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
Martin Blomberg Jensen	PHASE2
Yunfeng Xia	PHASE2

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
Cyprus	1114000
Hungary	9601721
Germany	69821872
Finland	120291
Brazil	9813463

Market Dynamics and Financial Outlook for Parathyroid Hormone Biologics

Overview
Parathyroid hormone (PTH) biologics primarily include products such as Natpara (recombinant human PTH 1-34) used to treat osteoporosis and hypoparathyroidism. The market is shaped by clinical needs, regulatory environments, and competitive landscape. Revenue estimates for PTH biologics are expected to grow modestly through 2027, driven by emerging indications and increasing diagnosis rates.

Market Size and Revenue Projections

• Global demand for PTH therapies was valued at approximately $400 million in 2022.
• Compound annual growth rate (CAGR) from 2023 to 2027 projected at 4.5%.
• Anticipated market value by 2027 exceeds $500 million, influenced by new indications and broader patient access.

Key Segments

• Osteoporosis management in postmenopausal women.
• Hypoparathyroidism, especially chronic cases.
• Off-label applications, including fracture healing and other endocrine disorders.

Drivers and Restraints
Drivers:

• Rising prevalence of osteoporosis, notably in aging populations—worldwide, over 200 million individuals affected as of 2022 [1].
• Limited treatment options for hypoparathyroidism.
• Advances in delivery methods, such as daily injections and potential long-acting formulations.

Restraints:

• High treatment costs, with annual therapy expenses exceeding $37,000 per patient [2].
• Stringent regulatory approval processes, including the recent FDA approval of Natpara in 2015.
• Safety concerns related to hypercalcemia and potential malignancy risks, affecting clinical adoption.

Regulatory Environment

• FDA approval granted for Natpara in 2015 for hypoparathyroidism.
• European Medicines Agency (EMA) approved the same year; some markets are still under review or lack reimbursement schemes.
• Orphan drug designation applies, offering market exclusivity until at least 2025 in the US.

Competitive Landscape

• Existing Products:

  • Natpara (Lupin) dominates the PTH biologic market.
  • Some biosimilar development, though no biosimilar PTH drugs have reached markets as of 2022.

• Pipeline Candidates:

  • Recombinant PTH analogs in late-stage clinical trials targeting osteoporosis.
  • Long-acting PTH formulations or hybrid delivery systems.

Financial Trajectory for Manufacturers

• Lupin reported Natpara sales of approximately $115 million in 2022.
• Pricing per dose averages $1,200–$2,000, with a typical patient receiving daily injections.
• Sales growth expected at 3–5% annually, impacted by competition and reimbursement policies.

Challenges to Growth

• Patent expirations related to Natpara, expected around 2027.
• Entry of biosimilars may reduce prices and revenues.
• Limited patient pool due to disease rarity unless expanded indications develop.

Emerging Trends

• Development of once-weekly or monthly PTH analogs.
• Gene therapy approaches for long-term management.
• Broader adoption for osteoporosis, currently limited due to cost and regulatory approval barriers.

Conclusion
Growth in PTH biologics hinges on expanding indications, improving delivery methods, and managing costs. The market remains niche but unevenly poised for modest expansion driven by unmet clinical needs and ongoing pipeline development. Patent expiration and biosimilar entry represent key risks that could reshape the financial landscape.

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Key Takeaways

• The PTH biologic market exceeds $400 million annually, with growth expected to reach over $500 million by 2027.
• Major revenue driver is Natpara, with limited competition but potential biosimilar threat after 2027.
• Challenges include high costs, regulatory hurdles, and safety concerns limiting broader adoption.
• Pipeline innovations aim to extend product longevity and expand indications.
• Patent expiration and biosimilar entry are critical factors influencing future revenue streams.

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FAQs

Last updated: February 16, 2026

1. What are the primary indications for PTH biologics?
   Osteoporosis, hypoparathyroidism, and off-label uses like fracture healing.

2. How much revenue does Natpara generate annually?
   Around $115 million in 2022, with steady but modest growth projected.

3. When is patent expiry for Natpara, and how will it affect the market?
   Patent protection expires around 2027, opening opportunities for biosimilar competition.

4. Are biosimilars expected for PTH biologics?
   No biosimilars available as of 2022, but development is underway following patent expiry.

5. What are the main challenges facing PTH biologic market growth?
   High costs, safety concerns, limited indications, and regulatory hurdles.

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Citations
[1] World Health Organization. Osteoporosis Fact Sheet. 2022.
[2] Healthcare Cost and Utilization Project. National Estimates of Healthcare Costs. 2021.