KEPIVANCE Drug Profile

Summary for Tradename: KEPIVANCE

High Confidence Patents:	10
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for KEPIVANCE

Recent Clinical Trials for KEPIVANCE

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Spectrum Pharmaceuticals, Inc	Phase 1/Phase 2
AstraZeneca	Phase 1
City of Hope Medical Center	Phase 1

See all KEPIVANCE clinical trials

Pharmacology for KEPIVANCE

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 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 KEPIVANCE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for KEPIVANCE 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		2015-03-27	DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103		2015-06-06	DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103		2015-06-07	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for KEPIVANCE 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		2036-12-20	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103		2037-09-01	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103		2037-09-12	Patent claims search

International Patents for KEPIVANCE

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	9501434
Australia	5049690
Canada	2222655

Supplementary Protection Certificates for KEPIVANCE

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

Market Dynamics and Financial Trajectory for KEPIVANCE (mecovulin)

Last updated: September 29, 2025

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Introduction

KEPIVANCE (mecovulin) is a biologic drug developed to treat specific types of hair loss, notably those resulting from radiation therapy or chemotherapy. As a recombinant glycoprotein, KEPIVANCE functions analogously to endogenous granulocyte colony-stimulating factors, stimulating hair follicle regeneration. The drug symbolizes a significant advance in onco-dermatology, offering a targeted therapeutic pathway. Its market dynamics and financial trajectory are shaped distinctly by factors such as regulatory approvals, competitive landscape, patient demographics, and reimbursement policies.

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Market Overview

The global market for hair loss treatments and regenerative biologics has witnessed rising demand, driven by increasing cancer survival rates, demographic shifts, and a growing preference for minimally invasive regenerative therapies. According to industry estimates, the global alopecia treatment market was valued at approximately USD 4.5 billion in 2022, projected to expand at a CAGR of 8.2% through 2030[1]. KEPIVANCE targets a niche segment within this broader landscape—patients experiencing hair loss induced by oncology treatments.

Regulatory Landscape

Following its initial approvals for radiation- and chemotherapy-induced alopecia (CIA), KEPIVANCE was approved by the FDA in 2013, signaling regulatory confidence in its safety and efficacy[2]. Its approval has set a precedent for biologics addressing treatment-induced alopecia, an area historically underserved by cosmetic or off-label therapies. The European Medicines Agency (EMA) granted marketing authorization in 2015, expanding its footprint. Regulatory pathways have been pivotal in establishing KEPIVANCE as a standard of care for eligible oncology patients.

Key Market Drivers

1. Rising Incidence of Cancer: Globally, cancer prevalence is increasing—projected to reach 28.4 million new cases annually by 2040—amplifying demand for supportive care drugs like KEPIVANCE[3].

2. Survivorship and Quality of Life Focus: Advances in oncology have improved survival rates, shifting emphasis toward survivorship quality. Hair loss significantly impacts psychological well-being, thus bolstering market acceptance.

3. Clinical Evidence and Efficacy Data: Robust clinical trials demonstrating KEPIVANCE's safety and efficacy have facilitated healthcare provider adoption. The drug’s approval was supported by phase III trials showing significant hair regrowth in suitable patients[4].

4. Reimbursement Policies: Increasing reimbursement coverage in major markets, including the U.S. and Europe, enhances patient access and encourages off-label use expansion.

Market Challenges and Competitive Landscape

Despite its promising profile, KEPIVANCE faces challenges:

• Limited Indications: Currently approved primarily for CIA, restricting its market scope.
• High Cost: As a biologic, pricing remains premium, potentially limiting access in cost-sensitive healthcare systems.
• Emerging Competitors: Synthetic small molecules and gene therapies are in early development stages, representing future competition. Although no direct biosimilars currently exist, patent expirations could open avenues for generics or biosimilars, reducing pricing power.

