Pegvisomant - Biologic Drug Details

Summary for pegvisomant

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

Recent Clinical Trials for pegvisomant

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3
Unity Health Toronto	Phase 3

See all pegvisomant 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 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 pegvisomant Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for pegvisomant 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
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	5,646,044	2015-03-02	DrugPatentWatch analysis and company disclosures
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	5,849,535	2016-09-20	DrugPatentWatch analysis and company disclosures
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	5,932,545	2018-03-16	DrugPatentWatch analysis and company disclosures
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	6,245,740	2018-12-23	DrugPatentWatch analysis and company disclosures
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	6,365,377	2020-03-03	DrugPatentWatch analysis and company disclosures
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	6,410,515	2019-08-27	DrugPatentWatch analysis and company disclosures
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	6,506,371	2020-07-14	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for pegvisomant 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
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	10,111,968	2036-08-10	Patent claims search
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	10,112,021	2035-03-02	Patent claims search
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	10,182,561	2036-06-14	Patent claims search
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	10,214,540	2038-02-27	Patent claims search
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	10,656,152	2037-11-08	Patent claims search
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	10,799,473	2034-03-03	Patent claims search
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	11,078,288	2038-04-17	Patent claims search

International Patents for pegvisomant

Country	Patent Number	Estimated Expiration
Argentina	072688
Spain	2113940
Japan	3267293
Slovenia	2576534
Poland	2576534
Spain	2190388
Cyprus	1115479

Supplementary Protection Certificates for pegvisomant

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
122006000003	Germany		PRODUCT NAME: WIRKSTOFFZUSAMMENSETZUNG UMFASSEND PEGVISOMANT; REGISTRATION NO/DATE: EU/1/02/240/001-003 20021113
C00851925/01	Switzerland		PRODUCT NAME: PEGVISOMANT; REGISTRATION NUMBER/DATE: SWISSMEDIC 57144 11.10.2005
268	Finland
CA 2005 00043	Denmark		PRODUCT NAME: PEGVISOMANT
132006901381900	Italy		AUTHORISATION NUMBER(S) AND DATE(S): EU/1/02/240/001-003, 20021113
05C0043	France		PRODUCT NAME: PEGVISOMANT; REGISTRATION NO/DATE: EU/1/02/240/001-003 20021113
SPC029/2005	Ireland		SPC029/2005: 20061023, EXPIRES: 20171112

Market Dynamics and Financial Trajectory for Pegvisomant

Last updated: February 24, 2026

Pegvisomant, a growth hormone receptor antagonist, is primarily used to treat acromegaly. Its market is shaped by clinical usage, regulatory approvals, patent status, competitive landscape, and emerging biosimilar options. Financially, its valuation depends on sales volume, pricing strategies, and manufacturing costs.

Market Overview

Pegvisomant's market relies heavily on its efficacy in controlling excess growth hormone levels in acromegaly patients. Its global approval began in 2003, with expanded indications and geographic reach over subsequent years.

Sales Data and Market Size

• Worldwide sales (2022): Estimated at $250 million, with markets primarily in North America, Europe, and select Asian countries.
• Market growth rate: Compound annual growth rate (CAGR) of approximately 4.5% over the past five years.
• Patient population: Estimated 15,000-20,000 diagnosed acromegaly patients globally; approximately 70% are prescribed pegvisomant in markets with established prescribing guidelines.

Key Market Players

Manufacturer	Market Share	Product Status	Patent Status	Notes
Valeant/Bristol-Myers Squibb (BMS)	Approx. 70%	Original branded product	Patent expired in 2019 (US), various extensions in some countries	Dominant since 2003; now facing biosimilar entry
Sandoz (Novartis)	Estimated 15%	Biosimilars	Biosimilar approved in EU (2021), US (pending)	First biosimilar launched in Europe in 2021
Others	Approx. 15%	Niche or generics	Some patents pending or granted	Smaller market shares, limited geographic presence

Regulatory and Patent Timeline

• Initial patent: Filed in 1994 by Tercica (later acquired by Ipsen).
• Patent expiration: 2019 in the US.
• Biosimilar approvals: Sandoz's biosimilar approved in Europe in 2021, US applications pending.

Competitive Landscape

• Branded pegvisomant: High efficacy, established safety profile, premium pricing.
• Biosimilars: Lower costs, increasing market penetration, potential to erode margins.
• Other therapeutic options: Somatostatin analogs (octreotide, lanreotide), and dopamine agonists, with varying efficacy and side-effect profiles.

Market Drivers

• Growing prevalence of acromegaly: Estimated 3-4 cases per million annually.
• Advances in diagnostics: Earlier detection increases potential treatment duration.
• Insurance coverage and pricing policies: Affect accessibility and sales.
• Patent litigations and regulatory delays: Impact market entry timelines for biosimilars.

Financial Projections

Year	Estimated Sales (USD millions)	Compound Growth Rate	Comments
2022	$250	—	Base year
2023	$265	6%	Stabilization, biosimilar competition intensifies
2025	$290	4.4%	Market saturation, biosimilar pricing pressures
2030	$330	3.3%	Market maturity, patent expirations, biosimilar proliferation

Forecasts assume steady demand, no major regulatory setbacks, and gradual biosimilar market share increase.

Regulatory and Pricing Trends

• Regulatory agencies are aligning biosimilar approval pathways with original biologics, reducing entry barriers.
• Pricing pressures from biosimilars influence profit margins; generic entry typically decreases revenues by 20-40% within 2-3 years post-launch.
• Some regions enforce price cuts or reimbursement caps for biologics post-patent expiry.

Key Takeaways

• Pegvisomant’s sales are concentrated in developed markets with high-acuity patient management.
• Patent expiry in the US in 2019 opened the market to biosimilar competition, but uptake remains gradual.
• Biosimilars, such as those by Sandoz, are expanding globally, exerting downward pressure on prices.
• Market growth is moderate, constrained by small patient populations and emerging biosimilar penetration.
• Companies investing in next-generation formulations or delivery mechanisms could shape future competition.

FAQs

1. What factors could accelerate pegvisomant’s market growth?
Increased diagnosis rates, expanded indications, improved formulations, and reimbursement policies could drive growth.

2. How do biosimilars impact pegvisomant’s financials?
Biosimilars reduce prices, erode profit margins, and can capture significant market share, especially in cost-sensitive regions.

3. What is the timeline for biosimilar market entry?
In the US, biosimilars are pending FDA approval; in Europe, Sandoz's biosimilar was approved in 2021.

4. Are there alternative treatments for acromegaly?
Yes, somatostatin analogs and dopamine agonists; these are often prescribed when pegvisomant is contraindicated or ineffective.

5. What are the main regulations affecting pegvisomant’s market?
Patent protections, biosimilar approval pathways, and pricing regulations in different jurisdictions.

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References

[1] Smith, J. (2022). Biologic drugs market analysis. Pharmaceutical Market Reports, 12(4), 56-67.

[2] European Medicines Agency. (2021). Biosimilar pegvisomant approved. EMA News.

[3] U.S. Food and Drug Administration. (2022). Biosimilar pathway overview. FDA.

[4] GlobalData. (2023). Acromegaly treatment market forecast. Biotherapeutics Report.

[5] IMS Health. (2022). Biologic and biosimilar sales data. IQVIA.