PROLIA Drug Profile

Summary for Tradename: PROLIA

High Confidence Patents:	10
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for PROLIA
Recent Clinical Trials:	See clinical trials for PROLIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROLIA

See drug prices for PROLIA

Recent Clinical Trials for PROLIA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Aristotle University Of Thessaloniki	Phase 4
Alvotech Swiss AG	Phase 3
mAbxience S.A	Phase 3

See all PROLIA clinical trials

Recent Litigation for PROLIA

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 PROLIA litigation

Pharmacology for PROLIA

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 PROLIA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for PROLIA 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	6,740,522	2016-12-23	Company disclosures
Amgen Inc.	PROLIA	denosumab	Injection	125320	7,097,834	2017-04-16	Company disclosures
Amgen Inc.	PROLIA	denosumab	Injection	125320	7,364,736	2021-06-26	Company disclosures
Amgen Inc.	PROLIA	denosumab	Injection	125320	7,411,050	2016-12-23	Company disclosures
Amgen Inc.	PROLIA	denosumab	Injection	125320	7,744,886	2016-12-23	Company disclosures
Amgen Inc.	PROLIA	denosumab	Injection	125320	7,923,008	2017-04-16	Company disclosures

3) Low Certainty: US Patents for PROLIA 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	10,006,091	2039-02-26	Patent claims search
Amgen Inc.	PROLIA	denosumab	Injection	125320	10,016,338	2033-03-11	Patent claims search
Amgen Inc.	PROLIA	denosumab	Injection	125320	10,047,398	2030-10-06	Patent claims search
Amgen Inc.	PROLIA	denosumab	Injection	125320	10,058,630	2032-10-22	Patent claims search
Amgen Inc.	PROLIA	denosumab	Injection	125320	10,065,934	2034-07-17	Patent claims search
Amgen Inc.	PROLIA	denosumab	Injection	125320	10,092,542	2022-03-20	Patent claims search

International Patents for PROLIA

Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	200400063
Germany	951551
Japan	4212470
Norway	20190456
Spain	2144386
Taiwan	200630107

Supplementary Protection Certificates for PROLIA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
46/2010	Austria		PRODUCT NAME: DENOSUMAB; REGISTRATION NO/DATE: EU/1/10/618/001-004 20100526
SZ 44/2010	Austria		PRODUCT NAME: DENOSUMAB
C201000039	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
1090038-9.L	Sweden		PRODUCT NAME: DENOSUMAB; REG. NO/DATE: EU/1/10/618/001 20100526
C01409016/01	Switzerland		PRODUCT NAME: DENOSUMABUM; SWISSMEDIC-GESUCH 61865 12.07.2010; MAXIMALE LAUFZEIT: 02.02.2026
SPC/GB10/045	United Kingdom		PRODUCT NAME: DENOSUMAB, IMMUNOGLOBULIN G2, ANTI-(HUMAN TUMOR NECROSIS FACTOR LIGAND SUPERFAMILY MEMBER 11 (HUMAN OSTEOCLAST DIFFERENTIATION FACTOR)) (HUMAN MONOCLONAL AMG162 HEAVY CHAIN), DISULPHIDE WITH HUMAN MONOCLONAL AMG162 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

Market Dynamics and Financial Trajectory for Prolia

Introduction to Prolia

Prolia, a brand name for the drug denosumab, is a monoclonal antibody used primarily to treat osteoporosis and other bone-related disorders. It is manufactured by Amgen and has been a significant player in the pharmaceutical market.

Market Size and Growth

The global denosumab market, which includes Prolia, has shown robust growth. In 2022, the market size was valued at USD 2,892.17 million, and it is projected to reach USD 7,109.92 million by 2030, with a Compound Annual Growth Rate (CAGR) of 11.9% during the forecast period from 2023 to 2030[1].

Drivers of Market Growth

Several factors are driving the growth of the Prolia market:

Increasing Prevalence of Osteoporosis

As the global population ages, the prevalence of osteoporosis is expected to rise, leading to an increased demand for medications like Prolia that help prevent fractures and improve bone health[1].

