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Last Updated: February 7, 2025

NEUPOGEN Drug Profile


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Recent Clinical Trials for NEUPOGEN

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Medical College of WisconsinPhase 1
Newlife Fertility CentrePhase 4
St. Jude Children's Research HospitalPhase 1/Phase 2

See all NEUPOGEN clinical trials

Recent Litigation for NEUPOGEN

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
Pandora Marketing LLC2024-01-31
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.2023-01-19
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN INC.2021-07-28

See all NEUPOGEN litigation

PTAB Litigation
PetitionerDate
2016-09-15
2012-09-25

See all NEUPOGEN litigation

Pharmacology for NEUPOGEN
Physiological EffectIncreased Myeloid Cell Production
Established Pharmacologic ClassLeukocyte Growth Factor
Chemical StructureGranulocyte Colony-Stimulating Factor
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 NEUPOGEN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for NEUPOGEN 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. NEUPOGEN filgrastim Injection 103353 4,810,643 2006-03-07 Company disclosures
Amgen Inc. NEUPOGEN filgrastim Injection 103353 4,999,291 Company disclosures
Amgen Inc. NEUPOGEN filgrastim Injection 103353 5,528,823 Company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

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

These patents were obtained by searching patent claims

Supplementary Protection Certificates for NEUPOGEN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
SPC/GB14/009 United Kingdom ⤷  Try for Free PRODUCT NAME: LIPEGFILGRASTIM; REGISTERED: UK EU/1/13/856/001 20130729
C 2014 004 Romania ⤷  Try for Free PRODUCT NAME: LIPEGFILGRASTIM; NATIONAL AUTHORISATION NUMBER: EU/1/13/856; DATE OF NATIONAL AUTHORISATION: 20130725; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/856; DATE OF FIRST AUTHORISATION IN EEA: 20130725
2014C/003 Belgium ⤷  Try for Free PRODUCT NAME: LIPEGFILGRASTIM; AUTHORISATION NUMBER AND DATE: EU/1/13/856 20130729
>Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for the Biologic Drug: Neupogen

Introduction

Neupogen, a brand name for the biologic drug filgrastim, is a granulocyte-colony stimulating factor (G-CSF) used primarily to reduce the incidence of infection, in cases of strong-dosed chemotherapy-induced neutropenia. Here, we delve into the market dynamics and financial trajectory of Neupogen, a drug that has been a cornerstone in cancer care for decades.

Market Size and Growth

The global filgrastim market, which includes Neupogen, is projected to grow significantly over the coming years. By 2031, the market is expected to reach $745.1 million, growing at a Compound Annual Growth Rate (CAGR) of 3.2% from 2023 to 2031. This growth is driven by increasing demand for hematopoietic support in cancer care and the expanding use of filgrastim in various medical indications[1].

Market Segments

The filgrastim market is segmented based on drug type, indication, distribution channel, and region. The drug type segment includes both originator and biosimilar products. Biosimilars have become a significant factor in the market dynamics, offering cost-effective alternatives to the original biologic drugs.

Biosimilar Impact

Biosimilars have dramatically altered the market landscape for Neupogen. As of Q3 2023, biosimilars have captured an impressive 86% of the filgrastim market share in the US. The first filgrastim biosimilar launched in the US market has been the market leader since Q3 2018. This shift has led to a substantial reduction in the Average Sales Price (ASP) of filgrastim products, with biosimilars averaging $148, a 67% decrease from the reference product's ASP at the time of the first biosimilar launch[4].

Financial Performance of Amgen

Amgen, the original manufacturer of Neupogen, has seen mixed financial results in recent years. For the full year 2023, Amgen's total revenues increased by 7% to $28.2 billion, driven by a 9% increase in product sales. However, the revenue growth from Neupogen specifically has been impacted by the rise of biosimilars. In 2022, Neupogen sales were $144 million, down 14% from the previous year[5].

