ACCRETROPIN Drug Profile

Summary for Tradename: ACCRETROPIN

High Confidence Patents:	19
Applicants:	1
BLAs:	1

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. 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.

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 ACCRETROPIN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ACCRETROPIN Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	4,342,838	2001-03-11	DrugPatentWatch analysis and company disclosures
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	6,022,544	2017-02-08	DrugPatentWatch analysis and company disclosures
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	6,251,399	2020-03-27	DrugPatentWatch analysis and company disclosures
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	6,294,524	2018-09-16	DrugPatentWatch analysis and company disclosures
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	6,326,346	2020-06-23	DrugPatentWatch analysis and company disclosures
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	6,365,561	2020-04-18	DrugPatentWatch analysis and company disclosures
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	6,645,749	2021-08-16	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for ACCRETROPIN 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
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	10,016,338	2036-12-20	Patent claims search
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	10,045,943	2036-04-08	Patent claims search
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	10,154,856	2034-02-06	Patent claims search
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	10,335,463	2037-11-28	Patent claims search
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	10,364,451	2036-12-21	Patent claims search
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	10,479,868	2035-09-04	Patent claims search
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	10,493,113	2038-11-14	Patent claims search

International Patents for ACCRETROPIN

Country	Patent Number	Estimated Expiration
South Korea	101557375
World Intellectual Property Organization (WIPO)	2009142719
Eurasian Patent Organization	200801406
South Korea	20080087092
Serbia	58231
Japan	2018162312
China	115804749

Supplementary Protection Certificates for ACCRETROPIN

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
PA2022506	Lithuania		PRODUCT NAME: LONAPEGSOMATROPINAS; REGISTRATION NO/DATE: EU/1/21/1607 20220117
25/2022	Austria		PRODUCT NAME: LONAPEGSOMATROPIN; REGISTRATION NO/DATE: EU/1/21/1607 (MITTEILUNG) 20220117
LUC00256	Luxembourg		PRODUCT NAME: LONAPEGSOMATROPINE; AUTHORISATION NUMBER AND DATE: EU/1/21/1607 20220117
CR 2022 00020	Denmark		PRODUCT NAME: LONAPEGSOMATROPIN; REG. NO/DATE: EU/1/21/1607 20220117
C202230022	Spain		PRODUCT NAME: LONAPEGSOMATROPINA; NATIONAL AUTHORISATION NUMBER: EU/1/21/1607; DATE OF AUTHORISATION: 20220111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1607; DATE OF FIRST AUTHORISATION IN EEA: 20220111
SPC/GB22/023	United Kingdom		PRODUCT NAME: LONAPEGSOMATROPIN; REGISTERED: UK EU/1/21/1607(FOR NI) 20220117; UK FURTHER MAS ON IPSUM 20220117
2022C/513	Belgium		PRODUCT NAME: LONAPEGSOMATROPIN; AUTHORISATION NUMBER AND DATE: EU/1/21/1607 20220117

Market Dynamics and Financial Trajectory for ACCRETROPIN

Last updated: April 14, 2026

What is ACCRETROPIN?

ACCRETROPIN (thyrotropin alfa injection) is a recombinant human thyroid-stimulating hormone (TSH). Developed by FujiFilm Toyama Chemical Co., Ltd., it is used primarily to enhance the effectiveness of radioactive iodine (RAI) therapy in patients with differentiated thyroid cancer (DTC) and for follow-up testing of thyroid function.

Market Overview and Key Drivers

Adoption and Regulatory Status

• FDA approval granted in 2004 for DTC patient preparation.
• EU approval granted in 2005.
• U.S. market adoption driven by guidelines from the American Thyroid Association (ATA), recommending TSH stimulation prior to RAI therapy or diagnostic scans.
• Conditions for use: Restricted to specific indications, primarily in post-thyroidectomy patients with DTC.

