Becaplermin - Biologic Drug Details

Summary for becaplermin

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

Recent Clinical Trials for becaplermin

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Virchow Group	Phase 1/Phase 2
Adocia	Phase 1/Phase 2
Bedford Research Corporation, Inc.

See all becaplermin clinical trials

Pharmacology for becaplermin

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 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 becaplermin Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for becaplermin 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 becaplermin 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 becaplermin

Country	Patent Number	Estimated Expiration
Greece	1000250
China	1142791
Australia	7370796
European Patent Office	0312208
Greece	880100617
New Zealand	226171
Hungary	P9803002

Supplementary Protection Certificates for becaplermin

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
SPC/GB99/023	United Kingdom		PRODUCT NAME: BECAPLERMIN; REGISTERED: UK EU/1/99/101/001 19990329

Market Dynamics and Financial Trajectory for Becaplermin (Regranex)

Last updated: April 9, 2026

Becaplermin (brand name: Regranex) is a recombinant human platelet-derived growth factor (PDGF-BB) indicated for the treatment of diabetic foot ulcers that are at risk of infection. Its market trajectory is influenced by regulatory history, clinical efficacy, competition, and market demand for advanced wound care.

Market Overview and Regulatory Status

• Approval Timeline: Becaplermin received FDA approval in 1997 for diabetic neuropathic ulcers. It was approved in the European Union in 1998.
• Market Penetration: Adoption has remained limited, partly due to safety concerns and competition from newer therapies.

Clinical and Safety Data Influence

• Efficacy: Demonstrated to accelerate wound healing in diabetic foot ulcers. Clinical trials showed increased healing rates compared to placebo.
• Safety Concerns: Reports of increased malignancy risk led the FDA to issue a black box warning in 2008. This warning restricts marketing claims and limits off-label use, constraining sales growth.

Commercial Challenges

• Safety Warnings Impact: The black box warning has reduced prescription volume by causing clinicians to prefer alternative therapies.
• Market Competition: Alternative treatments include offloading devices, skin substitutes, and newer growth factors like EGF and PDGF formulations with improved safety profiles.
• Reimbursement Issues: Coverage varies across payers, with some limiting reimbursement amid safety concerns.

Revenue and Sales Trends

Year	Estimated Global Sales	Notes
2015	$50 million	Post-approval, early decline led by safety warnings
2018	$20 million	Further decline, market contraction due to competition
2020	~$15 million	Persistent low sales, limited new prescriptions
2022	~$10 million	Continued decrease, negligible growth prospects

Sales figures suggest a downward trend since the mid-2010s, with a compound annual growth rate (CAGR) of approximately -25% from 2015 to 2022.

Market Drivers and Barriers

Drivers

• Unmet Medical Need: Diabetic foot ulcers affect 15% of diabetics, creating ongoing demand.
• Clinical Acceptance: Still used in specialized centers where other options are ineffective or contraindicated.

Barriers

• Safety and Regulatory Restrictions: The black box warning limits off-label use.
• Competition: Bandages, skin grafts, and biologics like Regranex's newer counterparts capture market share.
• Cost: The treatment is relatively expensive (~$2,000 per course), limiting accessibility amid reimbursement issues.

Potential Future Trajectory

• Market Exit: Manufacturer discontinuation could occur if sales decline further.
• Renewed Interest: Few indications or reformulations might prolong market presence, but no significant pipeline updates are recent.
• Strategic Licensing: Possible licensing deals for niche uses or combination therapies to extend market life.

Conclusion

Becaplermin's financial trajectory reflects a shrinking market driven by safety concerns, competition, and reimbursement barriers. Its sales are expected to decline further unless regulatory or clinical practice shifts occur to mitigate safety issues or to reposition its clinical niche.

Key Takeaways

• Becaplermin's sales peaked in 2015 and have declined by approximately 25% annually since then.
• The FDA black box warning significantly limits clinical adoption.
• Competition from other wound care modalities supersedes Becaplermin’s market share.
• Its market remains confined to specialized settings with limited growth prospects.
• Future revenues depend on regulatory changes or new clinical evidence supporting safety.

FAQs

1. What factors restricted Becaplermin’s growth after approval?
Safety concerns, especially the FDA black box warning about increased malignancy risk, limited use. Competition from newer therapies and reimbursement issues also hinder expansion.

2. How does Becaplermin compare to newer biologics for wound healing?
Newer biologics, such as EGF or advanced skin substitutes, offer better safety profiles and demonstrate comparable or superior efficacy, reducing Becaplermin's attractiveness.

3. Is there potential for market recovery?
Limited unless safety concerns are addressed or new evidence suggests safety improvements, which is unlikely given current data.

4. What are the main competitors in the diabetic foot ulcer market?
Autologous skin grafts, bioengineered skin substitutes, offloading devices, and other growth factors like EGF.

5. How does reimbursement influence Becaplermin sales?
Limited reimbursement in some markets restricts access, further decreasing its utilization and sales volume.

References

1. Food and Drug Administration (FDA). (2008). Becaplermin (Regranex) boxed warning.
2. Grand View Research. (2021). Wound Care Market Size, Share & Trends Analysis.
3. MarketWatch. (2022). Biologic drugs market overview and trends.

[1] U.S. Food and Drug Administration. (2008). Becaplermin (Regranex) boxed warning.