Growing Awareness and Diagnosis

Increased awareness about osteoporosis and its impact on overall health has led more individuals to seek diagnosis and treatment, contributing to the demand for Prolia[1].

Efficacy and Safety Profile

Prolia's efficacy and safety profile, particularly for expanded indications, have further bolstered its market position. The drug's ability to treat various bone-related disorders effectively has made it a preferred choice among healthcare providers[1].

Financial Performance

Prolia has consistently demonstrated strong financial performance:

Sales Growth

In the second quarter of 2024, Prolia sales grew 13% to $1.2 billion, reflecting its continued market dominance[2]. For the full year 2022, Prolia sales increased 12% year-over-year to a record $992 million in the fourth quarter and $3.628 billion for the full year, primarily driven by volume growth[4].

Revenue Contribution

Prolia is one of Amgen's top-selling drugs, significantly contributing to the company's total revenues. In 2022, Prolia sales accounted for a substantial portion of Amgen's total product sales, which were $6,552 million[4].

Market Segmentation

The global denosumab market, including Prolia, is segmented based on:

Drug Classification

• Prolia: Dominates the drug classification segment due to its high demand for treating bone-related disorders.
• Xgeva: Another denosumab product by Amgen, used for different indications.
• Others: Includes other denosumab products and biosimilars[1].

End-Users

• Hospitals
• Homecare
• Specialty Clinics
• Ambulatory Surgical Centers
• Others

Distribution Channel

• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacy[1].

Competitive Landscape

While Prolia remains a market leader, it is facing increasing competition from biosimilar candidates:

Biosimilar Threats

Several pharmaceutical companies, including Celltrion, Samsung Bioepis/Biogen, Teva, Fresenius Kabi, and Gedeon Richter, are in various stages of developing denosumab biosimilars. This competition could potentially impact Prolia's market share in the future[3].

Future Outlook

Despite the looming competition from biosimilars, Amgen remains confident in Prolia's continued growth. The company has been investing heavily in research and development, aiming for future breakthroughs in other therapeutic areas. This strategic approach is expected to help Amgen maintain its market position and drive further growth[5].

Key Takeaways

• Robust Market Growth: The global denosumab market, driven by Prolia, is expected to grow significantly, reaching USD 7,109.92 million by 2030.
• Strong Financial Performance: Prolia has consistently shown strong sales growth, contributing substantially to Amgen's revenues.
• Increasing Competition: The market is set to face competition from biosimilar candidates, which could impact Prolia's market share.
• Future Investments: Amgen's continued investment in research and development aims to secure future growth and innovation.

Frequently Asked Questions (FAQs)

Q1: What is Prolia used for? Prolia, or denosumab, is primarily used to treat osteoporosis and other bone-related disorders by preventing fractures and improving bone health.

Q2: How is the global denosumab market expected to grow? The global denosumab market is projected to grow from USD 2,892.17 million in 2022 to USD 7,109.92 million by 2030, with a CAGR of 11.9% during the forecast period.

Q3: What are the key drivers of Prolia's market growth? The key drivers include the increasing prevalence of osteoporosis, growing awareness and diagnosis of bone-related disorders, and the efficacy and safety profile of Prolia.

Q4: How has Prolia performed financially? Prolia has shown strong financial performance with sales growth of 13% to $1.2 billion in Q2 2024 and a full-year sales increase of 12% in 2022.

Q5: What is the competitive landscape for Prolia? Prolia faces increasing competition from biosimilar candidates from several pharmaceutical companies, which could impact its market share in the future.

Cited Sources:

1. Data Bridge Market Research - Global Denosumab Market – Industry Trends and Forecast to 2030
2. Patsnap Synapse - Amgen Announces Q2 2024 Financial Results
3. Managed Healthcare Executive - Prolia and Xgeva Biosimilar Companies Are Queuing Up
4. Amgen - AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS
5. Finimize - Amgen Shines With Earnings Boost From Repatha And Prolia