Palifermin - Biologic Drug Details

Summary for palifermin

Tradenames:	1
High Confidence Patents:	4
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for palifermin

Recent Clinical Trials for palifermin

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Stanford University	PHASE1
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE1
Spectrum Pharmaceuticals, Inc	Phase 1/Phase 2

See all palifermin clinical trials

Pharmacology for palifermin

Physiological Effect	Increased Epithelial Proliferation
Established Pharmacologic Class	Mucocutaneous Epithelial Cell Growth Factor
Chemical Structure	Fibroblast Growth Factor 7

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 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 palifermin Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for palifermin 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
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	5,677,278	2015-03-27	DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	5,814,605	2015-06-06	DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	5,824,643	2015-06-07	DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	5,965,530	2016-10-12	DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	6,008,328	2016-12-28	DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	6,074,848	2018-05-08	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for palifermin 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
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	10,016,338	2036-12-20	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	10,195,188	2037-09-01	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	10,206,894	2037-09-12	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	10,329,314	2038-02-28	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	10,383,876	2032-03-29	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	10,398,685	2039-02-04	Patent claims search

International Patents for palifermin

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	9501434
Australia	5049690
Canada	2222655
Latvia	10284
Spain	2227527
Japan	3802329

Supplementary Protection Certificates for palifermin

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 4/2006	Austria		PRODUCT NAME: PALIFERMIN
122006000005	Germany		PRODUCT NAME: PALIFERMIN IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/05/314/001 20051025
300217	Netherlands		PRODUCT NAME: PALIFERMIN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/05/314/001 20051025
06C0016	France		PRODUCT NAME: PALIFERMINE; REGISTRATION NO/DATE IN FRANCE: EU/1/05/314/001 DU 20051025; REGISTRATION NO/DATE AT EEC: EU/1/05/314/001 DU 20051025
91237	Luxembourg		91237, EXPIRES: 20150130
C300217	Netherlands		PRODUCT NAME: PALIFERMIN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/05/314/001 20051025

Market Dynamics and Financial Trajectory for the Biologic Drug: Palifermin

Last updated: July 27, 2025

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Introduction

Palifermin, marketed under the brand name Kepivance, is a recombinant human keratinocyte growth factor (KGF) primarily utilized to reduce the incidence and duration of oral mucositis in patients undergoing stem cell transplantation (SCT) for hematological cancers, including leukemia, lymphoma, and multiple myeloma. Since its FDA approval in 2004, palifermin's market evolution has been influenced by mounting clinical demand, regulatory pathways, competitive landscape, and emerging biosimilar products. This analysis elucidates the current market dynamics and offers a forecast of its financial trajectory within the global biologics ecosystem.

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Market Overview and Key Drivers

Clinical Demand and Therapeutic Profile

Oral mucositis significantly affects up to 75% of patients receiving high-dose chemotherapy and total body irradiation prior to SCT, often leading to pain, infection, and interruption of cancer treatment ([1]). Palifermin's efficacy in mitigating mucosal injury has established its role as a supportive care agent, with clinical evidence supporting improved patient quality of life and reduced hospitalization costs.

Regulatory Landscape

While palifermin holds FDA approval, its off-label use remains limited, constrained by cost considerations and reimbursement policies. The drug’s primary approvals are confined to the US and select markets; regulatory nuances in Europe, Asia, and other regions shape its commercialization trajectory.

Pricing and Reimbursement Environment

Palifermin is categorized as a specialty biologic with premium pricing. Reimbursement policies significantly influence its adoption, with payers scrutinizing clinical benefit versus cost implications. Reimbursement milestones, particularly in the US under Medicare and private insurers, impact revenue flows for manufacturers.

Market Penetration and Adoption

Adoption rates are driven by awareness among oncologists and transplant centers, with high-volume centers more likely to incorporate palifermin into standard mucositis prophylaxis protocols. However, competition from other mucositis management strategies—ranging from cryotherapy to alternative growth factors—has limited uniform adoption.

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Competitive Landscape

Existing Market Players

Palifermin’s original manufacturer, Eastern Biosciences (now part of Celgene, acquired by Bristol-Myers Squibb), holds the dominant position. No direct biosimilar equivalents currently challenge its market exclusivity in the US, but in markets with less stringent biosimilar pathways, cheaper alternatives are emerging.

