AMEVIVE Drug Profile

Summary for Tradename: AMEVIVE

High Confidence Patents:	18
Applicants:	1
BLAs:	1

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 AMEVIVE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for AMEVIVE 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
Astellas Pharma Us, Inc.	AMEVIVE	alefacept	For Injection	125036	4,956,281	2007-06-03	DrugPatentWatch analysis and company disclosures
Astellas Pharma Us, Inc.	AMEVIVE	alefacept	For Injection	125036	5,547,853	2012-10-21	DrugPatentWatch analysis and company disclosures
Astellas Pharma Us, Inc.	AMEVIVE	alefacept	For Injection	125036	5,719,047	2015-05-15	DrugPatentWatch analysis and company disclosures
Astellas Pharma Us, Inc.	AMEVIVE	alefacept	For Injection	125036	5,728,677	2015-06-02	DrugPatentWatch analysis and company disclosures
Astellas Pharma Us, Inc.	AMEVIVE	alefacept	For Injection	125036	5,814,316	2015-09-29	DrugPatentWatch analysis and company disclosures
Astellas Pharma Us, Inc.	AMEVIVE	alefacept	For Injection	125036	5,837,854	2016-04-05	DrugPatentWatch analysis and company disclosures
Astellas Pharma Us, Inc.	AMEVIVE	alefacept	For Injection	125036	5,914,111	2015-06-02	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for AMEVIVE 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
Astellas Pharma Us, Inc.	AMEVIVE	alefacept	For Injection	125036	10,111,968	2036-08-10	Patent claims search
Astellas Pharma Us, Inc.	AMEVIVE	alefacept	For Injection	125036	10,182,561	2036-06-14	Patent claims search
Astellas Pharma Us, Inc.	AMEVIVE	alefacept	For Injection	125036	10,261,083	2034-01-03	Patent claims search
Astellas Pharma Us, Inc.	AMEVIVE	alefacept	For Injection	125036	10,267,754	2034-04-11	Patent claims search
Astellas Pharma Us, Inc.	AMEVIVE	alefacept	For Injection	125036	10,329,314	2038-02-28	Patent claims search
Astellas Pharma Us, Inc.	AMEVIVE	alefacept	For Injection	125036	10,428,059	2037-10-06	Patent claims search
Astellas Pharma Us, Inc.	AMEVIVE	alefacept	For Injection	125036	10,487,098	2039-03-19	Patent claims search

International Patents for AMEVIVE

Country	Patent Number	Estimated Expiration
Australia	660981
Japan	H02501113
European Patent Office	0503648
Japan	2003089654
Japan	3520272
Spain	2147178
Mexico	9203138

Supplementary Protection Certificates for AMEVIVE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C00607332/01	Switzerland		PRODUCT NAME: ALEFACEPT; REGISTRATION NUMBER/DATE: SWISSMEDIC 56144 02.06.2004

Market Dynamics and Financial Trajectory for AMEVIVE

Last updated: April 7, 2026

What Is the Current Market Position of AMEVIVE?

AMEVIVE (alefacept), a biologic for the treatment of chronic plaque psoriasis, was developed by Biogen and appears on the market with limited penetration. Its primary mechanism involves a fusion protein targeting CD11a, part of LFA-1, to inhibit T-cell activation. The drug has not achieved significant market share against established biologics like Humira or Cosentyx.

In 2021, sales of AMEVIVE remained minimal, estimated at under $10 million globally, according to industry reports. The drug's market presence is confined mainly to niche segments, including patients resistant to other treatments or with contraindications.

What Are the Key Market Factors Influencing AMEVIVE?

Regulatory and Approval Landscape

• FDA Approval: Received approval in 2003 for psoriasis. No recent announcements of new indications or label expansions.
• Market Exclusivity & Patent Position: Patent protection extends until approximately 2025, with potential for extensions via regulatory exclusivities.

Competition from Other Biologics

• Market Leaders: Humira (adalimumab) led the psoriasis biologic market with global sales exceeding $20 billion in 2022.
• Generic and Biosimilar Impact: Biosimilars for humira entered the market in the U.S. post-2023, pressuring prices and reducing overall biologic revenues.

Pricing and Reimbursement

• Pricing: List price historically positioned at similar levels to other biologics ($30,000 to $45,000 annually per patient).
• Reimbursement Trends: Payor resistance is rising for less proven or less differentiated biologics, especially with biosimilars reducing overall market prices.

Market Demand & Usage Patterns

• Patient Segments: Primarily moderate-to-severe psoriasis cases.
• Physician Prescribing Habits: Favor established biologics with extensive clinical data and higher market penetration.

What Is the Financial Trajectory for AMEVIVE?

Revenue Forecast

• Historical Revenue: Under $10 million in 2021.
• Projected Revenue: Unless new indications or formulations emerge, sales are expected to decline due to biosimilar competition and market saturation.
• Market Potential: Limited to niche patient subsets; upward growth expectations are low, barring significant approval or label expansion.

Cost Structure and Profitability

• Development and Manufacturing: Biogen reported high R&D costs for biologics, with manufacturing expenses remaining high due to complex production processes.
• Profit Margins: Likely negative or minimal given low sales volumes and high fixed costs.

Licensing and Partnership Prospects

• No recent indications of licensing deals or partnerships. The drug's limited market appeal constrains these opportunities.

Key Market Trends Impacting AMEVIVE’s Future

• Biosimilar proliferation for primary competitors.
• Increasing adoption of oral small-molecule therapies for psoriasis.
• Efforts by payors to restrict biologic drug spending, favoring cost-effective options.
• Slow-paced innovation in the specific mechanism of alefacept compared to newer biologics.

Summary of Market and Financial Outlook

Aspect	Status	Impact on AMEVIVE
Market share	Low, stagnant	Limited revenue growth potential
Competition	Intensifies	Declines in sales expected without differentiation
Patent expiration	2025	Risk of generic/biosimilar entry
Revenue forecast	Flat or declining	Marginal contribution beyond current levels
Profitability	Questionable	High manufacturing costs versus low sales volume

Key Takeaways

• AMEVIVE operates within a mature, highly competitive biologic market for psoriasis.
• Biosimilar competition and market saturation hinder sales growth.
• Limited revenues and high costs make long-term profitability unlikely without strategic shifts.
• Patent expiration in 2025 poses a threat of generic/biosimilar entry, further reducing revenues.
• Market trends favor newer biologics and oral therapies, challenging AMEVIVE's relevance.

FAQs

1. How does AMEVIVE compare to other psoriasis biologics in efficacy?
It has demonstrated comparable efficacy in clinical trials but lacks the extensive real-world data that supports the use of more established biologics.

2. What are the primary barriers to increasing sales of AMEVIVE?
Major barriers include competition from more effective or better-known biologics, biosimilars, and a lack of recent label expansion.

3. Are there any plans for new indications for AMEVIVE?
No public plans have been announced. The focus appears to be on maintaining current status, with no indication of upcoming clinical trials.

4. What is the likelihood of AMEVIVE maintaining market exclusivity beyond 2025?
Patent extensions are unlikely as the original patents expire around 2025, increasing exposure to biosimilar competition.

5. Can AMEVIVE benefit from combination therapy protocols?
Currently, there is no evidence or regulatory approval supporting combination use, limiting potential demand.

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References

[1] U.S. Food and Drug Administration. (2003). AMEVIVE (alefacept) approval letter.
[2] Evaluate Pharma. (2022). Top biologic drugs by sales.
[3] Drug Channels Institute. (2023). Biosimilar market entry impacts.