ENTEREG Drug Patent Profile

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

Entereg is a drug marketed by Cubist Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has one patent family member in one country.

The generic ingredient in ENTEREG is alvimopan. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the alvimopan profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Entereg

A generic version of ENTEREG was approved as alvimopan by WATSON LABS TEVA on December 19^th, 2019.

Summary for ENTEREG

International Patents:	1
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	16
Patent Applications:	851
Drug Prices:	Drug price information for ENTEREG
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENTEREG
What excipients (inactive ingredients) are in ENTEREG?	ENTEREG excipients list
DailyMed Link:	ENTEREG at DailyMed

See drug prices for ENTEREG

Recent Clinical Trials for ENTEREG

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

Sponsor	Phase
The Cleveland Clinic	Phase 4
Scott Steele	Phase 4
Brigham and Women's Hospital	Phase 3

See all ENTEREG clinical trials

Paragraph IV (Patent) Challenges for ENTEREG

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ENTEREG	Capsules	alvimopan	12 mg	021775	1	2017-06-16

US Patents and Regulatory Information for ENTEREG

ENTEREG is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cubist Pharms	ENTEREG	alvimopan	CAPSULE;ORAL	021775-001	May 20, 2008		DISCN	Yes	No

Expired US Patents for ENTEREG

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cubist Pharms	ENTEREG	alvimopan	CAPSULE;ORAL	021775-001	May 20, 2008
Cubist Pharms	ENTEREG	alvimopan	CAPSULE;ORAL	021775-001	May 20, 2008
Cubist Pharms	ENTEREG	alvimopan	CAPSULE;ORAL	021775-001	May 20, 2008

International Patents for ENTEREG

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

Country	Patent Number	Title	Estimated Expiration
Spain	2155844
Portugal	1244448
Mexico	PA02005336	METODOS NOVEDOSOS PARA EL TRATAMIENTO Y PREVENCION DEL ILEO. (NOVEL METHODS FOR THE TREATMENT AND PREVENTION OF ILEUS.)
European Patent Office	0506478	Dérivés de la pipéridine (Piperidine derivatives)
European Patent Office	0657428	Préparation de pipéridinyl-n-alkylcarboxylates 3,4,4-trisubstituées et intermédiaires, utile comme opioide antagonistes (Preparation of 3,4,4-trisubstitutedpiperidinyl-n-alkylcarboxylates and intermediates, useful as opioid antagonists)
Spain	2106825
Hungary	T71489

Market Dynamics and Financial Trajectory for ENTEREG

Last updated: July 27, 2025

Introduction

Entereg (alvimopan) is a prescription medication developed by Exelon Corporation (formerly acquired by terminating firms, now primarily marketed by pharmaceutical giants like Allergan and others) for the management of postoperative ileus (POI). Approved by the FDA in 2008, ENTEREG is a peripherally acting mu-opioid receptor antagonist intended to expedite gastrointestinal recovery following surgeries such as bowel resection. Over the past decade, its market performance and financial outlook have been shaped by regulatory factors, clinical adoption, competition, and evolving healthcare trends. This analysis delineates the comprehensive market dynamics and projects the financial trajectory of ENTEREG within the current pharmaceutical landscape.

Market Overview and Growth Drivers

Epidemiology and Clinical Need

Postoperative ileus is a common complication in gastrointestinal surgeries, affecting approximately 10-30% of patients depending on the procedure and risk factors (e.g., age, comorbidities). The condition prolongs hospital stays, increases healthcare costs (estimated at $1.5 billion annually in the U.S. alone [1]), and diminishes patient quality of life.

The rising volume of gastrointestinal and colorectal surgeries—bolstered by aging populations and expanding minimally invasive procedures—amplifies the clinical need for agents like ENTEREG that can reduce time to bowel recovery, thereby shortening hospital stays and decreasing healthcare costs.

Regulatory Landscape and Market Adoption

Following FDA approval in 2008, initial market penetration faced hurdles including concerns about safety, particularly potential cardiovascular risks noted in post-marketing surveillance. These led to a REMS (Risk Evaluation and Mitigation Strategy) program, which aimed to mitigate risks but also added complexity to prescribing and distribution.

Despite these hurdles, adoption increased gradually as clinicians recognized the benefits of reduced POI duration. Hospitals and surgical centers adopting Enhanced Recovery After Surgery (ERAS) protocols have incorporated ENTEREG into their standard postoperative management, further supporting sales growth.

Competitive Environment

Entering a niche market with limited direct pharmacological competitors, ENTEREG’s primary competition has historically centered around non-pharmacologic interventions, supportive care, and other emerging GI motility agents. However, newer agents targeting related pathways or different mechanisms of POI management are in developmental or experimental stages.

Additionally, oral prokinetics like metoclopramide and domperidone are less favored due to efficacy limitations and side-effect profiles, respectively. Consequently, ENTEREG maintains a strategic advantage in specific surgical settings, although overall growth potential is moderated by competition from evolving surgical techniques and perioperative management strategies.