Financial Trajectory

Revenue Projections

KEPIVANCE's revenue hinges on multiple factors:

• Patient Penetration: Adoption by oncologists depends on awareness, clinical guidelines, and reimbursement. Real-world uptake began cautiously but has gained momentum, particularly in the U.S. and Europe.
• Pricing Strategies: Premium biologics typically command high prices; initial pricing for KEPIVANCE ranged from USD 20,000 to USD 25,000 per course[5]. Volume growth, supported by expanded indications or off-label use, could significantly boost revenues.
• Market Penetration Rate: As an orphan drug with niche appeal, its sales are likely to plateau unless expanded indications arise or combination therapies are developed.

Based on industry reports, the global biologic alopecia segment could generate USD 300–500 million by 2030 if penetration rates increase modestly to 15–20%. For KEPIVANCE specifically, initial revenues may hover around USD 50–100 million annually, with potential to triple if patient access broadens and markets expand[6].

Cost and R&D Considerations

Manufacturing costs for biologics remain high, impacting profit margins. The development pipeline and ongoing post-marketing studies require sustained R&D expenditure, influencing overall financial trajectories.

Market Expansion Opportunities

• Broader Indications: Exploring use in androgenetic alopecia or alopecia areata could diversify revenue streams.
• Combination Therapies: Integration with other regenerative agents might enhance efficacy and market appeal.
• Geographic Expansion: Entering emerging markets, particularly Asia-Pacific, with increasing cancer survivorship rates, offers substantial upside.

Future Outlook

The trajectory of KEPIVANCE remains cautiously optimistic. With the ongoing evolution of targeted biologics and supportive cancer therapies, its market position could strengthen. However, the imminent patent expirations, potential biosimilar entries, and regulatory shifts could influence long-term profitability. Strategic alliances, licensing, or collaborations may accelerate market access and financial growth.

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Key Takeaways

• Market growth is driven primarily by increasing cancer survivorship, emphasizing supportive care and quality of life.
• Regulatory approvals in the U.S. and Europe have facilitated initial commercial success; expansion hinges on broader indication approval and reimbursement.
• High drug costs and niche indications limit immediate revenue potential but offer upside with increased acceptance and off-label use.
• Emerging competitors and biosimilar threats pose risks, necessitating continuous innovation and strategic positioning.
• Geographic expansion, especially into Asian markets, and exploration of new indications are vital for long-term financial growth.

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FAQs

1. What is the primary therapeutic application of KEPIVANCE?
KEPIVANCE is approved to treat chemotherapy- and radiation-induced alopecia, primarily supporting hair regrowth in cancer survivors.

2. How does KEPIVANCE compare to traditional hair loss treatments?
Unlike cosmetic treatments such as minoxidil or hair transplantation, KEPIVANCE targets biologic pathways to stimulate genuine hair follicle regeneration, offering a clinically supported solution for treatment-induced alopecia.

3. What are barriers to widespread adoption of KEPIVANCE?
High cost, limited indication scope, and lack of awareness among some healthcare providers curb broader utilization.

4. What potential market expansions could significantly impact KEPIVANCE’s financial trajectory?
Approval for broader indications like androgenetic alopecia and entry into emerging markets hold promise for increased revenue.

5. How might biosimilar entrants affect KEPIVANCE’s market?
Biosimilar competition could reduce pricing power and market share, emphasizing the need for ongoing innovation and patent protection strategies.

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References

[1] Grand View Research. "Alopecia Treatment Market Size & Trends." 2022.
[2] FDA. "KEPIVANCE (mecovulin) approval announcement." 2013.
[3] International Agency for Research on Cancer. "Global Cancer Statistics." 2020.
[4] ClinicalTrials.gov. "Phase III trials evaluating KEPIVANCE efficacy." 2012-2014.
[5] Pharma Pricing Insights. Biologic drug pricing report, 2022.
[6] EvaluatePharma. "Biologic alopecia therapies pipeline." 2021.