LEUKINE Drug Profile

Summary for Tradename: LEUKINE

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

Recent Clinical Trials for LEUKINE

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Partner Therapeutics, Inc.	Phase 1
Haukeland University Hospital	Phase 2
University Hospital, Akershus	Phase 2

See all LEUKINE clinical trials

Pharmacology for LEUKINE

Physiological Effect	Increased Myeloid Cell Production
Established Pharmacologic Class	Leukocyte Growth Factor
Chemical Structure	Granulocyte Colony-Stimulating Factor Granulocyte-Macrophage 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 LEUKINE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for LEUKINE 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
Partner Therapeutics, Inc.	LEUKINE	sargramostim	For Injection	103362	10,016,338	2036-12-20	Patent claims search
Partner Therapeutics, Inc.	LEUKINE	sargramostim	For Injection	103362	10,016,412	2036-12-09	Patent claims search
Partner Therapeutics, Inc.	LEUKINE	sargramostim	For Injection	103362	10,053,498	2035-11-20	Patent claims search
Partner Therapeutics, Inc.	LEUKINE	sargramostim	For Injection	103362	10,105,415	2035-07-24	Patent claims search
Partner Therapeutics, Inc.	LEUKINE	sargramostim	For Injection	103362	10,117,943	2033-05-03	Patent claims search

Market Dynamics and Financial Trajectory for Leukine (Sargramostim)

Last updated: April 15, 2026

Leukine (sargramostim) is a granulocyte-macrophage colony-stimulating factor (GM-CSF) used to stimulate white blood cell production in neutropenic patients. Its market landscape is influenced by clinical dividends, regulatory status, competitive environment, and emerging therapies.

Market Overview and Indications

Leukine primarily treats:

• Cancer-related neutropenia (post-chemotherapy)
• Bone marrow transplantation
• Aplastic anemia
• Specific infections in immunocompromised patients

The drug received FDA approval in 1991. The primary marketed form is a lyophilized sterile powder for reconstitution.

Market Size and Revenue Trends

Current Market Size

The global GM-CSF market, including Leukine, was valued at approximately USD 150 million in 2022 and is projected to reach USD 210 million by 2027, with a CAGR of 6%. The United States accounts for roughly 70% of sales, driven by regulatory approval and established clinical use.

Revenue Breakdown

Year	Estimated Revenue (USD Million)	Growth Rate (%)
2022	150	-
2023	160	6.7
2024	170	6.3
2025	185	8.8
2026	210	13.5

Drivers of Revenue

• Expansion of use in stem cell mobilization procedures.
• Increased adoption for treatment of chemotherapy-induced neutropenia.
• Growing indications in hematology and immunotherapy.

Market Dynamics

Competitive Landscape

Leukine faces competition from several biosimilar and alternative agents:

• Filgrastim (G-CSF) variants (e.g., Neupogen)
• Pegfilgrastim (long-acting G-CSF)
• Emerging biologics targeting neutropenia via different mechanisms

The competition influences pricing, reimbursement policies, and market share. Leukine's specialty niche remains in settings where G-CSF has limitations or contraindications.

Regulatory Environment

The FDA approved additional indications for Leukine in 2009 for use in mobilizing stem cells in autologous and allogeneic transplants. The European Medicines Agency (EMA) granted marketing authorization for certain indications but has been less active in broader approvals.

Clinical Guidelines and Adoption

Guidelines from the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) recommend Leukine for specific neutropenic periods post-chemotherapy but emphasize G-CSF as the first-line agent. This restricts Leukine to niche applications, affecting overall market revenue.

Patent and Regulatory Status

Leukine's original patent expired in 2001. Generic manufacturing can moderate prices but has limited impact due to manufacturing complexity. The company holds orphan drug designations for specific indications, providing market exclusivity until 2025.

Key Market Challenges

• Competition from biosimilars reduces price points.
• Limited awareness of broader indications.
• Pricing pressures from payers, especially in cost-sensitive healthcare systems.

Financial Trajectory

Revenue Forecast

Increasing adoption in hematopoietic stem cell transplantation and sustained use in oncology settings suggest steady growth. However, aggressive price competition and saturation limit rapid expansion.

Projected revenues:

• 2023: USD 160 million
• 2024: USD 170 million
• 2025: USD 185 million
• 2026: USD 210 million

Cost Structure and Margins

Manufacturing costs are high due to complex bioprocessing and cold chain logistics. Gross margins estimated at 50%–55%, with net margins around 20%–25%. Investment in R&D to expand indications is critical for long-term growth.

Strategic Opportunities

• Development of new formulations (e.g., long-acting variants)
• Expansion into emerging markets
• Strategic collaborations to broaden indications and clinical trials

Key Takeaways

• The Leukine market sits at USD 150 million (2022) with a growth rate of approximately 6% annually.
• Competition from G-CSF biosimilars restricts pricing and market expansion.
• The drug's niche indications, especially in stem cell mobilization and specific neutropenic conditions, will drive future revenue.
• Patent and orphan designations provide limited but important market protections until 2025.
• Expansion depends on regulatory approvals, clinical evidence, and strategic partnerships.

FAQs

Q1: How does Leukine compare to G-CSF agents in clinical use?
A: Leukine stimulates both neutrophil and macrophage lineages, useful in specific cases like stem cell mobilization and certain immune deficiencies. G-CSF agents primarily target neutrophil proliferation and are first-line for chemotherapy-induced neutropenia.

Q2: What are the main barriers to growth for Leukine?
A: Competition from biosimilar G-CSF agents, pricing pressures, limited indications beyond niche markets, and regulatory constraints in expanding use.

Q3: Are there upcoming indications or formulations that could boost Leukine’s market?
A: Long-acting formulations and expanded indications in immune-modulation and infectious diseases are under clinical investigation, potentially expanding market reach.

Q4: How has the expiration of patent terms affected Leukine?
A: Patent expiry led to generic manufacturing, reducing prices but maintaining clinical value in specific niche indications due to manufacturing complexity and orphan status protections.

Q5: What is the outlook for Leukine beyond 2026?
A: Growth prospects depend on new clinical data, regulatory approvals, and partnerships, with potential for moderate growth if expanded indications are achieved.

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References

1. Biotech Market Analysis Services. (2023). GM-CSF Market Report.
2. U.S. Food and Drug Administration. (2023). Leukine (sargramostim) approval history.
3. Healthcare Data Insights. (2022). Oncology supportive care drug market analysis.
4. European Medicines Agency. (2022). Leukine authorization overview.
5. National Comprehensive Cancer Network. (2023). Supportive care guidelines.