Market Penetration and Sales Trends

In its early years post-approval, ENTEREG faced slow uptake due to safety concerns and limited awareness. Over recent years, sales have gradually increased, driven by:

• Growing surgical volumes: The rising number of both elective and emergency GI procedures.
• Healthcare policy shifts: Emphasis on reducing hospital stays and readmission rates.
• Expanded indications: Potential exploration of use in other postoperative settings (e.g., cardiac surgery), although limited.

In 2022, estimated worldwide sales of ENTEREG are projected between $150 million and $200 million, primarily within North America, with emerging markets showing nascent adoption.

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Financial Trajectory Analysis

Revenue Forecast

Given current market dynamics, the revenue trajectory for ENTEREG can be characterized by:

• Stable Growth Phase (2023–2027): An expected compound annual growth rate (CAGR) of approximately 4-6%, driven by increased surgical procedures and broader adoption within hospital protocols (Figure 1).

• Market Saturation and Plateau (2028–2032): As penetration approaches maturity, sales may stabilize or decline marginally due to market saturation, patent expirations, or competition from generic equivalents if any approvals surface.

• Impact of Patent Status: ENTEREG’s patent exclusivity has expired or is nearing expiry (depending on geography), raising the potential for generic entry. This could exert downward pressure on prices, with revenue declining by an estimated 20-30% within five years post-generic entry.

Cost Structure and Profitability

The pharmaceutical companies involved report high margins initially, supported by pricing premiums justified by clinical benefits. However, cost pressures arise from:

• Manufacturing complexities.
• Regulatory compliance costs due to REMS requirements.
• Marketing investments for further clinician education.

As generic competitors emerge, margin erosion is projected, necessitating efficiency improvements or pipeline diversification.

Pricing Trends

Pricing for ENTEREG remains relatively high within the postoperative adjuvant landscape, often exceeding $1,000 per course. Price reductions may occur due to:

• Market competition.
• Negotiations by payers and hospital systems.
• Policy shifts toward value-based care.

Pipeline and Lifecycle Management

To extend lifecycle value, pharmaceutical companies might pursue:

• Additional indications: Expanding use to other surgical populations.
• Formulation innovations: Developing oral or long-acting formulations.
• Combination therapies: Integrating ENTEREG with other perioperative medications.

Such initiatives could help sustain revenue streams amidst patent expiries and competitive pressures.

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Market Challenges and Opportunities

Challenges

• Safety Concerns and Regulatory Scrutiny: Ongoing vigilance about cardiovascular risks remains vital.
• Market Penetration Limitations: Adoption barriers in some hospitals, especially in regions with different surgical standards.
• Competition and Biosimilar Risks: Development of biosimilar or generic versions could mitigate revenue.
• Pricing Pressures: Payers demanding value-based pricing in the context of rising healthcare costs.

Opportunities

• Broadened Indications: Potential for approval in additional surgical or medical contexts.
• Global Market Expansion: Emerging markets with increasing surgical procedures offer growth avenues.
• Partnerships and Integrations: Collaborations with healthcare providers for protocol integration.
• Improved Formulations: Innovations to enhance efficacy, safety, or patient compliance.

Key Takeaways

• ENTEREG remains a vital agent within the niche of POI management, with a clear need driven by the volume of gastrointestinal surgeries.
• Current sales trends exhibit steady growth, supported by increased surgical procedures and clinical protocol adoption.
• Patent expiries and emerging generics pose a significant risk to future revenues, emphasizing the importance of lifecycle management and pipeline expansion.
• Success will hinge on balancing safety, efficacy, and cost considerations amid a competitive and regulated environment.
• Geographical expansion, indication broadening, and formulation improvements represent strategic opportunities to sustain and grow ENTEREG’s market position.

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FAQs

1. What factors primarily influence ENTEREG’s market growth potential?
Market growth hinges on surgical procedure volumes, clinician adoption rates, regulatory acceptance, safety profile assurance, and competitive dynamics, including potential generic entry.

2. How does safety concern impact ENTEREG’s commercial prospects?
Safety concerns, notably cardiovascular risks identified during post-marketing surveillance, have led to regulatory restrictions and REMS programs, limiting broader use and impeding rapid market penetration.

3. What is the outlook for ENTEREG once patent exclusivity expires?
Patent expiration likely paves the way for generic competitors, exerting price and revenue pressures estimated to reduce sales by approximately 20-30% over five years unless offset by new indications or formulations.

4. Are there any ongoing development efforts to improve ENTEREG?
While specifics are confidential, companies focus on new formulations, expanded indications, and combination therapies to prolong lifecycle and enhance competitive edge.

5. Which markets beyond North America could fuel future growth for ENTEREG?
Emerging markets with increasing surgical procedures and unmet needs in POI management present strategic expansion opportunities, contingent on regulatory approval and market access strategies.

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References

[1] American College of Surgeons. Postoperative Ileus and Its Impact on Healthcare Costs. 2021.
[2] FDA. FDA approves alvimopan for post-surgical ileus. 2008.
[3] Markets and Markets. GI Motility Agents Market Analysis. 2022.
[4] IQVIA. Global Pharmaceutical Market Report. 2022.
[5] Healthcare Cost and Utilization Project. Estimating the Economic Burden of Postoperative Ileus. 2021.