Somatropin - Biologic Drug Details

Summary for somatropin

Tradenames:	11
High Confidence Patents:	17
Applicants:	9
BLAs:	10
Suppliers: see list	7
Recent Clinical Trials:	See clinical trials for somatropin
Drug Prices:	Drug price information for somatropin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for somatropin

Recent Clinical Trials for somatropin

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Northwell Health	Phase 3
Beni-Suef University	Phase 2/Phase 3
Ascendis Pharma Endocrinology Division A/S	Phase 2

See all somatropin clinical trials

Recent Litigation for somatropin

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
NOVO NORDISK INC. v. RIO BIOPHARMACEUTICALS, INC.	2024-02-05
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.	2023-01-19
Novo Nordisk, Inc. v. Mylan Pharmaceuticals, Inc.	2022-08-08

See all somatropin litigation

PTAB Litigation

Petitioner	Date
	2017-05-19

See all somatropin litigation

Pharmacology for somatropin

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 somatropin Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for somatropin 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		2013-03-15	Company disclosures
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640		2013-03-15	Company disclosures
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640		2013-03-15	Company disclosures

3) Low Certainty: US Patents for somatropin 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		2033-03-11	Patent claims search
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640		2034-11-02	Patent claims search
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640		2033-02-06	Patent claims search

International Patents for somatropin

Country	Patent Number	Estimated Expiration
Australia	5824301
Hungary	9401832
Japan	2003533288

Supplementary Protection Certificates for somatropin

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SPC008/2003	Ireland		SPC008/2003: 20030508, EXPIRES: 20121217

Market Dynamics and Financial Trajectory for the Biologic Drug: Somatropin

Introduction to Somatropin

Somatropin, a recombinant human growth hormone, is a biologic drug used to treat growth hormone deficiency in children and adults, as well as other conditions such as Turner syndrome and Prader-Willi syndrome. The market for somatropin is driven by several key factors, which are explored in detail below.

Market Size and Growth Rate

The global somatropin market is valued at approximately US$ 3.85 billion as of 2023 and is expected to grow at a compound annual growth rate (CAGR) of 7.3% to 7.38% from 2023 to 2030[1][4].

Key Drivers of the Somatropin Market

Increasing Diagnoses and Medical Diagnostic Technology

The market is driven by the increasing frequency of growth hormone deficiency diagnoses in both adults and children. Advances in medical diagnostic technology enable earlier and more precise identification of growth hormone deficiency, contributing to the growing demand for somatropin[1].

Regulatory Approvals

Product approvals from regulatory authorities such as the U.S. Food and Drug Administration (FDA) are significant drivers. For instance, the FDA approved NGENLA (somatrogon-ghla), a once-weekly human growth hormone analog, in June 2023, which is expected to boost market growth[4].

Long-Term Effects of Growth Hormone Therapy

The long-term benefits of growth hormone therapy, particularly in children with growth hormone deficiency, are another driving factor. These benefits include improved growth rates and overall health outcomes[4].

Regional Market Dynamics

North America

North America dominates the global somatropin market, driven by increased government initiatives for cost-effective treatments and a rising number of pituitary dysfunction cases. The region is also home to a strong clinical pipeline and significant research and drug development activities[1][4].

Europe

Europe is the second major contributor to the global somatropin market. Similar to North America, Europe benefits from government initiatives and a high prevalence of growth hormone-related disorders[1].

Asia Pacific

The Asia Pacific region is expected to grow rapidly, driven by countries such as Japan, India, and China. The region's large population base and improving healthcare infrastructure make it a lucrative market for somatropin[1][5].

Distribution Channels

The global somatropin market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are expected to dominate the market due to the preference and ease of availability of somatropin in these settings[4].

Economic Implications and Cost Analysis

Cost Savings

The use of somatropin can lead to significant cost savings. For example, in the management of short bowel syndrome, somatropin reduces the need for parenteral nutrition, resulting in healthcare cost savings of up to $85,474 over two years[2].

High Treatment Costs

Despite the cost savings, the high expense of receiving somatropin treatment remains a significant barrier. The cost of somatropin treatment can be substantial, which may deter some patients, especially in regions with limited access to health insurance or government-sponsored healthcare programs[1][5].

Challenges and Limitations

Regulatory Hurdles

The development and approval of somatropin therapies involve stringent regulatory processes and clinical trials, which can be time-consuming and costly. These hurdles can delay the introduction of new therapies to the market[5].

Limited Awareness and Diagnosis Challenges

Many cases of growth hormone deficiency, particularly in pediatric patients, remain undiagnosed due to limited awareness and diagnostic challenges. This underdiagnosis can limit the market's growth potential[5].

Impact of COVID-19 Pandemic

The COVID-19 pandemic has had a mixed impact on the somatropin market. While it presented challenges in terms of supply chain disruptions and delayed clinical trials, it also highlighted the importance of robust healthcare systems and the need for effective treatments for chronic conditions[4].

Competitive Landscape

The global somatropin market is competitive, with key players including Pfizer, Novo Nordisk, Eli Lilly and Company, and Sandoz International GmbH. These companies are investing heavily in research and development, product launches, and expanding their manufacturing capacities to meet the growing demand for somatropin[4].

Future Outlook

The somatropin market is poised for significant growth, driven by increasing product approvals, rising prevalence of growth hormone-related disorders, and advancements in medical technology. The Asia Pacific region is expected to be a key growth area due to its large population and improving healthcare infrastructure.

Key Takeaways

• The global somatropin market is expected to grow at a CAGR of 7.3% to 7.38% from 2023 to 2030.
• North America and Europe are the dominant regions, with the Asia Pacific region showing rapid growth.
• Regulatory approvals and the long-term benefits of growth hormone therapy are key drivers.
• High treatment costs and regulatory hurdles are significant challenges.
• The market is expected to benefit from increasing government initiatives and advancements in medical diagnostic technology.

Frequently Asked Questions (FAQs)

Q: What is the current market size of the global somatropin market? A: The global somatropin market was valued at approximately US$ 3.85 billion in 2023[4].

Q: What is the expected CAGR of the global somatropin market from 2023 to 2030? A: The global somatropin market is expected to grow at a CAGR of 7.3% to 7.38% from 2023 to 2030[1][4].

Q: Which regions dominate the global somatropin market? A: North America and Europe are the dominant regions, with the Asia Pacific region showing rapid growth[1][4].

Q: What are the key drivers of the somatropin market? A: Key drivers include increasing diagnoses of growth hormone deficiency, regulatory approvals, and the long-term benefits of growth hormone therapy[1][4].

Q: What are the major challenges facing the somatropin market? A: High treatment costs, regulatory hurdles, and limited awareness and diagnosis challenges are significant barriers[1][5].

Cited Sources:

1. InsightAce Analytic - Somatropin Market Share, Size, Growth and Forecast to 2031[1]
2. PubMed - Economic implications of growth hormone use in patients with short bowel syndrome[2]
3. Maximize Market Research - Biosimilar Market: Global Industry Analysis and Forecast (2024-2030)[3]
4. Coherent Market Insights - Somatropin Market - Share, Size and Industry Analysis[4]
5. TechSci Research - Pediatric Growth Hormone Deficiency Market Size and Forecast 2028[5]