Alvimopan - Generic Drug Details

What are the generic sources for alvimopan and what is the scope of patent protection?

Alvimopan is the generic ingredient in two branded drugs marketed by Hikma, Ph Health, Watson Labs Teva, and Cubist Pharms, and is included in four NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alvimopan has one patent family member in one country.

There are four drug master file entries for alvimopan. Four suppliers are listed for this compound.

Summary for alvimopan

International Patents:	1
US Patents:	1
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	32
Patent Applications:	1,230
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for alvimopan
What excipients (inactive ingredients) are in alvimopan?	alvimopan excipients list
DailyMed Link:	alvimopan at DailyMed

Recent Clinical Trials for alvimopan

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

Sponsor	Phase
Memorial Sloan Kettering Cancer Center	PHASE3
Oregon Health and Science University	Phase 4
CMC Ambroise Paré	Phase 3

See all alvimopan clinical trials

Pharmacology for alvimopan

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for alvimopan

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for ALVIMOPAN

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

US Patents and Regulatory Information for alvimopan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	ALVIMOPAN	alvimopan	CAPSULE;ORAL	217753-001	Aug 31, 2023	AB	RX	No	No
Watson Labs Teva	ALVIMOPAN	alvimopan	CAPSULE;ORAL	208295-001	Dec 19, 2019	AB	RX	No	Yes
Ph Health	ALVIMOPAN	alvimopan	CAPSULE;ORAL	216843-001	Jan 24, 2023	AB	RX	No	No
Cubist Pharms	ENTEREG	alvimopan	CAPSULE;ORAL	021775-001	May 20, 2008		DISCN	Yes	No	8,946,262

Expired US Patents for alvimopan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cubist Pharms	ENTEREG	alvimopan	CAPSULE;ORAL	021775-001	May 20, 2008	5,250,542
Cubist Pharms	ENTEREG	alvimopan	CAPSULE;ORAL	021775-001	May 20, 2008	6,469,030
Cubist Pharms	ENTEREG	alvimopan	CAPSULE;ORAL	021775-001	May 20, 2008	5,434,171

International Patents for alvimopan

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005055953

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Alvimopan

Last updated: July 28, 2025

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Introduction

Alvimopan, marketed under brand names such as Entereg, is a peripherally acting opioid antagonist primarily indicated for accelerating gastrointestinal recovery following partial bowel resection surgeries with primary anastomosis. Since its FDA approval in 2008, alvimopan’s market presence and financial performance have been shaped by evolving regulatory landscapes, clinical developments, and emerging competitors. Analyzing current market dynamics reveals insights into its growth potential, competitive positioning, and investment considerations within the broader gastrointestinal pharmacotherapy segment.

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Regulatory and Clinical Landscape

Alvimopan’s journey commenced with a pivotal FDA approval in 2008, driven by clinical trials demonstrating reductions in postoperative ileus duration. However, the drug’s path to market was complicated by safety concerns regarding cardiovascular risks; these concerns led to a voluntary market withdrawal in 2010. Subsequent mid-2010s regulatory reviews resulted in a restricted indication primarily for hospitalized postoperative patients, with prescriptive guidelines limiting outpatient use.

The clinical efficacy of alvimopan remains well-supported for specific subsets, notably in reducing postoperative ileus duration and hospital length of stay. Nevertheless, safety considerations and the necessity for strict patient monitoring restrain its broader adoption. The drug's regulatory status continues to influence its market access and prescribing patterns, with ongoing monitoring potentially impacting future sales trajectories.

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Market Size and Growth Drivers

The global gastrointestinal therapeutic market is projected to grow at compounded annual growth rates (CAGRs) of approximately 5% over the next five years, driven by increasing surgical procedures, aging populations, and enhanced awareness of postoperative recovery management. Alvimopan, positioned within this niche, benefits from the increasing volume of colorectal and gastrointestinal surgeries.

Key market drivers include:

• Rising Surgical Volumes: An aging global population coupled with advancements in minimally invasive surgeries increases the number of gastrointestinal resections, directly expanding the potential patient pool for alvimopan.
• Clinical Adoption in Hospitals: Limited outpatient eligibility due to safety profiles confines alvimopan’s utilization largely within inpatient settings, bolstering hospital-based revenue streams.
• Enhanced Postoperative Recovery Protocols: The shift toward Enhanced Recovery After Surgery (ERAS) protocols emphasizes the importance of gastrointestinal motility agents, positioning alvimopan favorably when safety criteria are met.

Despite these drivers, alvimopan's market penetration remains modest compared to broader opioid or gastrointestinal pharmacotherapies, constrained by safety concerns, reimbursement policies, and drug labeling restrictions.

