XGEVA Drug Profile

Summary for Tradename: XGEVA

High Confidence Patents:	0
Applicants:	1
BLAs:	1

Pharmacology for XGEVA

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 XGEVA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for XGEVA 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.	XGEVA	denosumab	Injection	125320			Company disclosures
Amgen Inc.	XGEVA	denosumab	Injection	125320		2016-12-23	Company disclosures
Amgen Inc.	XGEVA	denosumab	Injection	125320		2017-04-16	Company disclosures
Amgen Inc.	XGEVA	denosumab	Injection	125320		2021-06-26	Company disclosures
Amgen Inc.	XGEVA	denosumab	Injection	125320		2016-12-23	Company disclosures
Amgen Inc.	XGEVA	denosumab	Injection	125320		2016-12-23	Company disclosures

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

International Patents for XGEVA

Country	Patent Number	Estimated Expiration
Australia	779461
China	103990122
Australia	5618098
Montenegro	P32808
Eurasian Patent Organization	003636
Taiwan	I326285

Supplementary Protection Certificates for XGEVA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
10C0050	France		PRODUCT NAME: DENOSUMAB; REGISTRATION NO/DATE: EU/1/10/618/001-004 20100528
C00951551/01	Switzerland		PRODUCT NAME: DENOSUMABUM; REGISTRATION NO/DATE: SWISSMEDIC 60210 03.08.2010
1090039-7.L	Sweden		PRODUCT NAME: DENOSUMAB; REG. NO/DATE: EU/1/10/618/001 20100526
2010C/039	Belgium		PRODUCT NAME: DENOSUMAB; AUTHORISATION NUMBER AND DATE: EU/1/10/618/001 20100528
SPC/GB10/043	United Kingdom		PRODUCT NAME: DENOSUMAB, IMMUNOGLOBULIN G2, ANTI-(HUMAN TUMOR NECROSIS FACTOR LIGAND SUPERFAMILY MEMBER 11 (HUMAN OSTEOCLAST DIFFERENTIATION FACTOR))(HUMAN MONOCLONAL AMG 162 HEAVY CHAIN), DISULPHIDE WITH HUMAN MONOCLONAL AMG 162 LIGHT CHAIN, DIMER.; REGISTERED: UK EU/1/10/618/001 20100526; UK EU/1/10/618/002 20100526; UK EU/1/10/618/003 20100526; UK EU/1/10/618/004 20100526
2010C/037	Belgium		PRODUCT NAME: DENOSUMAB; AUTHORISATION NUMBER AND DATE: EU/1/10/618/001

XGEVA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: XGEVA

Introduction

XGEVA, developed by Amgen, is a biologic drug that has made significant strides in the treatment of bone-related conditions, particularly in the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. Here, we delve into the market dynamics and financial trajectory of XGEVA, highlighting its performance, competition, and future outlook.

Approval and Indications

XGEVA, with the active ingredient denosumab, received FDA approval in November 2010 for the prevention of SREs in patients with bone metastases from solid tumors. It is also approved for other indications, including the treatment of giant cell tumor of bone and hypercalcemia of malignancy[4].

Market Position

XGEVA has established itself as a leading drug in its class. A study by ITG Healthcare Market Research indicated that U.S. oncologists expect XGEVA to become the top-prescribed drug for preventing SREs in prostate cancer patients, with significant penetration in the market for breast and lung cancer patients as well[4].

Sales Performance

XGEVA has shown robust sales growth over the years. In the first quarter of 2024, XGEVA sales increased by 5% year-over-year to $561 million, primarily driven by volume growth outside the U.S.[2]. For the full year 2023, XGEVA sales climbed 6%, contributing to Amgen's overall revenue growth[3].

Competitive Landscape

XGEVA competes with other drugs in the SRE prevention market, notably Novartis' Zometa (zoledronic acid). However, XGEVA's subcutaneous route of administration and convenient dosing have made it a preferred choice among physicians. Despite Zometa's dominant position, XGEVA's market share is expected to grow significantly[4].

