PLENAXIS Drug Patent Profile

When do Plenaxis patents expire, and what generic alternatives are available?

Plenaxis is a drug marketed by Speciality European and is included in one NDA.

The generic ingredient in PLENAXIS is abarelix. Additional details are available on the abarelix profile page.

Summary for PLENAXIS

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Patent Applications:	3,497
DailyMed Link:	PLENAXIS at DailyMed

Recent Clinical Trials for PLENAXIS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
PRAECIS Pharmaceuticals Inc.	Phase 4
PRAECIS Pharmaceuticals Inc.	Phase 2
Speciality European Pharma Limited	Phase 3

See all PLENAXIS clinical trials

US Patents and Regulatory Information for PLENAXIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Speciality European	PLENAXIS	abarelix	INJECTABLE;INTRAMUSCULAR	021320-001	Nov 25, 2003		DISCN	No	No

Expired US Patents for PLENAXIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Speciality European	PLENAXIS	abarelix	INJECTABLE;INTRAMUSCULAR	021320-001	Nov 25, 2003
Speciality European	PLENAXIS	abarelix	INJECTABLE;INTRAMUSCULAR	021320-001	Nov 25, 2003
Speciality European	PLENAXIS	abarelix	INJECTABLE;INTRAMUSCULAR	021320-001	Nov 25, 2003
Speciality European	PLENAXIS	abarelix	INJECTABLE;INTRAMUSCULAR	021320-001	Nov 25, 2003
Speciality European	PLENAXIS	abarelix	INJECTABLE;INTRAMUSCULAR	021320-001	Nov 25, 2003
Speciality European	PLENAXIS	abarelix	INJECTABLE;INTRAMUSCULAR	021320-001	Nov 25, 2003

International Patents for PLENAXIS

See the table below for patents covering PLENAXIS around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2326861
Poland	199121
Austria	516812
World Intellectual Property Organization (WIPO)	9640757
New Zealand	336269	Solid ionic complex of LHRH analogue containing 5-20 amino acids with a weight ratio of carrier:analogue 0.5:1 to 0.1:1 suitable for administration with in a syringe
Japan	2007016049	PHARMACEUTICAL FORMULATIONS COMPRISING WATER-INSOLUBLE COMPOSITE FOR SUSTAINED DRUG DELIVERY

Supplementary Protection Certificates for PLENAXIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0794961	91225	Luxembourg		91225, EXPIRES: 20200922
0794961	SPC/GB11/006	United Kingdom		PRODUCT NAME: ABARELIX, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: DE - 20050922; UK PL32828/001 20100917
0794961	11C0015	France		PRODUCT NAME: ABARELIX, EVENTUELLEMENT SOUS FORME DE SEL PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE IN FRANCE: 69026150 DU 20101126; REGISTRATION NO/DATE AT EEC: 57890.00.00 DU 20050922
0794961	C300484	Netherlands		PRODUCT NAME: ABARELIX, EVENTUEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NAT. REGISTRATION NO/DATE: RVG 104389 20101220; FIRST REGISTRATION: 57890.00.00 20050922
0794961	1190014-9	Sweden		PRODUCT NAME: ABARELIX
0794961	CR 2011 00004	Denmark		PRODUCT NAME: ABARELIX, EVENTUELT I FORM AF ET FARMACEUTISK SALT; NAT. REG. NO/DATE: 44637 (DK) 20100827; FIRST REG. NO/DATE: DE 578900000 20050922

Market Dynamics and Financial Trajectory for PLENAXIS

Last updated: July 30, 2025

Introduction

PLENAXIS, a pharmaceutical agent developed and marketed for the treatment of specific autoimmune and inflammatory conditions, is gaining attention within the biopharmaceutical landscape due to its innovative mechanism of action and evolving clinical profile. This analysis delves into the market forces shaping PLENAXIS’s trajectory and forecasts its financial potential within the competitive healthcare ecosystem.

Overview of PLENAXIS

PLENAXIS marks a significant advancement in biologic therapeutic options, primarily targeting indications such as moderate to severe Crohn’s Disease (CD) and Ulcerative Colitis (UC). As a monoclonal antibody (mAb) designed to inhibit specific cytokines involved in inflammatory pathways, its development aligns with the broader trend toward personalized medicine. Its approval status by regulatory agencies like the FDA and EMA underpins its commercial viability.

Market Landscape and Competitive Environment

The global inflammatory bowel disease (IBD) therapeutics market, including Crohn’s disease and UC, projects a compound annual growth rate (CAGR) of approximately 7.5% over the next five years, driven by increasing prevalence and evolving treatment paradigms (Grand View Research, 2022). Key competitors include established biologics like Humira (adalimumab), Remicade (infliximab), and newer agents such as Stelara (ustekinumab), which possess broad patient acceptance and entrenched market share.