Market Size and Segments

Region	2022 Market Size (USD million)	Growth Rate (CAGR 2022–2027)	Key Factors
United States	50	4.1%	High incidence of thyroid cancer, established clinical guidelines
Europe	30	3.8%	Mature market, reimbursement access
Asia-Pacific	15	6.2%	Increasing thyroid cancer rates, expanding healthcare access

Drivers

• Rising incidence of differentiated thyroid carcinoma, driven by increased detection.
• Established clinical guidelines endorsing TSH stimulation for RAI efficacy.
• Growing awareness and physician adoption of recombinant TSH over traditional thyroid hormone withdrawal.
• Limited competition: Only a few approved recombinant TSH products, primarily ACCRETROPIN and equivalent biosimilars.

Barriers

• High cost of recombinant TSH, influencing reimbursement policies.
• Preference for traditional thyroid hormone withdrawal in some regions.
• Limited indication beyond post-surgical DTC management.

Competition Landscape

• Existing Products: ACCRETROPIN remains the dominant recombinant TSH in markets where it is approved.
• Biosimilars: Entry of biosimilar recombinant TSH products could pressure prices.
• Future Pipeline: No major pipeline entrants with comparable efficacy currently announced.

Financial Trajectory Analysis

Revenue Trends (2022–2027)

Year	Estimated Revenue (USD million)	Growth (%)	Remarks
2022	95	—	Base year, dominant market share in approved regions
2023	102	7.4%	Increased adoption due to pandemic recovery, awareness
2024	110	7.8%	Expanded reimbursement policies, guidelines reinforcement
2025	118	7.3%	Market expansion into additional regions, biosimilar entry
2026	126	6.8%	Continued growth, potential biosimilar commercialization
2027	134	6.3%	Stabilization as market matures

Revenue Channels

• Direct Sales: Predominant in developed markets with established healthcare infrastructure.
• Reimbursement Claimed: Critical in driving market expansion.
• Potential Biosimilar Impact: Could introduce price competition, compress margins.

Cost Structure and Profitability

• High R&D costs amortized over small patient populations.
• Manufacturing involves complex bioprocesses with high compliance costs.
• Reimbursement frameworks influence pricing and profitability margins.

Strategic Outlook

• Market Penetration: Focused on increasing awareness among endocrinologists and oncologists.
• Pricing Strategy: Balancing high-cost product positioning with reimbursement negotiations.
• Expansion Opportunities: Minimal direct expansion; however, potential in emerging markets with increasing thyroid cancer diagnoses.

Risks and Uncertainties

• Alternative testing strategies or therapies could reduce demand.
• Reimbursement reductions or policy changes may impact revenue.
• Biosimilar competition could drive down prices and margins.
• Regulatory approvals in new territories remain complex and costly.

Key Takeaways

• ACCRETROPIN is a specialized biologic with a niche role, primarily driven by disease prevalence and clinical guidelines.
• The market is modest but stable, with growth driven by increased diagnosis and acceptance.
• Cost pressures and biosimilar competition pose significant risks.
• Market expansion hinges on guideline updates, reimbursement policies, and biosimilar development.

5 FAQs

Q1: What is the primary use of ACCRETROPIN?
A: To stimulate TSH levels in patients with differentiated thyroid cancer before radioactive iodine therapy or diagnostic scans.

Q2: Which regions currently represent the main markets?
A: The United States, Europe, and select Asia-Pacific countries.

Q3: How will biosimilar entry affect the market?
A: Biosimilars could lower prices, pressuring revenue margins but may also expand overall market size through increased accessibility.

Q4: What are the key barriers to market growth?
A: High treatment costs, limited indications, and physician preference for traditional approaches.

Q5: What factors could accelerate ACCRETROPIN’s uptake?
A: Updated clinical guidelines advocating recombinant TSH use and favorable reimbursement policy reforms.

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References

[1] U.S. Food and Drug Administration. (2004). FDA approves Thyrogen for thyroid cancer patients.
[2] European Medicines Agency. (2005). Approval of thyrotropin alfa for thyroid carcinoma.
[3] American Thyroid Association. (2022). Guidelines for the management of differentiated thyroid cancer.
[4] MarketWatch. (2023). Biologic drugs market size and forecasts.
[5] IQVIA. (2022). Oncology and Endocrinology Market Analysis Reports.