Denosumab - Biologic Drug Details

Summary for denosumab

Tradenames:	2
High Confidence Patents:	10
Applicants:	2
BLAs:	2
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for denosumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for denosumab

Recent Clinical Trials for denosumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Wuhan Union Hospital, China	Phase 3
Peking Union Medical College Hospital	N/A
Washington University School of Medicine	Phase 1/Phase 2

See all denosumab clinical trials

Recent Litigation for denosumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.	2018-04-30

See all denosumab litigation

Pharmacology for denosumab

Mechanism of Action	RANK Ligand Blocking Activity
Established Pharmacologic Class	RANK Ligand Inhibitor

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 denosumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for denosumab Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	PROLIA	denosumab	Injection	125320		2016-12-23	Company disclosures
Amgen Inc.	PROLIA	denosumab	Injection	125320		2017-04-16	Company disclosures
Amgen Inc.	PROLIA	denosumab	Injection	125320		2021-06-26	Company disclosures
Amgen Inc.	PROLIA	denosumab	Injection	125320		2016-12-23	Company disclosures
Amgen Inc.	PROLIA	denosumab	Injection	125320		2016-12-23	Company disclosures
Amgen Inc.	PROLIA	denosumab	Injection	125320		2017-04-16	Company disclosures

3) Low Certainty: US Patents for denosumab 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
Amgen Inc.	PROLIA	denosumab	Injection	125320		2039-02-26	Patent claims search
Amgen Inc.	PROLIA	denosumab	Injection	125320		2033-03-11	Patent claims search
Amgen Inc.	PROLIA	denosumab	Injection	125320		2030-10-06	Patent claims search
Amgen Inc.	PROLIA	denosumab	Injection	125320		2032-10-22	Patent claims search
Amgen Inc.	PROLIA	denosumab	Injection	125320		2034-07-17	Patent claims search
Amgen Inc.	PROLIA	denosumab	Injection	125320		2022-03-20	Patent claims search

International Patents for denosumab

Country	Patent Number	Estimated Expiration
Bulgaria	65242
China	103990122
European Patent Office	2371962
Japan	2022000424
Japan	2002514418
Romania	128635

Supplementary Protection Certificates for denosumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 44/2010	Austria		PRODUCT NAME: DENOSUMAB
122010000048	Germany		PRODUCT NAME: DENOSUMAB; REGISTRATION NO/DATE: EU/1/10/618/001-004 20100526
132010901893988	Italy		PRODUCT NAME: DENOSUMAB(PROLIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/10/618/001-004, 20100526
300465	Netherlands		PRODUCT NAME: DENOSUMAB; REGISTRATION NO/DATE: EU/1/10/618/001-004 20100528
C300465	Netherlands		PRODUCT NAME: DENOSUMAB; REGISTRATION NO/DATE: EU/1/10/618/001-004 20100526
C201000038	Spain		PRODUCT NAME: DENOSUMAB; NATIONAL AUTHORISATION NUMBER: EU/1/10/618/001-004; DATE OF AUTHORISATION: 20100526; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/10/618/001-004; DATE OF FIRST AUTHORISATION IN EEA: 20100526

Market Dynamics and Financial Trajectory of Denosumab

Introduction to Denosumab

Denosumab, a human monoclonal antibody, is a pivotal drug in the treatment of various bone-related conditions, including osteoporosis and bone metastases. It is marketed under the brand names Prolia and Xgeva, depending on the indication.

Current Market Size and Growth

The denosumab market has experienced significant growth in recent years. As of 2023, the market size was $2.89 billion, which surged to $3.27 billion in 2024, reflecting a compound annual growth rate (CAGR) of 13.2%[1][3][4].

Historical Growth Drivers

Several factors have contributed to the rapid growth of the denosumab market in the historical period:

• Advancements in Clinical Trials and Research: Continuous improvements in clinical trials and research have enhanced the efficacy and safety profile of denosumab.
• FDA Approvals and Regulatory Milestones: Key regulatory approvals have expanded the indications for denosumab, increasing its market reach.
• Growing Awareness of Bone Health: Increased awareness about bone health among patients and healthcare providers has driven demand for denosumab.
• Strategic Partnerships and Marketing Initiatives: Collaborations and targeted marketing efforts have played a crucial role in promoting the drug and expanding its user base[1][3][4].

