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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

Recent Litigation for REGRANEX

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.	2023-01-19
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN INC.	2021-07-28

See all REGRANEX litigation

Pharmacology for REGRANEX

Established Pharmacologic Class	Human Platelet-derived Growth Factor
Chemical Structure	Platelet-Derived Growth 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. General 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 REGRANEX Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for REGRANEX Derived from 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		2012-10-10	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		2032-02-15	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691		2034-12-01	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691		2033-05-17	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691		2025-04-05	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691		2035-03-11	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691		2029-01-29	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691		2038-09-17	Patent claims search

International Patents for REGRANEX

Country	Patent Number	Estimated Expiration
Brazil	9610790
World Intellectual Property Organization (WIPO)	9712601
Czech Republic	102498
Denmark	0859596
Japan	4001382
Japan	H02112
Canada	2234235

Supplementary Protection Certificates for REGRANEX

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

REGRANEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: REGRANEX

Introduction

REGRANEX (becaplermin) is a biologic drug used for the treatment of diabetic foot ulcers, particularly those that are neuropathic. It is the only FDA-approved drug of its kind, utilizing a platelet-derived growth factor (PDGF) to promote wound healing. Here, we delve into the market dynamics and financial trajectory of REGRANEX.

Market Dominance and Competition

The diabetic foot ulcer treatment market is predominantly driven by off-label generic drugs such as analgesics and anti-infectives, which capture around 78% of the current market. However, REGRANEX stands out as the sole FDA-approved biologic for this indication[1].

Regulatory Approval and Clinical Use

Approved by the US FDA in December 1997, REGRANEX gel is formulated to act as a first-line treatment following effective ulcer care. It contains becaplermin, a recombinant human platelet-derived growth factor (rhPDGF-BB), which promotes the chemotactic recruitment and proliferation of cells involved in wound repair and enhances the formation of granulation tissue[4].

Pricing and Revenue

REGRANEX is sold at a significant price point, with each package (15 g) costing approximately $560 to $1,000. This pricing reflects the complex nature of biologic drugs and the limited competition in the market for FDA-approved treatments for diabetic foot ulcers[5].

Market Size and Growth

The diabetic foot ulcer treatment market is projected to grow at a CAGR of 17.0% during the study period of 2018-2030. This growth is driven by increasing prevalence of diabetes, advancements in wound care technologies, and the need for effective treatments. REGRANEX, being a pioneering product in this space, is well-positioned to capitalize on this growth[1].

Financial Performance of Key Players

Companies like Smith+Nephew, which operate in the broader wound care market, have shown strong financial performance. For instance, Smith+Nephew's Advanced Wound Management franchise has delivered above-market performance since 2021, driven by extensive work to improve commercial execution and a strong portfolio. While REGRANEX is not specifically mentioned in Smith+Nephew's financial reports, the overall growth in the wound care segment indicates a favorable market environment[2].

Challenges and Risks

Despite its market position, REGRANEX faces several challenges. One significant concern is the increased rate of mortality secondary to malignancy observed in patients treated with three or more tubes of REGRANEX Gel. This has led to cautionary recommendations and potential limitations in its use, especially in patients with known malignancies[4].

Biosimilar Competition

The entry of biosimilars, or follow-on biologics (FOBs), could potentially impact REGRANEX's market share. However, the extent of this impact is uncertain due to factors such as high fixed costs of entry, limited perceived substitutability between innovator biologics and FOBs, and structural limitations in the distribution system. Studies suggest that FOBs may capture a market share of 10% to 45% over the longer term, but this is highly dependent on various regulatory, scientific, and clinical factors[3].

Clinical Efficacy and Safety

REGRANEX has shown efficacy in promoting wound healing, but its safety profile includes risks such as increased mortality from systemic malignancies. Clinical studies and post-marketing surveillance have highlighted these risks, necessitating careful patient selection and monitoring[4].

Market Potential and Future Outlook

Given the growing demand for effective treatments for diabetic foot ulcers and the limited competition in FDA-approved biologics, REGRANEX is poised for continued market presence. However, the market potential is influenced by the emergence of new treatments, biosimilars, and the ongoing need to manage the drug's safety profile.

Financial Trajectory

The financial trajectory of REGRANEX is tied to the overall growth of the diabetic foot ulcer treatment market and the performance of its parent company. With a strong pricing strategy and a dominant market position, REGRANEX is likely to continue generating significant revenue. However, the impact of potential biosimilars and the need for ongoing safety monitoring will be critical factors in its long-term financial performance.

Key Takeaways

• Market Dominance: REGRANEX is the only FDA-approved biologic for diabetic foot ulcer treatment.
• Pricing: Sold at $560 to $1,000 per package, reflecting its complex biologic nature.
• Growth Potential: The diabetic foot ulcer treatment market is projected to grow at a CAGR of 17.0% from 2018 to 2030.
• Challenges: Faces risks related to increased mortality from malignancies and potential biosimilar competition.
• Clinical Efficacy: Promotes wound healing but requires careful patient selection and monitoring.

FAQs

What is REGRANEX used for?

REGRANEX (becaplermin) is used for the treatment of diabetic foot ulcers, particularly those that are neuropathic.

How much does REGRANEX cost?

Each package (15 g) of REGRANEX costs approximately $560 to $1,000.

Is REGRANEX the only FDA-approved drug for diabetic foot ulcers?

Yes, REGRANEX is the only FDA-approved biologic for the treatment of diabetic foot ulcers.

What are the potential risks associated with REGRANEX?

REGRANEX has been associated with an increased rate of mortality secondary to malignancy in patients treated with three or more tubes.

How does the emergence of biosimilars impact REGRANEX?

The impact of biosimilars on REGRANEX is uncertain but could potentially reduce its market share over the longer term due to various regulatory and clinical factors.

Sources

1. Diabetic Foot Ulcer Treatment Market Expected to Witness a High Jump as the Market is Projected to Grow with a CAGR of 17.0 During the Study Period 2018-2030 - DelveInsight.
2. Smith+Nephew Fourth Quarter and Full Year 2022 Results - Smith+Nephew.
3. The Effect on Federal Spending of Legislation Creating a Regulatory Pathway for Follow-on Biologics - Duke University.
4. REGRANEX Gel Label - FDA.
5. Annual Report - Cision.