HUMATROPE Drug Profile

Summary for Tradename: HUMATROPE

High Confidence Patents:	3
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for HUMATROPE
Recent Clinical Trials:	See clinical trials for HUMATROPE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HUMATROPE

See drug prices for HUMATROPE

Recent Clinical Trials for HUMATROPE

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Columbia University	Phase 1
Albert Einstein College of Medicine	Phase 1
University of Rochester	Phase 1

See all HUMATROPE clinical trials

Recent Litigation for HUMATROPE

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 HUMATROPE litigation

PTAB Litigation

Petitioner	Date
	2017-05-19

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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 HUMATROPE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	5,334,162		Company disclosures
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	5,383,865		Company disclosures
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	5,454,786	2013-03-15	Company disclosures

3) Low Certainty: US Patents for HUMATROPE 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
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	10,016,338	2033-03-11	Patent claims search
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	10,045,943	2034-11-02	Patent claims search
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	10,154,856	2033-02-06	Patent claims search
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	10,335,463	2030-12-23	Patent claims search
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	10,364,451	2033-05-30	Patent claims search
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	10,479,868	2034-09-04	Patent claims search

International Patents for HUMATROPE

Country	Patent Number	Estimated Expiration
Czech Republic	273096
China	1099301
Slovenia	0615762
Japan	2824151
Yugoslavia	11294
Greece	3030530

HUMATROPE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Humatrope

Market Overview of Human Growth Hormone (hGH) Drugs

The global market for Human Growth Hormone (hGH) drugs is experiencing significant growth, driven by increasing demand and advancements in treatment options. As of 2022, the global hGH drugs market was estimated at $3.5 billion and is projected to reach $4.8 billion by 2030, growing at a CAGR of 4% over the analysis period[1].

Humatrope in the hGH Market

Humatrope, a recombinant human growth hormone (rhGH) product developed by Eli Lilly and Company, is one of the leading brands in the hGH market. Here are some key points about Humatrope and its market dynamics:

Market Share and Sales

Humatrope is among the top-selling hGH products globally. In 2020, it was one of the leading recombinant hGH products, along with Genotropin, Norditropin, Nutropin, and Saizen, in terms of annual sales[1].

Route of Administration

Humatrope is administered via the subcutaneous route, which is the dominant route in the hGH drugs market. The subcutaneous segment is projected to record a 4.5% CAGR and reach $3.1 billion by the end of the analysis period 2022-2030[1].

Applications

Humatrope is used to treat various conditions, including growth hormone deficiency (GHD) in children and adults, Turner syndrome, idiopathic short stature, and Prader-Willi syndrome. The growth hormone deficiency application leads the hGH drugs market, with pediatric GHD being a significant segment[1][3].

Geographic Performance

North America and Europe

North America and Europe are the dominant regions for the hGH market, with the U.S. market estimated at $1.4 billion in 2022. These regions are expected to continue their strong market presence, although the Asia-Pacific region is forecast to witness the fastest growth[1].

Emerging Markets

China, in particular, is forecast to grow at a CAGR of 5.8% over the analysis period, presenting a significant opportunity for growth hormone products like Humatrope[1].

Market Trends and Drivers

High Prevalence of GHD

The increasing prevalence of growth hormone deficiency disorders is a key driver for the market. Growing awareness about GHD and its treatments is also boosting demand for products like Humatrope[1][3].

Long-Acting hGH Drugs

The approval of long-acting hGH drugs, such as Novo Nordisk's once-weekly Sogroya, is transforming the market landscape. These innovations are expected to enhance patient compliance and reduce the frequency of injections, which could further drive the adoption of Humatrope and similar products[1].

Innovation and R&D

Strong innovation and research and development activities in the hGH industry are crucial for market growth. Manufacturers are focusing on novel drug delivery technologies, including needle-less systems, to improve patient outcomes and convenience[1].

Challenges and Restraints

High Cost of Treatment

One of the major restraints for the hGH market is the high cost of treatment. The expensive nature of growth hormone replacement therapy can limit access, especially in regions with lower healthcare budgets[1][3].

Biosimilars and Patent Expiry

The expiry of patents for several hGH products paves the way for the emergence of biosimilars, which could erode revenue growth for branded products like Humatrope. However, this also presents opportunities for companies to develop biosimilar versions of their own products[1].

Financial Performance and Projections

While specific financial data for Humatrope is not provided in the sources, the overall financial trajectory of the hGH market is positive. The market's growth is driven by increasing demand, innovative products, and expanding geographic reach.

Key Takeaways

• Market Growth: The global hGH drugs market, including Humatrope, is projected to grow from $3.5 billion in 2022 to $4.8 billion by 2030.
• Dominant Regions: North America and Europe are the leading regions, with the Asia-Pacific region showing the fastest growth.
• Key Drivers: High prevalence of GHD, growing awareness, and innovations in long-acting hGH drugs.
• Challenges: High cost of treatment, emergence of biosimilars, and complex delivery systems.

FAQs

Q: What is the projected market size for the global Human Growth Hormone (hGH) drugs market by 2030? A: The global hGH drugs market is projected to reach $4.8 billion by 2030[1].

Q: Which route of administration dominates the hGH drugs market? A: The subcutaneous route dominates the hGH drugs market, with a projected CAGR of 4.5% over the analysis period[1].

Q: What are the primary applications of Humatrope? A: Humatrope is used to treat growth hormone deficiency (GHD) in children and adults, Turner syndrome, idiopathic short stature, and Prader-Willi syndrome[1][3].

Q: How is the emergence of biosimilars affecting the hGH market? A: The emergence of biosimilars could erode revenue growth for branded products but also presents opportunities for companies to develop biosimilar versions of their own products[1].

Q: What are the key geographic markets for Humatrope and other hGH drugs? A: North America and Europe are the dominant regions, with the Asia-Pacific region, particularly China, showing significant growth potential[1].

Cited Sources

1. Global Human Growth Hormone (hGH) Drugs Strategic Market Report - ResearchAndMarkets.com
2. Humacyte Third Quarter 2024 Financial Results and Business Update - Humacyte
3. Growth Hormone Deficiency Market Size, Share & Analysis 2032 - SNS Insider
4. Human Growth Hormone Market Size, Growth, Trends, Report 2032 - Market Research Future
5. Humacyte Second Quarter 2024 Financial Results and Business Update - BioSpace