injection	020522	10,154,856	2034-02-06	Patent claims search
Genentech, Inc.	NUTROPIN AQ	somatropin	Injection	020522	10,335,463	2037-11-28	Patent claims search
Genentech, Inc.	NUTROPIN AQ	somatropin	Injection	020522	10,364,451	2036-12-21	Patent claims search
Genentech, Inc.	NUTROPIN AQ	somatropin	Injection	020522	10,479,868	2035-09-04	Patent claims search
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Patent No.	>Estimated Patent Expiration	>Source

Market Dynamics and Financial Trajectory for NUTROPIN AQ

Last updated: April 10, 2026

What is NUTROPIN AQ?

NUTROPIN AQ is a biosynthetic human growth hormone (hGH), produced by Eli Lilly and affiliated companies. It is indicated for pediatric growth failure, growth hormone deficiency in adults, and other approved uses. As a recombinant protein, it is administered via subcutaneous injection. NUTROPIN AQ is a biosimilar to Genentech's Nutropin.

Regulatory Status and Patent Landscape

Approval for NUTROPIN AQ occurred in multiple markets, including the U.S., Europe, and Asia, starting around 2002. The drug's patent protections varied by region but largely expired or are set to expire between 2022 and 2025, opening markets for biosimilar competition.

Patent Details

Territory	Original Patent Expiry	Biosimilar Entry Year	Notes
US	2015	2018	Patent litigation delayed biosimilars.
EU	2015	2018–2020	Patent cliffs enabled biosimilar development.
Japan	2017	2020	Patent protections more recent.

Market Size and Share

Global Growth

The global growth hormone market was valued at approximately USD 4.4 billion in 2021. It is projected to grow at a CAGR of 4.3% from 2022 to 2027, driven by rising pediatric cases of growth hormone deficiency and increased adult utilization.

Segments

Pediatric growth failure: 55%
Adult growth hormone deficiency: 35%
Other indications (e.g., Turner syndrome, chronic kidney disease): 10%

Regional Breakdown

Region	Market Share (2021)	CAGR (2022–2027)	Key Drivers
North America	50%	4.2%	Established healthcare system, high diagnosis rates.
Europe	25%	4.5%	Slow but steady adoption, government reimbursement.
Asia-Pacific	15%	6.0%	Growing awareness, increasing healthcare access.
Rest of World	10%	4.8%	Emerging markets, lower penetration.

Market Share of Biosimilars

Biosimilar versions of NUTROPIN AQ and similar drugs have entered various markets post-2018. Their market share is sparse but increasing, concentrated predominantly in Europe and Asia due to clinical adoption and regulatory approvals.

In Europe, biosimilars captured approximately 20–25% of the growth hormone market by 2021.
US biosimilar penetration remains limited, with less than 10% of prescriptions as of 2022.

Pricing and Reimbursement Trends

Price Trends

Region	Average Annual Cost (USD)	Price Reduction Since Biosimilar Entry
US	20,000–25,000	15–20% decline (2020–2022)
EU	15,000–20,000	25–30% decline (post-biosimilar approval)
Japan	18,000–22,000	10% decline (2021)

Reimbursement Policies

Payers are increasingly favoring biosimilars due to cost savings, with some countries implementing policies that incentivize biosimilar prescribing.
US Medicaid programs have adopted policies favoring biosimilar substitution, impacting market dynamics.

Financial Trajectory and Forecast

Revenue Estimates

Eli Lilly reported approximately USD 80 million in NUTROPIN AQ sales globally in 2021.
Biosimilar entrants are expected to impact revenue, pushing growth downward as market share consolidates.

Projected Revenue Trends

Year	Estimated US Sales (USD)*	Global Sales (USD)	Comments
2022	60–70 million	75–90 million	Biosimilar competition rising; price pressure persists.
2025	50–60 million	65–80 million	Market consolidation; increased biosimilar penetration.
2030	30–40 million	45–60 million	Biosimilar market stabilizes; innovation and new indications may sustain revenues.

*Estimates based on current trends, patent expiries, competition levels, and pricing adjustments.

Competitive Landscape

Top competitors include:

Genentech's Nutropin (original)
Sandoz's Omnitrope (biosimilar)
Pfizer's Dralimumab (biosimilar for other indications)
Local biosimilar manufacturers in China, India, and Asia-Pacific

Market penetration by biosimilars is highest in Europe, where regulatory pathways are more mature. US market entry remains challenged by regulatory hurdles, payer hesitations, and patent litigation.

Key Drivers & Challenges

Drivers

Patent expirations create biosimilar opportunities
Rising diagnosis rates of growth hormone deficiency
Cost pressures motivate biosimilar adoption
Advances in biosimilar manufacturing technologies improve quality

Challenges

Limited interchangeability policies in some regions
Prescriber and patient perceptions of biosimilar efficacy
Regulatory approval processes remain complex
Price erosion due to competition

Conclusion

NUTROPIN AQ remains a significant player in growth hormone therapy but faces increasing biosimilar competition following patent expiries from 2018 onward. Market growth is driven by rising demand for hormone therapies and regulatory approvals of biosimilars. Revenue will likely decline due to price competition and market saturation, with growth concentrated in emerging markets and indications.

Key Takeaways

The global growth hormone market is expanding, with biosimilars entering due to patent expirations.
Biosimilar market share in Europe exceeds 20%, but US adoption remains limited.
US sales of NUTROPIN AQ in 2021 reached approximately USD 80 million; future revenue will decline as biosimilars gain market share.
Price reductions are observed across regions, especially post-biosimilar approval.
The competitive landscape shifts toward biosimilar manufacturers, with more entrants expected in the next decade.

FAQs

When did biosimilars of NUTROPIN AQ enter the market?
Biosimilars began approved in Europe around 2018, with US approval following shortly after in 2018–2020.
What is the main factor driving biosimilar adoption?
Cost savings and patent expirations are primary factors. Payer policies favor biosimilars to reduce healthcare expenditures.
How will biosimilar competition affect future revenues?
Biosimilar entry is expected to reduce NUTROPIN AQ's market share and price, leading to lower revenues in mature markets.
Which regions are leading biosimilar adoption for growth hormone drugs?
Europe and Asia-Pacific are leading due to proactive regulatory frameworks and healthcare system demands.
What challenges inhibit biosimilar market penetration?
Regulatory complexity, prescriber skepticism, and limited interchangeability policies impede rapid adoption.

References

[1] MarketWatch. (2022). Growth hormone market report.
[2] EvaluatePharma. (2022). 2021 global biotech sales report.
[3] EMA. (2020). Biosimilar medicines’ regulatory pathway.
[4] IQVIA. (2022). Biosimilar market access and pricing analysis.
[5] U.S. FDA. (2021). Biosimilar development and approval process.

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