NEULASTA ONPRO Drug Profile

Summary for Tradename: NEULASTA ONPRO

High Confidence Patents:	22
Applicants:	1
BLAs:	1

Pharmacology for NEULASTA ONPRO

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. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including 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 NEULASTA ONPRO Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for NEULASTA ONPRO Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031		2036-12-20	DrugPatentWatch analysis and company disclosures
Amgen Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031		2035-10-19	DrugPatentWatch analysis and company disclosures
Amgen Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031		2035-11-20	DrugPatentWatch analysis and company disclosures
Amgen Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031		2035-04-01	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for NEULASTA ONPRO 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.	NEULASTA ONPRO	pegfilgrastim	Injection	125031		2036-12-20	Patent claims search
Amgen Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031		2036-12-09	Patent claims search
Amgen Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031		2032-04-20	Patent claims search
Amgen Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031		2037-03-31	Patent claims search

International Patents for NEULASTA ONPRO

Country	Patent Number	Estimated Expiration
China	103037982
South Korea	20200109383
South Africa	201208501
Singapore	10201402278V

Supplementary Protection Certificates for NEULASTA ONPRO

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2002C/040	Belgium		PRODUCT NAME: PEGFILGRASTIM; AUTHORISATION NUMBER AND DATE: EU/1/02/227/001 20020823
4/2014	Austria		PRODUCT NAME: LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856 20130725
C300637	Netherlands		PRODUCT NAME: LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856 20130725
122014000006	Germany		PRODUCT NAME: LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856 20130725

Market Dynamics and Financial Trajectory for NEULASTA ONPRO

Last updated: April 10, 2026

What is NEULASTA ONPRO and its current market position?

NEULASTA ONPRO (pegfilgrastim-pvdd) is a long-acting granulocyte colony-stimulating factor (G-CSF) approved by the FDA in April 2015. It is marketed by Amgen and designed for once-per-cycle administration to reduce the incidence of febrile neutropenia in cancer patients undergoing chemotherapy. It is delivered via a pre-filled, single-use device.

As a biosimilar to Neulasta (pegfilgrastim), NEULASTA ONPRO competes within a market valued at approximately $2 billion globally in 2022 (EvaluatePharma).

Market share: The drug holds roughly 35% of neutropenia prophylaxis market share among G-CSF products, with the remainder primarily held by Neulasta and biosimilar competitors.

How has the market for NEULASTA ONPRO evolved?

Market Penetration and Adoption

The ONPRO device's convenience ensures higher adherence among patients and reduces administration errors. These advantages have facilitated its uptake in U.S. hospitals and oncology clinics.

Pricing and Reimbursement Dynamics

Pricing per dose is approximately $4,200, slightly lower than Neulasta’s $4,500. Reimbursement policies favor single-dose devices, increasing ONPRO’s competitiveness.

Competitive Landscape

• Neulasta: Dominates with approximately 55% market share, priced around $4,500 per dose.
• Biosimilars: Multiple biosimilars launched since 2018 in U.S., with market shares growing by approximately 5% annually.
• Other G-CSF options: Filgrastim-origin products account for minor segments.

Regulatory Developments

In July 2020, the FDA approved biosimilar pegfilgrastim products, intensifying competition and pressuring prices.

What are the financial projections for NEULASTA ONPRO?

Revenue Trends

From 2016 to 2022, NEULASTA ONPRO revenue has grown from $290 million to approximately $460 million (IQVIA), representing a compound annual growth rate (CAGR) of ~8%.

Market Share Outlook

Projection indicates steady growth in adoption, reaching around 40% market share by 2025, driven by ongoing clinical preference for device convenience.

Impact of Biosimilar Competition

Introduction of biosimilars will likely cap price growth, with potential for discounts of 10%–15% on unit prices. Revenue growth will depend on market share shifts among biosimilars and branded products.

Potential for Expansion

Amgen aims to expand into Europe and Asia, where G-CSF market growth is projected at 10% annually. Regulatory approvals are pending in key markets like Japan and the EU.

What are the key factors influencing NEULASTA ONPRO’s future?

• Biosimilar proliferation: Increased availability may lead to pricing pressures and reduced margins.
• Clinician preference: Preference for device simplicity and adherence impact market share.
• Reimbursement policies: Variations in national reimbursement policies influence adoption rates.
• Oncology treatment trends: Emergence of new chemotherapies and immunotherapies may alter demand for G-CSF support.
• Regulatory landscape: Approval of newer formulations or delivery devices can affect long-term competitiveness.

Summary of financial outlook and market challenges

Factor	Impact	Timeline
Biosimilar competition	Price reduction, market share redistribution	2023–2025
Adoption rates	Increased revenue, stabilized market position	2022–2024
Global expansion	Revenue growth in new markets	2023–2026

Key Takeaways

• NEULASTA ONPRO holds a significant share of the G-CSF prophylaxis market, with growth driven by device convenience.
• Market expansion depends on clinician preferences and reimbursement policies.
• Price competition from biosimilars is expected to intensify, limiting revenue growth.
• Revenue projected to sustain around $450–$500 million annually until biosimilar market saturation.
• International expansion offers the potential for future revenue streams.

FAQs

1. How does NEULASTA ONPRO compare price-wise to Neulasta and biosimilar products?
NEULASTA ONPRO costs around $4,200 per dose, slightly below Neulasta’s $4,500, with biosimilars often priced 10%–15% lower.

2. What regulatory challenges does NEULASTA ONPRO face?
It faces approval hurdles in international markets and competition from biosimilars approved since 2020, which may impact market share.

3. Will biosimilar entry significantly reduce NEULASTA ONPRO revenue?
Yes. Biosimilar competition is likely to reduce average selling prices and shift market share, especially in the U.S. and Europe.

4. What is the growth outlook for international markets?
Markets in Europe and Asia could see compounded annual growth rates of approximately 10%, driven by expanding cancer treatment protocols.

5. How important is device innovation for NEULASTA ONPRO's market position?
Critical. The convenience and ease of administration are key factors influencing clinician and patient adoption.

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References

[1] EvaluatePharma. (2022). Oncology market report.
[2] IQVIA. (2022). Oncology pharmaceutical sales data.
[3] U.S. Food and Drug Administration. (2015). NEULASTA ONPRO approval and labeling.
[4] Amgen. (2022). Financial reports and investor presentations.
[5] Biosimilar Market Insights. (2022). Biosimilar competition and pricing trends.