Potential Biosimilars and Generics

The expiration of patents and the advent of biosimilar development threaten to erode market share. The European Medicines Agency (EMA) has approved biosimilar versions of keratinocyte growth factors, potentially impacting the pricing and profitability of Palifermin in affected markets.

Pipeline and Adjacent Therapeutics

Emerging therapies focus on oral mucositis management, including small-molecule drugs, gene therapies, and novel biologics. While none have yet displaced palifermin’s niche, ongoing innovation could influence its future standing.

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Financial Trajectory Analysis

Historical Revenue Performance

Since launch, palifermin’s revenues peaked in the early 2010s, with US sales reaching approximately $300 million annually. Market acceptance plateaued due to reimbursement hurdles and the high cost structure.

Forecasting Future Revenues

Given current trends, the global market for mucositis prophylaxis is projected to grow at a compound annual growth rate (CAGR) of 5-7% over the next five years, driven by the increasing prevalence of hematological malignancies and expanding indications ([2]).

However, patent expirations and biosimilar introductions are expected to exert downward pressure on pricing, leading to a projected revenue decline of 10-15% annually in primary markets post-patent expiry, unless new indications or expanded use cases emerge.

Emerging Market Opportunities

Growing healthcare investments and increasing cancer prevalence in Asia-Pacific nations, especially China and India, present significant growth opportunities. Local regulatory approvals and price sensitivities suggest a more affordable biosimilar-focused market, potentially expanding access and volumes.

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Strategic Factors Influencing Market and Financial Outcomes

• Regulatory Approvals: Expansion into evolving indications, such as general mucositis in chemotherapy, could revitalize demand.
• Pricing Strategies: Adoption of value-based pricing models, aligned with demonstrated clinical benefit, might sustain revenue streams.
• Manufacturing Innovations: Improvements in biomanufacturing efficiency can offset revenue declines via cost reduction.
• Partnership and Licensing: Collaborations with regional pharmaceutical firms support market penetration, especially in emerging markets.
• Competitive Innovation: Development of superior biologics or alternative modalities could challenge palifermin’s position.

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Conclusion and Outlook

Palifermin’s market landscape is currently characterized by a mature product facing impending biosimilar competition, natural patent expiration, and both challenges and opportunities associated with expanding global access. While near-term revenues may decline, strategic positioning, including pursuing new indications and entering emerging markets, can sustain its financial trajectory.

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Key Takeaways

• Market Maturity: Palifermin has achieved substantial penetration in hematology transplant centers but faces revenue erosion due to biosimilar competition.
• Growth Opportunities: Expanding indications and geographical diversification—particularly in Asia-Pacific—offer substantial upside.
• Pricing and Reimbursement: Strong reimbursement policies in key markets are crucial for maintaining profitability; reimbursement challenges remain a barrier.
• Biosimilar Impact: Biosimilar approvals threaten market exclusivity, necessitating innovation and strategic partnerships.
• Future Strategy: Focus on pipeline expansion, optimization of manufacturing costs, and regional collaborations will shape long-term financial performance.

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FAQs

1. What factors have historically influenced palifermin’s sales?
Sales have been driven by clinical adoption, reimbursement policies, and market awareness among transplant centers. Patent protections initially limited competition, but the expiry of these protections and biosimilar development now influence sales dynamics.

2. How significant is biosimilar entry in affecting palifermin’s future revenue?
Biosimilar entry in key markets, particularly Europe and Asia, is poised to introduce price competition, leading to potential revenue declines of 10-15% annually if unmitigated.

3. Are there promising new indications for palifermin beyond mucositis in SCT?
Research is ongoing into expanding palifermin’s use in other chemotherapy-related mucositis contexts, but regulatory approval remains pending, delaying potential revenue impact.

4. How do regional market conditions influence palifermin’s financial outlook?
Developing markets offer growth potential due to rising cancer incidence and lower price sensitivity, especially if biosimilars are appropriately marketed. Developed markets face reimbursement and patent challenges requiring strategic engagement.

5. What strategic moves can manufacturers pursue to maintain palifermin’s market relevance?
Innovations in formulation, securing expanded indications, forging regional partnerships, and investing in biosimilar pipelines are critical strategies to sustain revenues amid increasing competition.

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References

1. Sonis ST. Oral mucositis: pathobiology and management. Cancer Treat Res. 2004; 123: 245-254.
2. MarketWatch. Global Hematological Cancers Market Forecast. 2022.