GRANIX Drug Profile

Summary for Tradename: GRANIX

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for GRANIX

Recent Clinical Trials for GRANIX

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Cedars-Sinai Medical Center	Phase 1/Phase 2
Northwestern University	Phase 2
Northwestern University	Phase 2/Phase 3

See all GRANIX clinical trials

Pharmacology for GRANIX

Physiological Effect	Increased Myeloid Cell Production
Established Pharmacologic Class	Leukocyte Growth Factor
Chemical Structure	Granulocyte 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

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 GRANIX Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

GRANIX Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Granix

Granix, a granulocyte-colony stimulating factor (G-CSF) biosimilar, has been a significant player in the filgrastim market. Here’s an overview of its market dynamics and financial trajectory:

Market Dynamics

1. Market Share

   • Overall Market: As of Q3 2024, Granix holds a notable market share in the filgrastim market, although it is not a biosimilar itself but rather an approved drug under a new drug application pathway[1].
   • Biosimilar Market: The biosimilar filgrastim market has seen significant adoption, with biosimilars like Zarxio and Nivestym dominating the volume market share. As of Q3 2024, biosimilars account for a substantial portion of the filgrastim market, with biosimilar filgrastim claims rising to 60% among office-based providers and 49% among outpatient hospital providers[4].

2. Price Erosion

   • The average sales price (ASP) of filgrastim biosimilars has significantly decreased over time. As of Q3 2024, the average ASP for all filgrastim products is $130, a decline of 75% from the reference product's ASP at the time of the first biosimilar launch[1].

3. Competition

   • The filgrastim market is highly competitive with multiple biosimilars available. This competition has led to price erosion, making biosimilars more affordable and increasing their market share[3].

Financial Trajectory

1. Revenue Growth

   • There is no specific financial data available for Granix itself in the provided sources. However, the overall biosimilar market has seen growth in revenue due to increased adoption and competition.

2. Cost Savings

   • The introduction of biosimilars like Granix has led to significant cost savings in the healthcare system. Savings from biosimilars increased to approximately $8 billion in 2020 alone, more than tripling savings derived from previous years[3].

3. Market Impact

   • The financial impact of biosimilars extends beyond just cost savings. They have also contributed to reduced expenditure growth in oncology, with oncology expenditure growth falling below 10% for the first time in seven years due to the impact of biosimilars and new product launches[3].

Key Takeaways

• Market Share: Biosimilars continue to dominate the filgrastim market, with significant shares among office-based providers and outpatient hospitals.
• Price Erosion: The average sales price of biosimilars has decreased substantially, making them more affordable and increasing their market share.
• Financial Impact: The introduction of biosimilars like Granix has led to significant cost savings and reduced expenditure growth in oncology.

FAQs

1. What is Granix?

   • Granix is a granulocyte-colony stimulating factor (G-CSF) drug, though it is not a biosimilar but rather an approved drug under a new drug application pathway.

2. How has the market share of biosimilars in the filgrastim market changed over time?

   • The market share of biosimilars in the filgrastim market has increased over time, with biosimilar filgrastim claims rising to 60% among office-based providers and 49% among outpatient hospital providers[4].

3. What is the current average sales price (ASP) of biosimilars in the filgrastim market?

   • As of Q3 2024, the average ASP for biosimilars in the filgrastim market is $130, a decline of 75% from the reference product's ASP at the time of the first biosimilar launch[1].

4. How have biosimilars impacted the financial trajectory of healthcare expenditure in oncology?

   • Biosimilars have significantly impacted the financial trajectory of healthcare expenditure in oncology by reducing expenditure growth below 10% for the first time in seven years[3].

5. What are the key drivers of the financial impact of biosimilars like Granix?

   • The key drivers of the financial impact of biosimilars like Granix include increased adoption, competition, and price erosion, leading to significant cost savings and reduced expenditure growth in oncology[3].