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Last Updated: December 22, 2024

PROLIA Drug Profile


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Recent Clinical Trials for PROLIA

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Aristotle University Of ThessalonikiPhase 4
Alvotech Swiss AGPhase 3
mAbxience S.APhase 3

See all PROLIA clinical trials

Recent Litigation for PROLIA

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2018-04-30

See all PROLIA litigation

Pharmacology for PROLIA
Mechanism of ActionRANK Ligand Blocking Activity
Established Pharmacologic ClassRANK 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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 11,459,595 Company disclosures
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
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

3) Low Certainty: US Patents for PROLIA Derived from Patent Text Search

These patents were obtained by searching patent claims

Supplementary Protection Certificates for PROLIA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
PA2010013 Lithuania ⤷  Subscribe PRODUCT NAME: DENOSUMABUM; REGISTRATION NO/DATE: EU/1/10/618/001, 2010 05 26, EU/1/10/618/002, 2010 05 26, EU/1/10/618/003, 2010 05 26, EU/1/10/618/004 20100526
SPC/GB10/043 United Kingdom ⤷  Subscribe 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
CA 2010 00031 Denmark ⤷  Subscribe
C00911342/01 Switzerland ⤷  Subscribe PRODUCT NAME: DENOSUMABUM; REGISTRATION NO/DATE: SWISSMEDIC 60210 03.08.2010
C00951551/01 Switzerland ⤷  Subscribe PRODUCT NAME: DENOSUMABUM; REGISTRATION NO/DATE: SWISSMEDIC 60210 03.08.2010
300465 Netherlands ⤷  Subscribe PRODUCT NAME: DENOSUMAB; REGISTRATION NO/DATE: EU/1/10/618/001-004 20100528
>Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

PROLIA Market Analysis and Financial Projection Experimental

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

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