Parathyroid hormone - Biologic Drug Details

Summary for parathyroid hormone

Tradenames:	1
High Confidence Patents:	1
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for parathyroid hormone

Recent Clinical Trials for parathyroid hormone

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE2
Yunfeng Xia	PHASE2
Alebund Pharmaceuticals	PHASE3

See all parathyroid hormone clinical trials

Pharmacology for parathyroid hormone

Established Pharmacologic Class	Parathyroid Hormone
Chemical Structure	Parathyroid 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. DrugPatentWatch analysis and 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 parathyroid hormone Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for parathyroid hormone 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
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511		1995-04-25	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511		2013-12-23	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511		2026-10-02	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for parathyroid hormone 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
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511		2036-01-08	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511		2036-12-20	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511		2036-09-22	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511		2035-05-08	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511		2038-02-02	Patent claims search

International Patents for parathyroid hormone

Country	Patent Number	Estimated Expiration
China	1142772
Czech Republic	184296
China	1116897
Eurasian Patent Organization	004761
Australia	1717799

Market Dynamics and Financial Trajectory for the Biologic Drug: Parathyroid Hormone

Last updated: July 30, 2025

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Introduction

Parathyroid hormone (PTH) therapies, primarily represented by Forteo (teriparatide), have established a critical niche within the osteoporosis treatment landscape. As a recombinant analog of the naturally occurring hormone, PTH plays a pivotal role in calcium regulation and bone metabolism. This article examines the evolving market dynamics and financial trajectories of PTH-based biologics, contextualizing their positioning amid emerging therapies and shifting healthcare paradigms.

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Market Overview

Therapeutic Indications and Current Market Share

PTH analogs primarily target osteoporosis in postmenopausal women and men at high fracture risk. Teriparatide, approved by the FDA in 2002, marked a significant advancement over traditional bisphosphonates due to its anabolic mechanism. However, its market penetration remains constrained compared to bisphosphonates, owing to factors including administration route (daily subcutaneous injections), cost, and safety concerns such as osteosarcoma risk observed in animal studies [1].

Market Size and Growth Drivers

The global osteoporosis market was valued at approximately USD 10 billion in 2022, with biologic interventions representing a growing segment. The anabolic class, including PTH analogs, is projected to grow at a CAGR of 5-7% over the next five years, driven by increased aging populations, rising awareness of fracture risks, and advancements in biologic manufacturing.

Key growth drivers include:

• Aging Demographics: The increasing prevalence of osteoporosis among the elderly populations in North America, Europe, and Asia-Pacific.
• Prescriptive Shift: Growing preference for anabolic treatments as first-line therapy in specific high-risk groups.
• Healthcare Policy Trends: Emphasis on fracture prevention reduces long-term treatment costs, incentivizing the adoption of effective therapies like PTH.

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Market Challenges and Competitive Landscape

Pricing and Reimbursement Constraints

Despite clinical benefits, PTH therapies often face reimbursement hurdles owing to their high costs (approximately USD 1,700 for a monthly injection in the U.S.) and safety concerns [2]. Payers favor generic and less expensive bisphosphonates, limiting the growth potential of PTH biologics.

Safety and Duration Limitations

FDA recommends a maximum of two years of PTH therapy, necessitating transition to antiresorptive agents afterward. These restrictions impact long-term usage, with consequent effects on sales volumes.

Emerging Competitors and Alternative Therapies

Novel anabolic agents, notably abaloparatide (an investigational PTH analog) and romosozumab (a monoclonal antibody stimulating bone formation), threaten PTH's market share. Additionally, oral therapies such as odN increased, combined with diagnostic advancements, promote earlier diagnosis and prompt treatment interventions.

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Innovations and Pipeline Developments

Next-Generation PTH Analogues

Pharmaceutical companies are investing in next-generation PTH molecules with improved safety profiles, extended dosing intervals, and enhanced efficacy. For instance, long-acting PTH formulations aim to reduce injection frequency, potentially improving adherence and patient outcomes.

Gene and Cell Therapies

Emerging research explores gene therapy approaches to modulate PTH levels or mimic its activity, promising revolutionary shifts in osteoporosis management.

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Financial Trajectory and Investment Outlook

Revenue Projections

Forteo’s US sales peaked around USD 600 million in 2010, but have since plateaued or declined, partly due to market saturation and safety restrictions. The global PTH market revenue is expected to grow modestly, reaching approximately USD 2 billion by 2028, driven by emerging markets and incremental adoption of new formulations [3].

R&D and Capital Expenditure

Pharmaceutical firms continue to allocate substantial R&D budgets toward innovative PTH-based therapies, with 2020-2022 R&D investments exceeding USD 200 million annually by key players like Eli Lilly (Forteo’s manufacturer) and novel entrants.

Mergers, Acquisitions, and Strategic Alliances

Strategic collaborations aim to expand formulations, improve delivery systems, and extend patents, preserving market competitiveness. The M&A landscape reflects consolidation tendencies, with larger firms acquiring smaller biotech entities developing next-gen biologics.

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Regulatory and Market Access Considerations

Recent FDA reviews emphasize post-marketing safety data, potentially influencing prescribing guidelines and reimbursement policies. Countries with healthcare systems emphasizing value-based care may impose stricter criteria for PTH therapy reimbursement, influencing overall financial trajectories.

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Future Outlook and Strategic Implications

While PTH's current market is constrained by safety, cost, and administration routes, ongoing innovations and expanding indications could revitalize its growth. Personalized therapy approaches, leveraging biomarkers for fracture risk, and combination regimens with antiresorptives may enhance PTH’s market appeal.

Investors and stakeholders should monitor clinical trial pipelines, safety profile updates, and evolving reimbursement policies that significantly influence the biological's financial trajectory. The integration of digital health tools to improve adherence and real-world evidence generation is also critical for future success.

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Key Takeaways

• The global PTH biologics market is projected to grow modestly, reaching USD 2 billion by 2028, driven by demographic trends and therapeutic innovations.
• Safety restrictions, high costs, and administration challenges currently limit PTH's market penetration.
• Emerging therapies and next-generation formulations are poised to address current limitations, offering potential growth catalysts.
• Strategic focus on safety, cost-effectiveness, and personalized medicine will be pivotal for market expansion.
• Public health policies and reimbursement frameworks heavily influence sales trajectories and investment opportunities.

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FAQs

1. What are the main factors limiting the growth of PTH-based biologics?
Safety concerns (notably osteosarcoma risk), high treatment costs, administration complexity, and regulatory restrictions on duration limit market expansion.

2. How does the competition from alternative osteoporosis therapies affect PTH’s market?
Oral treatments, newer anabolic agents like romosozumab, and bisphosphonates with favorable cost and safety profiles challenge PTH’s market share.

3. Are there promising pipeline drugs that could transform PTH therapy?
Yes. Long-acting PTH analogs and gene therapies in development aim to improve safety, efficacy, and patient adherence.

4. How do reimbursement policies impact the financial prospects of PTH biologics?
Stringent reimbursement criteria and cost-containment measures can restrict access, limiting revenue growth despite clinical demand.

5. What strategic moves can pharma companies adopt to enhance PTH therapies’ market position?
Investing in innovative formulations, expanding indications, leveraging digital health tools, and engaging with payers on value-based pricing models are critical.

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References

[1] National Osteoporosis Foundation, "Osteoporosis Treatment Overview," 2022.
[2] U.S. Food and Drug Administration, "Forteo (teriparatide) Prescribing Information," 2022.
[3] MarketWatch, "Global Osteoporosis Drugs Market Forecast," 2023.