Revenue and Profit Margins

The introduction of biosimilars has not only reduced the ASP but also eroded the market share of the original Neupogen. This has resulted in lower revenues and profit margins for Amgen. For instance, the GAAP operating margin for Amgen decreased by 9.3 percentage points to 29.3% for the full year 2023, partly due to the increased competition from biosimilars and other operational expenses[2].

Cash Flow and Balance Sheet

Amgen's cash flow has also been affected by the changing market dynamics. The company generated $7.4 billion in free cash flow for the full year 2023, down from $8.8 billion in 2022. This decrease was primarily driven by transaction expenses related to the Horizon acquisition and higher repatriation tax payments. Despite this, Amgen maintains a strong balance sheet with cash and investments totaling $10.9 billion as of December 31, 2023[2].

Regional Market Dynamics

The filgrastim market is diverse across different regions, including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. The adoption of biosimilars varies significantly across these regions, with the US market being one of the most mature in terms of biosimilar penetration[1].

Competitive Landscape

The competitive landscape for Neupogen is highly competitive, with multiple biosimilars available in the market. Brands like Zarxio, Nivestym, and Releuko have gained significant market share, challenging the dominance of Neupogen. This competition has driven down prices and increased the bargaining power of healthcare providers and patients[4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of biologic drugs like Neupogen. Biologic markets typically open to follow-on protein product (FoPP) competition after the expiry of patents and data exclusivity periods. This has allowed biosimilars to enter the market, providing more affordable options for patients[3].

Patient Impact

The availability of biosimilars has significantly benefited patients by reducing the financial burden associated with filgrastim treatment. The estimated price discounts associated with FoPP entry have resulted in an additional increase in the overall demand for these products, making them more accessible to a wider patient population[3].

Future Outlook

The future outlook for Neupogen and the broader filgrastim market is marked by continued competition from biosimilars. As more biosimilars enter the market, the ASP is expected to decrease further, impacting the revenue and profit margins of the original biologic drug manufacturers. However, this competition also drives innovation and improves patient access to essential medications.

Key Takeaways

  • The global filgrastim market is projected to reach $745.1 million by 2031, growing at a CAGR of 3.2%.
  • Biosimilars have captured a significant market share, reducing the ASP of filgrastim products.
  • Amgen's financial performance has been impacted by the rise of biosimilars, leading to lower revenues and profit margins.
  • The competitive landscape is highly competitive, with multiple biosimilars challenging the original Neupogen.
  • The regulatory environment supports the entry of biosimilars, benefiting patients by making treatments more affordable.

FAQs

What is Neupogen and its primary use?

Neupogen, or filgrastim, is a biologic drug used to reduce the incidence of infection in patients undergoing strong-dosed chemotherapy-induced neutropenia.

How has the market share of Neupogen been affected by biosimilars?

As of Q3 2023, biosimilars have captured 86% of the filgrastim market share in the US, significantly reducing the market share of the original Neupogen.

What is the projected market size for filgrastim by 2031?

The global filgrastim market is expected to reach $745.1 million by 2031, growing at a CAGR of 3.2% from 2023 to 2031.

How have biosimilars impacted the Average Sales Price (ASP) of filgrastim products?

Biosimilars have reduced the ASP of filgrastim products by 67%, with the average ASP for biosimilars alone being $148 as of Q1 2024.

What are the key factors driving the growth of the filgrastim market?

The growth is driven by increasing demand for hematopoietic support in cancer care and the expanding use of filgrastim in various medical indications.

Sources

  1. Globenewswire: Filgrastim Market is set to Reach US$ 745.1 million at a CAGR of 3.2% from the forecast period 2023 to 2031 - Growth Plus Reports.
  2. PR Newswire: AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS.
  3. ASPE: Economic Analysis of Availability of Follow-on Protein Products.
  4. Samsung Bioepis: Biosimilar Market Report - Q1 2024.
  5. Amgen: AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS.

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