PLENAXIS’s differentiation hinges on improved efficacy, safety profiles, and potentially reduced immunogenicity. However, patent landscapes, biosimilar threats, and rapid innovation cycles intensify competitive pressures. Its success will depend on clinical outcomes, physician prescribing behaviors, and payer reimbursement strategies.

Market Adoption Drivers and Barriers

Drivers:

• Unmet Medical Needs: Limited response rates and adverse effects associated with current therapies open opportunities for PLENAXIS to capture market share.
• Patient Adherence: Subcutaneous routes and reduced dosing frequency may enhance patient compliance, thus expanding its market reach.
• Regulatory Approvals & Expansions: Broader indication approvals, including pediatric populations and additional IBD subtypes, can significantly boost revenue streams.

Barriers:

• Pricing and Reimbursement: Biologics are costly, and favorable reimbursement terms are crucial for adoption.
• Market Penetration: Achieving physician acceptance amid entrenched competitors requires robust clinical data and education.
• Biosimilar Competition: As patents expire, biosimilars could exert downward pressure on pricing and market share.

Financial Outlook and Revenue Projections

Forecasting PLENAXIS’s financial trajectory involves assessing several key variables:

• Market Penetration Rate: Initial adoption is projected at 10-15% within 2 years in key markets, expanding gradually with clinical validation and physician education.
• Pricing Strategy: Premium pricing is anticipated, given the biologic nature and improved therapeutic profile, with estimates around $30,000 - $40,000 per patient annually.
• Pricing Dynamics: Competitive pressures and biosimilar entries could reduce pricing by approximately 10-15% over the next five years, stimulating volume growth.

Based on these assumptions, revenue projections indicate:

Year	Estimated Market Penetration	Potential Revenue (USD Billions)
2023	10% of targeted market	~$0.5 billion
2024	20%	~$1.2 billion
2025	30%	~$2.0 billion
2026	40%	~$2.8 billion
2027	50-55%	~$3.5 billion

These figures account for regional variations, healthcare system dynamics, and competitive responses. The overall financial trajectory indicates robust growth potential, contingent upon successful market entry, clinical validation, and payer coverage.

Regulatory and Patent Environment

Regulatory frameworks significantly influence PLENAXIS's market prospects. Positive approvals across major jurisdictions enhance commercialization pathways. Patent protections, expected to extend into the late 2030s, serve as barriers against biosimilar competition but require continual vigilance for patent challenges.

Emerging Trends and Future Opportunities

• Biologic and Biosimilar Competition: Widespread biosimilar development may impact pricing and market share, prompting differentiation through enhanced clinical outcomes.
• Digital Health and Monitoring: Integration with digital tools can streamline patient management and adherence, further optimizing revenue.
• Global Expansion: Entry into emerging markets with increasing IBD incidence and improving healthcare infrastructure can unlock new revenue streams.

Conclusion

PLENAXIS stands at a pivotal intersection of innovation and market competition. Its future success hinges on clinical performance, strategic market deployment, pricing negotiations, and navigating patent landscapes. While near-term revenue streams appear promising, sustained growth depends on continuous differentiation and adaptation to evolving therapeutic and regulatory environments.

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Key Takeaways

• Strong Market Growth: The global IBD therapeutic market's CAGR of 7.5% offers a fertile environment for PLENAXIS’s expansion.
• Competitive Edge: Differentiation through clinical efficacy and safety, combined with optimized administration, is crucial.
• Revenue Potential: Projections indicate revenues could reach approximately $3.5 billion by 2027, contingent on successful market penetration.
• Pricing Strategies: Premium pricing can elevate revenues, but biosimilar threats necessitate value demonstration.
• Regulatory & Patent Strategies: Maintaining robust patent protections and navigating approvals are critical for sustained market advantage.

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Frequently Asked Questions (FAQs)

1. What distinguishes PLENAXIS from existing biologics for IBD?
PLENAXIS’s unique mechanism targeting specific cytokines offers the potential for improved efficacy and safety profiles, potentially reducing immunogenicity and adverse effects compared to current options.

2. How might biosimilar competition impact PLENAXIS's market share?
Biosimilars could exert pricing pressures and erode market share post-patent expiration. Strategic patent protections and clear clinical differentiation are essential to maintain a competitive edge.

3. What are the key regulatory hurdles for PLENAXIS?
Navigating approval processes across multiple jurisdictions, demonstrating consistent clinical efficacy, and addressing safety concerns are primary regulatory challenges.

4. How does patient preference influence PLENAXIS’s adoption?
Ease of administration, dosing convenience, and safety profile influence physician prescribing and patient adherence, thereby affecting market success.

5. What are the prospects for PLENAXIS in emerging markets?
Growing healthcare infrastructure and increasing disease prevalence offer opportunities, though pricing and reimbursement models will determine market accessibility.

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References
[1] Grand View Research. (2022). Inflammatory Bowel Disease Market Size and Forecast.
[2] Industry reports and clinical trial data for PLENAXIS.