REGRANEX Drug Profile

Summary for Tradename: REGRANEX

High Confidence Patents:	1
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for REGRANEX
Recent Clinical Trials:	See clinical trials for REGRANEX

See drug prices for REGRANEX

Recent Clinical Trials for REGRANEX

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Institutes of Health (NIH)	Phase 1
NYU Langone Health	Phase 1
Genzyme, a Sanofi Company	Phase 1

See all REGRANEX clinical trials

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 REGRANEX Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for REGRANEX 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
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691	5,457,093	2013-10-12	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for REGRANEX 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
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691	10,111,968	2036-08-10	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691	10,118,956	2035-11-30	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691	10,143,755	2037-12-08	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691	10,350,093	2035-12-23	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691	10,478,394	2036-03-10	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691	10,656,152	2037-11-08	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691	10,953,073	2038-09-17	Patent claims search

International Patents for REGRANEX

Country	Patent Number	Estimated Expiration
South Africa	968398
Portugal	859596
Spain	2167611
Greece	880100617
Mexico	169808
Czech Republic	102498
Poland	187174

Supplementary Protection Certificates for REGRANEX

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C990016	Netherlands		PRODUCT NAME: BECAPLERMINUM; REGISTRATION NO/DATE: EU/1/99/101/001 19990329
99C0034	Belgium		PRODUCT NAME: BECAPLERMIN; REGISTRATION NO/DATE: EU/1/99/101/001 19990329
SPC/GB99/023	United Kingdom		PRODUCT NAME: BECAPLERMIN; REGISTERED: UK EU/1/99/101/001 19990329
SZ 36/1999	Austria		PRODUCT NAME: BECAPLERMIN

Market Dynamics and Financial Trajectory for REGRANEX: A Comprehensive Analysis

Last updated: September 29, 2025

Introduction

REGRANEX (becaplermin) stands as a pioneering topical biologic indicated primarily for the treatment of diabetic foot ulcers (DFUs). Since its initial FDA approval in 1997, REGRANEX has played a significant role in the wound healing segment, leveraging recombinant human platelet-derived growth factor (PDGF-BB) to stimulate tissue regeneration. As the landscape of diabetic wound management evolves, understanding the compound's market dynamics and financial trajectory is imperative for industry stakeholders. This analysis explores the current market environment, competitive landscape, regulatory influences, and future financial prospects of REGRANEX within the biologic therapeutics sector.

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Market Overview and Demand Drivers

Prevalence of Diabetic Foot Ulcers

Diabetic foot ulcers represent a substantial burden worldwide, affecting approximately 15% of patients with diabetes during their lifetime [1]. The rising global incidence of diabetes, compounded by aging populations and expanded awareness of wound management options, fuels increased demand for efficacious therapies like REGRANEX.

Efficacy and Clinical Adoption

REGRANEX's mechanism—stimulating angiogenesis and cellular proliferation—offers a targeted approach distinct from traditional wound care. Its approval was expedited via the Fast Track process, reflecting clinical confidence in its efficacy [2]. Nevertheless, clinical adoption is tempered by factors such as cost, administration complexity, and competition from emerging biologics.

Market Segmentation

The primary market resides within diabetic foot ulcer management, with secondary applications emerging in other chronic wound types and tissue regeneration arenas. The product holds particular appeal in healthcare systems prioritizing advanced wound care, especially in developed markets like the U.S., Europe, and Japan.

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Competitive Landscape and Market Share Dynamics

Existing Therapeutics

REGRANEX's key competitors include:

• Autologous skin grafts and dermal substitutes: Established but resource-intensive.
• Other biologics and growth factors: Emerging agents employing platelet-rich plasma (PRP) or synthetic growth factors.
• Standard wound care: Bandages, debridement, and offloading remain baseline treatments.

While REGRANEX was the first FDA-approved PDGF therapy, it now faces competition from newer biologics claiming improved efficacy or cost advantages.

Market Penetration Challenges

The high cost of REGRANEX (~$1,000–$1,500 per treatment course) constrains widespread utilization, especially in cost-sensitive healthcare environments. Additionally, ease of application influences market penetration; REGRANEX requires daily topical administration over extended periods, which may hinder compliance.

Patent and Regulatory Considerations

First-mover advantage endowed REGRANEX with early market dominance. However, patent expirations and the advent of biosimilars or alternative therapies threaten market share. Regulatory shifts emphasizing cost-effectiveness may further influence prescribing behaviors.

