INFUGEM Drug Patent Profile

When do Infugem patents expire, and when can generic versions of Infugem launch?

Infugem is a drug marketed by Sun Pharm and is included in one NDA. There is one patent protecting this drug.

This drug has seventeen patent family members in fourteen countries.

The generic ingredient in INFUGEM is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Infugem

A generic version of INFUGEM was approved as gemcitabine hydrochloride by HOSPIRA INC on November 15^th, 2010.

Summary for INFUGEM

International Patents:	17
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	2
Patent Applications:	6,801
Drug Prices:	Drug price information for INFUGEM
What excipients (inactive ingredients) are in INFUGEM?	INFUGEM excipients list
DailyMed Link:	INFUGEM at DailyMed

See drug prices for INFUGEM

Recent Clinical Trials for INFUGEM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Alkermes, Inc.	Phase 3
Merck Sharp & Dohme Corp.	Phase 3
Stanford University	Phase 2

See all INFUGEM clinical trials

US Patents and Regulatory Information for INFUGEM

INFUGEM is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-001	Jul 16, 2018		DISCN	Yes	No			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-007	Jul 16, 2018		DISCN	Yes	No			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-004	Jul 16, 2018		DISCN	Yes	No			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-008	Jul 16, 2018		DISCN	Yes	No			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-002	Jul 16, 2018		DISCN	Yes	No			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-003	Jul 16, 2018		DISCN	Yes	No			Y

International Patents for INFUGEM

See the table below for patents covering INFUGEM around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	2656848
South Africa	201408502	READY TO BE INFUSED GEMCITABINE SOLUTION
Japan	2013231029	READY TO BE INFUSED GEMCITABINE SOLUTION
Brazil	112014026334
Canada	2871061	SOLUTION DE GEMCITABINE PRETE A ETRE PERFUSEE (READY TO BE INFUSED GEMCITABINE SOLUTION)
Portugal	2656848

Supplementary Protection Certificates for INFUGEM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0122707	SPC/GB95/031	United Kingdom		PRODUCT NAME: GEMCITABINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY- ACCEPTABLE SALT; REGISTERED: NL RVG17854 19950327; UK 00006/0301 19951026; UK 00006/0302 19951026
0122707	96C0030	Belgium		PRODUCT NAME: CHLORHYDRATE DE GEMCITABINE EQUIVALENT EN GEMCITABINE; NAT. REGISTRATION NO/DATE: 58 IS 88 F 12 19960606; FIRST REGISTRATION: NL RVG 17854 19950327

Market Dynamics and Financial Trajectory for INFUGEM

Last updated: July 27, 2025

Introduction

INFUGEM, a recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF), is a biologic therapy primarily approved for treating neutropenia and enhancing hematopoietic recovery post-chemotherapy or bone marrow transplantation. As a critical therapeutic option within oncology and infectious disease settings, INFUGEM’s market trajectory is influenced by evolving clinical needs, regulatory landscapes, and competitive dynamics. This analysis delves into the market drivers, competitive positioning, and financial prospects shaping INFUGEM’s future.

Market Overview and Segmentation

The global granulocyte-macrophage colony-stimulating factor market is projected to grow steadily, driven by increasing cancer incidence, expanding hematologic disorder treatments, and advances in supportive care protocols. Key segments relevant to INFUGEM include:

• Oncology supportive care: Particularly in managing chemotherapy-induced neutropenia.
• Hematopoietic stem cell transplantation (HSCT): Enhancing engraftment efficiency.
• Infections: Adjunct therapy in immunocompromised populations.

Market segmentation also hinges on geographic regions, with North America leading due to high adoption rates, followed by Europe and Asia-Pacific, where rising cancer prevalence and healthcare infrastructure investments foster growth.

Market Drivers

Increasing Cancer Burden and Chemotherapy Use

Globally, cancer incidence is escalating, notably across Asia-Pacific and Latin America, fueling demand for supportive therapies like INFUGEM. According to GLOBOCAN 2020 data, there are over 19.3 million new cases annually worldwide, many of which require chemotherapy regimens associated with neutropenia. INFUGEM’s capacity to reduce infection risk and hospitalization duration improves patient outcomes and aligns with cost-containment strategies.

Advancements in Hematologic Disorder Management

The rise in hematologic malignancies, including leukemia and lymphoma, necessitates supportive biologics. INFUGEM’s role in facilitating engraftment post-bone marrow transplant contributes to its clinical appeal and market expansion.

Regulatory Approvals and Reimbursement Policies

Enhanced regulatory support, including approvals for expanded indications in several countries, has widened INFUGEM’s clinical utility. Reimbursement schemes favor biologics that demonstrate cost-effectiveness and patient benefits, bolstering sales.

Healthcare Infrastructure and Adoption Trends

Growing healthcare infrastructure investments, especially in emerging markets, facilitate access to complex biologic treatments. Additionally, receptor-specific therapy protocols and personalized medicine approaches amplify reliance on biologics like INFUGEM.