Future Growth Projections

The denosumab market is anticipated to continue its strong growth trajectory. Here are the key projections and drivers:

• Projected Market Size: The market is expected to reach $5.06 billion by 2028, with a CAGR of 11.5%[1][3][4].
• Rising Incidence of Bone Metastases: The increasing incidence of bone metastases, particularly in cancer patients, will drive the demand for denosumab.
• Advancements in Cancer Therapies: Improvements in cancer treatments and the integration of denosumab into these therapies will further boost the market.
• Osteoporosis Prevalence: The growing prevalence of osteoporosis, especially among the aging population, will contribute significantly to the market growth.
• Increased Awareness of Osteoporosis: Greater awareness and diagnosis of osteoporosis will lead to higher adoption rates of denosumab.
• Regulatory Approvals for New Indications: Expected approvals for new indications will expand the market potential of denosumab[1][3][4].

Market Segmentation

The denosumab market can be segmented in several ways:

• By Drug Classification: Prolia and Xgeva are the primary classifications, with other formulations also available[3].
• By Type: Denosumab is available in 60 mg and 120 mg doses[3].
• By End-Users: The market is segmented into hospitals, homecare, specialty clinics, and ambulatory surgical centers[3].

Key Trends

Several trends are shaping the future of the denosumab market:

• Strategic Collaborations and Partnerships: Companies are engaging in strategic collaborations to enhance research, development, and marketing efforts.
• Integration with Digital Health Solutions: The integration of denosumab treatment with digital health solutions is expected to improve patient outcomes and adherence.
• Expanded Indications and Clinical Applications: Ongoing research is likely to expand the indications for denosumab, further increasing its market potential.
• Advancements in Biosimilar Development: The development of biosimilars could provide more affordable alternatives, although this may also introduce competition to the original drug[3][4].

Safety and Efficacy Considerations

While denosumab has shown significant efficacy, it also comes with several safety considerations:

• Cardiovascular Risks: Denosumab may increase the risk of myocardial infarction, stroke, and cardiovascular death, particularly in patients with pre-existing cardiovascular conditions[2].
• Hypocalcemia: Patients with advanced chronic kidney disease are at a higher risk of severe hypocalcemia following denosumab administration[2].
• Osteonecrosis of the Jaw (ONJ): ONJ is a potential side effect, especially in patients undergoing tooth extraction or with local infections[2].
• Serious Infections: Denosumab treatment has been associated with a higher incidence of serious infections, including skin, abdominal, urinary tract, and ear infections[2][5].

Financial Support and Access Programs

To make denosumab more accessible, several support programs are available:

• Amgen SupportPlus Co-Pay Program: This program helps eligible commercially insured patients lower their out-of-pocket prescription costs for Prolia[2].
• Access and Fulfillment Pathways: Multiple pathways are available to help patients access Prolia, ensuring that those at high risk for fractures can receive the necessary treatment[5].

Conclusion

The denosumab market is poised for continued robust growth, driven by a combination of clinical advancements, regulatory approvals, and increasing awareness of bone health. While the drug offers significant benefits, it is crucial to monitor and manage its associated risks.

Key Takeaways

• The denosumab market grew from $2.89 billion in 2023 to $3.27 billion in 2024.
• The market is projected to reach $5.06 billion by 2028 with a CAGR of 11.5%.
• Key growth drivers include rising incidence of bone metastases, advancements in cancer therapies, and increased awareness of osteoporosis.
• Denosumab is available under different classifications and types, catering to various end-users.
• Safety considerations include cardiovascular risks, hypocalcemia, ONJ, and serious infections.

FAQs

What is denosumab used for?

Denosumab is used to treat various bone-related conditions, including osteoporosis and bone metastases. It is marketed under the brand names Prolia and Xgeva.

What are the key growth drivers for the denosumab market?

The key growth drivers include advancements in clinical trials and research, FDA approvals, growing awareness of bone health, strategic partnerships, and rising incidence of bone metastases and osteoporosis.

What are the potential risks associated with denosumab?

Potential risks include cardiovascular events, severe hypocalcemia, osteonecrosis of the jaw (ONJ), and serious infections.

How is denosumab segmented in the market?

The market is segmented by drug classification (Prolia and Xgeva), type (60 mg and 120 mg doses), and end-users (hospitals, homecare, specialty clinics, and ambulatory surgical centers).

Are there any financial support programs available for denosumab?

Yes, programs like the Amgen SupportPlus Co-Pay Program help eligible patients lower their out-of-pocket costs for Prolia.

Sources

1. The Business Research Company - Global Denosumab Market Insights 2024, Forecast To 2033
2. Amgen - Amgen SupportPlus Co-Pay Program for Prolia (denosumab)
3. The Business Research Company - Global Denosumab Market Report 2024
4. EIN Presswire - Denosumab Market Size, Share, Revenue, Trends And Drivers for 2024-2033
5. Amgen - Support and Access | Prolia (denosumab)