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Competitive Dynamics

Alvimopan faces competition from alternative treatments aimed at reducing postoperative ileus, including:

• Non-pharmacologic Strategies: Enhanced recovery protocols emphasizing early mobilization and nutritional support.
• Other Pharmacologics: The emergence of new agents such as methylnaltrexone and naloxegol, which target opioid-induced gastrointestinal dysfunction but are primarily used in chronic constipation and opioid-induced bowel dysfunction contexts.

Moreover, numerous pharmaceutical companies are investing in developing novel peripherally restricted opioid antagonists with improved safety profiles and broader indications. The competitive landscape emphasizes the importance of demonstrating clear clinical benefits, safety, and cost-effectiveness to capture market share.

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Financial Trajectory and Revenue Outlook

Revenue Performance:
Alvimopan’s global sales remain limited relative to blockbuster drugs, with revenues estimated in the low hundreds of millions annually. In the United States, where the drug is primarily marketed, sales are influenced by hospital adoption rates, reimbursement policies, and prescriber familiarity. Post-2010, revenues fluctuated due to safety concerns and evolving regulatory scrutiny, with some years witnessing declines.

Growth Potential:
The financial outlook hinges on several factors:

• Regulatory Reopening: Potential expansion of approved indications or relaxed prescribing constraints could significantly boost market size.
• Hospital Adoption: Increasing integration of ERAS protocols optimizes the adoption of gastrointestinal motility agents, likely elevating demand.
• Market Penetration Strategies: Companies may increase marketing efforts and clinician education to expand hospital use, especially in high-volume surgical centers.

Market Risks:

• Safety restrictions may persist or become more stringent, capping growth.
• Competitive agents with improved safety and efficacy profiles can erode market share.
• Reimbursement challenges and hospital budget constraints may limit prescribing expansion.

Forecasts & Projections:
Industry analysts project a gradual increase in alvimopan’s revenues, contingent on regulatory outcomes and market acceptance. While not expected to reach blockbuster levels, steady growth in surgical volumes and protocol integration positions alvimopan as a stable niche player.

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Emerging Trends and Future Outlook

The future trajectory of alvimopan hinges on:

• Regulatory Developments: Approval for outpatient use or expanded indications could open new revenue horizons.
• Clinical Trials: Ongoing studies assessing safety and efficacy influence prescriber confidence and payer coverage.
• Innovative Competitors: Development of next-generation peripherally acting antagonists with enhanced safety and convenience profiles may challenge existing market leaders.
• Health System Dynamics: Increasing hospital investments in postoperative recovery management, coupled with value-based care models, could favor agents like alvimopan that reduce hospital stays and complications.

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Conclusion

Alvimopan’s market dynamics are characterized by a constrained but steady niche presence, supported by targeted clinical applications in postoperative gastrointestinal recovery. Regulatory and safety considerations continue to shape its financial trajectory, with growth projected to be moderate unless new approvals or indications are obtained. Its future success depends on clinical validation, regulatory progress, and strategic positioning within evolving surgical recovery protocols.

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Key Takeaways

• Regulatory and safety hurdles significantly influence alvimopan’s market access and revenue potential.
• Growing surgical volumes and ERAS protocols serve as primary growth drivers within its niche market.
• Competitive landscape is evolving with alternative therapies and novel agents offering safety advantages.
• Financial outlook suggests moderate, steady growth, contingent upon regulatory restrictions and market adoption.
• Strategic focus on clinical evidence and hospital-based integration will be vital for expanding market share.

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FAQs

1. What is the primary indication for alvimopan?
   Alvimopan is primarily indicated to accelerate gastrointestinal recovery following partial bowel resection surgeries with primary anastomosis, aiming to reduce postoperative ileus duration.

2. How have safety concerns impacted alvimopan's market presence?
   Post-approval safety issues regarding cardiovascular risks led to market withdrawal and restrictions, limiting its use largely to inpatient settings and reducing its overall market penetration.

3. What are the main competitors to alvimopan?
   Alternatives include other peripherally acting opioid antagonists like methylnaltrexone and naloxegol and non-pharmacologic measures such as ERAS protocols.

4. What factors could drive future growth for alvimopan?
   Expansion of FDA-approved indications, regulatory easing, increased hospital adoption driven by ERAS protocols, and ongoing clinical support could boost sales.

5. What are the risks to alvimopan’s financial trajectory?
   Persistent safety restrictions, competition from newer agents, reimbursement challenges, and limited outpatient applicability pose significant risks.

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References

[1] U.S. Food and Drug Administration. (2008). FDA approves Entereg to accelerate recovery of bowel function after surgery.
[2] MarketWatch. (2022). Gastrointestinal therapeutics market size and forecast.
[3] EvaluatePharma. (2022). Pharmaceutical pipeline and competitive landscape analysis.
[4] Company SEC filings. (2023). Financial reports and revenue disclosures related to alvimopan.
[5] ClinicalTrials.gov. (2023). Ongoing studies on alvimopan safety and efficacy.