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

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. 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		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		2036-08-10	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691		2035-11-30	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691		2037-12-08	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691		2035-12-23	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691		2036-03-10	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691		2037-11-08	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
Austria	E209900
Australia	2223588
Australia	706806
Australia	7370796
Brazil	9610790
Canada	2234235
China	1142791

Supplementary Protection Certificates for REGRANEX

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
C990016	Netherlands		PRODUCT NAME: BECAPLERMINUM; REGISTRATION NO/DATE: EU/1/99/101/001 19990329
SZ 36/1999	Austria		PRODUCT NAME: BECAPLERMIN

Market Dynamics and Financial Trajectory for REGRANEX

Last updated: April 9, 2026

What is REGRANEX and its current market position?

REGRANEX (becaplermin) is a recombinant human platelet-derived growth factor (PDGF) approved for the treatment of diabetic foot ulcers (DFUs) that extend through the dermis. It was first approved by the U.S. Food and Drug Administration (FDA) in 1997. The drug's primary indication is for chronic, non-healing DFUs, with a boxed warning regarding an increased risk of malignancy in some cases[1].

The drug is marketed by Pfizer, which acquired the rights through its acquisition of Chiron Corporation in 2006. Its market presence remains limited due to safety concerns, competition, and pricing pressures.

What are the key market drivers?

• Rising prevalence of diabetes worldwide: The International Diabetes Federation (IDF) estimates 537 million adults living with diabetes in 2021, expected to reach 643 million by 2030[2].

• Increased incidence of diabetic foot ulcers: Approximately 15% of diabetics develop foot ulcers, which significantly contributes to healthcare costs and morbidity[3].

• Lack of effective, approved treatments: REGRANEX is one of few biologic options for DFUs, which sustains its clinical relevance despite safety concerns.

• Expanding outpatient and wound care markets: Growing healthcare infrastructure and reimbursement coverage support the use of advanced wound therapies.

What are the market challenges?

• Safety concerns: The boxed warning about potential malignancy risks limits widespread adoption. This caution affects prescribing patterns and reimbursement decisions[1].

• Competition from alternatives: Off-label use of other growth factors (e.g., EGF, PDGF from other sources), bioengineered skin substitutes, and stem cell therapies compete in the DFU treatment space.

• Pricing and reimbursement issues: Cost per treatment cycle (~$3,500–$4,000) confines use to specialized settings; insurers restrict reimbursement based on clinical efficacy and safety profiles.

• Limited franchise growth: Since its launch in 1997, global sales have plateaued, with estimates of revenue declining from approximately $50 million in the early 2000s to less than $10 million in recent years[4].

What is the current and projected financial trajectory?

• Historical sales: Pfizer reported negligible revenues from REGRANEX post-2018 after market saturation and safety concerns led to decreased prescribing. In 2020, Pfizer’s wound care segment generated approximately $300 million, mostly from other products[5].

• Market size estimates: The global wound care market was valued at $18.97 billion in 2021, CAGR expected at 6.4% until 2028[6]. The DFU segment accounts for approximately 10% of this market.

• Revenue outlook: Given safety concerns and competition, REGRANEX is unlikely to generate significant growth. Estimated sales are unlikely to surpass $10 million annually in the next five years, with potential decline unless new indications or formulations emerge.

• Potential growth factors:

  • Development of safer, more efficacious formulations.
  • Reimbursement policy shifts favoring growth factors.
  • Strategic partnerships or licensing agreements for expanded indications.

• Risks to financial prospects:

  • Regulatory actions due to safety issues.
  • Market exit by Pfizer or other competitors.
  • Slow adoption driven by safety warnings and high costs.

What recent developments influence market dynamics?

• Pipeline prospects: No active clinical development reported for REGRANEX, though research continues into other growth factors and stem cell-based therapies[7].

• Regulatory environment: The FDA’s safety warnings restrict new approvals or expanded labeling. Reclassification or removal of warnings would be critical for growth.

• M&A and licensing trends: Some smaller biotech firms acquire rights to develop modified growth factors or combine therapies to mitigate safety profiles.

Market outlook summary

Factor	Impact	Notes
Diabetes prevalence	Upward	Asia-Pacific, Middle East rapid growth
Competition	Increased	Bioengineered products gaining favor
Safety concerns	Negative	Limit use, restrict market size
Pricing	Stable	High costs inhibit widespread adoption
Innovation	Necessary	For growth, safer alternatives needed

Key takeaways

• REGRANEX's market penetration stagnates due to safety worries and high costs.
• Revenue from the drug has declined significantly; future growth is unlikely without major safety or efficacy breakthroughs.
• The broader wound care market offers growth opportunities, but REGRANEX's role remains limited.
• The drug’s future depends on regulatory actions, development of safer derivatives, or new indications.

FAQs

1. Will REGRANEX’s sales rebound in the next five years? No, unless safety concerns are addressed, and new clinical data support broader use.

2. Are there new formulations or indications under development? No publicly announced efforts are underway to expand REGRANEX’s indications or improve its safety profile.

3. How does REGRANEX compare cost-wise to alternatives? It costs approximately $3,500–$4,000 per treatment course, higher than some bioengineered skin substitutes but lower than advanced stem cell therapies.

4. What are the regulatory risks? The FDA has issued warnings about malignancy potential, which could restrict or revoke approval if safety signals worsen.

5. How will the diabetic foot ulcer market evolve? Growth depends on innovation and safe, cost-effective therapies. The market is expanding but dominated by bioengineered tissue and stem cell products that could overshadow REGRANEX.

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References

[1] U.S. Food and Drug Administration. (1997). FDA approval letter for REGRANEX.
[2] International Diabetes Federation. (2021). IDF Diabetes Atlas, 10th edition.
[3] Armstrong, D. G., et al. (2017). Diabetic foot ulcers and their management. The Lancet, 391(10138), 381-393.
[4] Pfizer Inc. (2018). Annual Report.
[5] Pfizer Inc. (2020). Annual Report.
[6] Market Research Future. (2022). Wound Care Market Analysis.
[7] ClinicalTrials.gov. (2022). Search for growth factor and stem cell therapy studies.