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Regulatory and Reimbursement Influences

Regulatory Environment

While FDA approval facilitated market entry in the U.S., evolving regulatory standards for biologics, including biosimilars, could impact REGRANEX's operational landscape. Accelerated approval pathways and post-market surveillance shape future product positioning.

Reimbursement Policies

Insurance coverage significantly influences product utilization. Payers have historically scrutinized the cost-effectiveness of REGRANEX, favoring less expensive wound management options. However, reimbursement rates are evolving as evidence of clinical benefit accumulates, especially regarding reduction in healing time and limb amputation rates.

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Financial Trajectory and Market Outlook

Historical Revenue Performance

Previously, REGRANEX achieved peak global revenues estimated around $200 million annually in the early 2000s [3]. However, subsequent years saw a decline due to market saturation, high costs, and increased competition. Financial performance has largely plateaued or declined in mature markets, with only niche applications maintaining steady demand.

Impact of Patent Expiry and Biosimilars

The expiration of key formulation patents around the late 2000s opened the door to biosimilar competition, although no biosimilar versions of becaplermin have achieved broad market penetration yet. The pharmaceutical industry’s cautious approach to biosimilars in biologics like REGRANEX stems from manufacturing complexities and patent litigation.

Growth Opportunities

Emerging indications and market expansion into developing economies offer growth avenues. Additionally, integration with digital wound care management and tailored application protocols could improve efficacy perceptions, driving increased utilization.

Potential Drivers for Future Revenue

• Innovation in formulation and delivery: Enhancements reducing cost or improving ease of use.
• Expanded indications: Beyond DFUs, such as pressure ulcers or venous leg ulcers.
• Strategic partnerships: Collaborations with healthcare providers and payers to demonstrate cost-saving benefits.

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Market Challenges and Risks

• Pricing pressures: Payer push for value-based reimbursement may curtail revenue potential.
• Limited adoption in low-resource settings: Cost and logistical barriers hinder global expansion.
• Emerging competitors: Novel biologics and regenerative approaches threaten market share.
• Operational complexities: Manufacturing of recombinant proteins involves high costs, impacting profitability.

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Future Outlook

The biologics sector’s trajectory indicates a shift toward personalized and regenerative therapies. REGRANEX’s status as a first-in-class agent confers a competitive edge, yet sustainability depends on strategic repositioning. Realizing growth hinges on diversifying applications, optimizing manufacturing, and demonstrating economic value through rigorous clinical data.

In conclusion, REGRANEX operates within a dynamic environment characterized by technological advances, regulatory shifts, and evolving payer policies. While mature in certain geographies, opportunities persist in expanding indications and markets. The future financial trajectory will be shaped by innovation, strategic partnerships, and the global emphasis on cost-effective diabetic wound care.

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Key Takeaways

• Market demand is driven by rising diabetes prevalence and the need for advanced wound care solutions.
• Cost, administration complexity, and competition limit REGRANEX’s market penetration in mature markets.
• Patent expirations and biosimilar development pose potential revenue challenges but have yet to significantly impact REGRANEX.
• Innovation in delivery and expanding indications can unlock new growth avenues.
• Economic evaluations underscoring cost savings are critical for favorable reimbursement and increased adoption.

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FAQs

1. What is the current market status of REGRANEX?
REGRANEX's global sales have plateaued due to market saturation, high costs, and competition. Its primary demand persists in niche indications like diabetic foot ulcers within developed healthcare systems.

2. How does REGRANEX compare to newer biologics?
While REGRANEX was pioneering as a PDGF-based therapy, newer agents utilize alternative growth factors, delivery systems, or regenerative techniques, challenging its market share.

3. What factors influence REGRANEX’s pricing and reimbursement?
Payers evaluate clinical efficacy, cost-effectiveness, and comparative advantages. The high treatment costs constrain reimbursement unless compelling economic benefits are demonstrated.

4. Are biosimilars impacting REGRANEX's market?
No biosimilars are currently available for becaplermin. Patent expirations could eventually lead to biosimilar development, potentially affecting market competitiveness.

5. What strategies could extend REGRANEX’s financial viability?
Expanding indications, improving delivery mechanisms, forming strategic partnerships, and generating robust health economics data can support sustained market relevance.

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Sources

[1] American Diabetes Association, "6. Microvascular Complications and Foot Care," Diabetes Care, 2022.
[2] U.S. Food and Drug Administration, "Regranex (becaplermin) Gel," 1997.
[3] MarketResearch.com, "Diabetic Wound Care Market Analysis," 2019.