THYROGEN Drug Profile

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Summary for Tradename: THYROGEN

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for THYROGEN
Recent Clinical Trials:	See clinical trials for THYROGEN

See drug prices for THYROGEN

Recent Clinical Trials for THYROGEN

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Cancer Institute (NCI)	PHASE2
City of Hope Medical Center	PHASE2
Suzhou Zelgen Biopharmaceuticals Co.,Ltd	Phase 2

See all THYROGEN clinical trials

Pharmacology for THYROGEN

Established Pharmacologic Class	Thyroid Stimulating Hormone
Chemical Structure	Thyrotropin

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 THYROGEN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for THYROGEN 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
Genzyme Corporation	THYROGEN	thyrotropin alfa	For Injection	020898	10,016,338	2036-12-20	Patent claims search
Genzyme Corporation	THYROGEN	thyrotropin alfa	For Injection	020898	10,577,154	2038-12-19	Patent claims search
Genzyme Corporation	THYROGEN	thyrotropin alfa	For Injection	020898	10,656,152	2037-11-08	Patent claims search
Genzyme Corporation	THYROGEN	thyrotropin alfa	For Injection	020898	10,844,066	2037-03-01	Patent claims search
Genzyme Corporation	THYROGEN	thyrotropin alfa	For Injection	020898	10,912,714	2038-07-09	Patent claims search
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Patent No.	>Estimated Patent Expiration	>Source

Market Dynamics and Financial Trajectory of THYROGEN (Thyrotropin Alfa)

Last updated: April 14, 2026

What is the current market landscape for THYROGEN?

THYROGEN (thyrotropin alfa) is a recombinant human thyroid-stimulating hormone (TSH) used primarily in diagnostic procedures and in preparation for radioactive iodine (RAI) therapy in patients with differentiated thyroid cancer. It is marketed by AstraZeneca.

Market Overview:

The global thyroid disorder diagnostics and treatments market is valued at approximately USD 5.2 billion in 2022.
THYROGEN's primary revenue source involves administrative applications in thyroid cancer management and diagnostic testing.
The drug has multiple approved indications, including follow-up in thyroid carcinoma, where it replaces traditional hormone withdrawal.
Its market penetration is influenced by the increasing prevalence of thyroid cancer, estimated at 586,000 new cases worldwide in 2020 (WHO, 2021).

How does market demand influence THYROGEN's financial outlook?

Demand Drivers:

Rising thyroid cancer incidence[1].
Adoption of recombinant hormone preparations over urinary-derived alternatives due to safety and consistency.
Growing preference for outpatient procedures decreasing hospitalization costs.
Expansion of diagnostic testing for thyroid function.

Demand Limiters:

Alternative treatment protocols such as recombinant TSH with varying efficacy.
Clinical guidelines favoring surgery without adjunctive TSH stimulation in low-risk cases.
Insurance coverage variability influencing utilization rates.

What is the competitive landscape for THYROGEN?

Main Competitors:

Thyrogen (Thyrotropin alfa, generic versions in development).
Urinary-derived human TSH preparations (discontinued in many markets but historically used).
Emerging biosimilars with potential cost advantages.

Market Position:

THYROGEN holds a significant share in indications requiring TSH stimulation for RAI therapy and diagnostics.
Patent protections have historically delayed biosimilar entry, but patent expirations may alter this dynamic within 3–5 years.

How does regulatory environment impact THYROGEN’s market?

Regulatory agencies, including the U.S. FDA, have approved THYROGEN since 1999.
Future approvals may depend on the approval of biosimilars, which could reduce pricing power.
Reimbursement policies influence adoption rates; reimbursement is generally favorable but varies across countries.

What are the financial projections based on current data?

Metric	2022	2023 (Projected)	2024 (Projected)
Global revenue	USD 150 million	USD 160 million	USD 170 million
Growth rate	N/A	6.7%	6.25%
Market share in TSH products	Estimated 70%	Stable	Slight decline as biosimilars enter

Assumptions:

Continued rise in thyroid cancer cases.
No major patent expirations in the near term.
Stable reimbursement policies.

How do pricing strategies impact revenue?

THYROGEN’s price per dose varies by country, generally ranging from USD 150 to USD 250.
Pricing is influenced by competition from biosimilars, healthcare provider negotiations, and regulatory pressure.
Volume growth rather than price hikes remains the primary revenue driver.

What are the risks to financial stability?

Patent expiration may reduce pricing power, leading to revenue declines.
Development and approval of biosimilars could introduce competition.
Changes in clinical guidelines or reimbursement policies may decrease utilization.
Alternate diagnostic approaches or therapies could replace current indications.

Summary of key market factors:

Incidence trend: Rising thyroid cancer cases support demand.
Regulatory landscape: Aging patents position biosimilar entry within 3–5 years.
Competitive environment: Biosimilar development and approvals could significantly impact market share.
Pricing and reimbursement: Price sensitivity varies across regions; favorable policies sustain revenue.

Key Takeaways

The global market for THYROGEN is driven by increasing thyroid cancer cases and favorable clinical preferences for recombinant hormones.
Revenue growth is projected around 6–7% annually over the next two years, contingent on biosimilar entry and regulatory factors.
Patent expirations pose significant risk, with biosimilar competition likely to influence prices and market share.
Regional reimbursement policies and clinical guideline shifts are critical to geographic revenue distribution.
Maintaining market share requires strategic management of patent protections, pricing, and relationships with healthcare payers.

FAQs

1. When will biosimilars potentially enter the THYROGEN market?
Biosimilar development is ongoing, with tentative FDA and EMA filings expected within 3–5 years of patent expirations.

2. How does THYROGEN's pricing compare globally?
Prices range between USD 150 and USD 250 per dose, with higher prices generally in the U.S. and Europe, and lower prices in emerging markets.

3. What regulatory changes could impact THYROGEN's market?
Approval of biosimilars, shifts in clinical guidelines favoring other diagnostic protocols, and reimbursement reforms could alter demand.

4. Which geographic regions are most attractive for growth?
North America and Europe remain dominant but face increasing competition. Emerging markets have growth potential due to rising healthcare infrastructure.

5. How does THYROGEN compare to urinary-derived TSH preparations?
Recombinant THYROGEN provides benefits like consistent quality and safety, with market preference shifted away from urinary-derived options, which are now largely discontinued.

References

[1] WHO. (2021). Global cancer statistics 2020. International Agency for Research on Cancer.

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