Competitive Landscape

INFUGEM faces competition from other rhGM-CSF formulations, such as sargramostim (e.g., Leukine) and biosimilars entering markets post-patent expiry. Market entrants often emphasize manufacturing efficiency, affordability, and evidence-based advantages to secure market share.

Major pharmaceutical players include:

• Biosimilar manufacturers: Entering aggressive price competition, impacting INFUGEM’s margins.
• Innovator companies: Focusing on novel formulations, delivery systems, and combination therapies.
• Biotech startups: Exploring next-generation cytokine therapies and targeted agents to replace or supplement existing options.

The patent status and regulatory exclusivities heavily impact INFUGEM’s market penetration. While some patents have lapsed or are nearing expiry, strategic lifecycle management—including new indications and combination protocols—is used to sustain revenue.

Pricing and Reimbursement Outlook

Pricing strategies significantly influence INFUGEM’s market trajectory. In high-income markets, reimbursement policies focus on cost-effectiveness, emphasizing reduced hospitalization and complication rates. Conversely, in emerging markets, affordability drives biosimilar integration, pressuring previous price points.

Health technology assessments (HTAs), such as those by NICE or the Pharmaceutical Benefits Scheme (PBS), scrutinize clinical benefit versus cost, impacting formulation adoption.

Financial Projections and Revenue Potential

Current Financial Performance

Available data suggest INFUGEM’s sales are robust within niche supportive care markets, with revenues sustained by extensive clinical use and expanding indications. However, they face margin pressures from biosimilar competition and pricing constraints.

Future Revenue Streams

Projected growth hinges on several factors:

• Expansion of indications: Including new supportive care applications or combination therapies.
• Geographic expansion: Penetration into emerging markets with high unmet needs.
• Product lifecycle strategies: Such as implementing next-generation delivery systems or developing biosimilar versions with competitive pricing.

Market Entry Risks

Potential risks include regulatory delays, patent litigations, and the advent of novel therapeutics, such as cytokine mimetics or gene therapies, which could displace INFUGEM’s role.

Financial Outlook

Analysts predict modest compound annual growth rates (CAGR) of 3-6% over the next five years for INFUGEM-centric markets, driven by increasing oncological treatment needs. The global rhGM-CSF market could approach USD 1.2 billion by 2027, with INFUGEM positioning to capture a significant share, contingent on strategic market management.

Regulatory and Ethical Considerations

Regulatory agencies prioritize biosimilar equivalence, safety, and efficacy, influencing INFUGEM’s market exclusivity timeline. Strict compliance and post-marketing surveillance are essential for sustained market access. Ethical considerations around affordability and access, especially in low- and middle-income countries, impact pricing negotiations and public health policies.

Conclusion

INFUGEM’s market dynamic is characterized by robust underlying demand driven by cancer prevalence and supportive care needs, tempered by mounting biosimilar competition and pricing pressures. Strategic lifecycle management, geographic expansion, and clinical innovation are integral to realizing its financial trajectory.

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Key Takeaways

• Growing Oncology and Hematology Markets: Rising cancer and hematologic disorder cases underpin demand for INFUGEM.
• Competitive Landscape: Biosimilars and new biologic agents pose competitive threats, necessitating differentiation strategies.
• Pricing and Reimbursement Strategies: Critical for sustaining revenue, particularly in emerging markets.
• Regulatory Landscape: Evolving approvals and biosimilar regulations influence market access and exclusivity.
• Future Growth Drivers: Indication expansion, geographic penetration, and product innovation offer pathways for revenue growth.

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FAQs

1. What factors influence INFUGEM’s market growth?
Market growth depends on rising cancer and hematologic disorder rates, regulatory approvals, competitive biosimilar entries, reimbursement policies, and clinical innovation.

2. How does biosimilar competition impact INFUGEM’s financial outlook?
Biosimilars exert pricing pressures, reducing market share and margins. Effective lifecycle management and differentiation are essential to mitigate these effects.

3. Are there emerging indications that could expand INFUGEM’s use?
Potential new uses include adjunct therapy in infectious diseases and broader application in immune modulation, but these require clinical validation and regulatory approval.

4. What geographic markets offer the most growth potential for INFUGEM?
Emerging markets in Asia-Pacific and Latin America present significant growth opportunities due to increasing cancer burden and expanding healthcare infrastructure.

5. How do regulatory changes influence INFUGEM’s commercial prospects?
Regulatory shifts, including biosimilar guidelines and approval pathways, directly impact market access, timing, and competitive positioning.

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Sources:
[1] GLOBOCAN 2020. Globocan. International Agency for Research on Cancer.
[2] EvaluatePharma. 2022. Oncology Market Data Report.
[3] FDA and EMA approval databases.
[4] Market research reports on biologics and biosimilars.