Biosimilar Competition

The landscape is set to change with the emergence of biosimilar candidates. Several companies, including Sandoz and Celltrion, are in various stages of developing denosumab biosimilars. These biosimilars could potentially challenge XGEVA's market share, especially if they achieve interchangeable status, allowing pharmacists to substitute them for the original product[1].

Financial Impact

The financial performance of XGEVA is integral to Amgen's overall revenue. In 2023, Amgen reported total revenues of $28.2 billion, with XGEVA contributing significantly to this figure. The company's non-GAAP earnings per share rose 5% to $18.65, partly due to the strong performance of XGEVA and other key products[3].

Global Reach

XGEVA is marketed in many countries worldwide. The drug's global presence is a key factor in its financial success, with product sales outside the U.S. showing strong growth, particularly in the Asia-Pacific region[3].

Physician and Patient Preferences

Physicians appreciate XGEVA's increased efficacy and convenient dosing. Despite concerns about its relatively high cost and risks associated with osteonecrosis of the jaw, physicians are enthusiastic about its benefits and plan to initiate more patients on XGEVA as a first-line therapy[4].

Future Outlook

The future outlook for XGEVA remains positive despite the looming threat of biosimilars. Amgen's strong pipeline and ongoing research efforts position the company well for continued growth. The FDA is scheduled to review several of Amgen's pipeline products, which could further bolster the company's financial trajectory[3].

Challenges and Opportunities

One of the significant challenges XGEVA faces is the high cost, which can be a barrier for some patients. However, the drug's efficacy and convenience have helped it maintain a strong market position. The emergence of biosimilars presents both a challenge and an opportunity for Amgen to adapt and innovate in the market.

Cost Considerations

XGEVA is administered via injection, which, although preferred by some for its efficacy, is more expensive than oral alternatives like Fosamax. The list price of XGEVA is approximately $3,400 per injection, administered once every 4 weeks, making it a costly treatment option[1].

Reimbursement Climate

The reimbursement climate is crucial for the adoption of XGEVA. Studies have shown that despite its high cost, XGEVA's benefits are recognized by managed care organizations, which often cover the drug due to its efficacy in preventing SREs[4].

Key Takeaways

• Strong Market Position: XGEVA is a leading drug in preventing SREs in cancer patients.
• Robust Sales Growth: XGEVA has consistently shown year-over-year sales growth.
• Global Reach: The drug is marketed in many countries, contributing to its financial success.
• Biosimilar Competition: Emerging biosimilars could challenge XGEVA's market share.
• High Cost: Despite its efficacy, XGEVA's high cost is a significant factor in its adoption.
• Future Outlook: Amgen's strong pipeline and research efforts position XGEVA for continued growth.

FAQs

What is XGEVA used for?

XGEVA is used primarily for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. It is also approved for other indications such as giant cell tumor of bone and hypercalcemia of malignancy[4].

How does XGEVA compare to other drugs in its class?

XGEVA has gained significant market share due to its subcutaneous route of administration and convenient dosing, making it a preferred choice over competitors like Zometa (zoledronic acid)[4].

What is the impact of biosimilars on XGEVA?

Biosimilar candidates, such as those from Sandoz and Celltrion, could potentially challenge XGEVA's market share, especially if they achieve interchangeable status. However, this also presents an opportunity for Amgen to innovate and adapt[1].

How expensive is XGEVA?

XGEVA is administered via injection and has a list price of approximately $3,400 per injection, administered once every 4 weeks, making it a costly treatment option[1].

What is the future outlook for XGEVA?

Despite the emergence of biosimilars, XGEVA's future outlook remains positive due to Amgen's strong pipeline and ongoing research efforts. The company is well-positioned for continued growth through the end of the decade and beyond[3].

Sources

1. Managed Healthcare Executive: "Prolia and Xgeva Biosimilar Companies Are Queuing Up"
2. PR Newswire: "AMGEN REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS"
3. Amgen Investors: "SHAREHOLDERS 2023"
4. FiercePharma: "ITG Healthcare Market Research Study Finds XGEVA on Track to Be Top-Prescribed Drug for Prevention of SREs in Cancer Patients"