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
Cubist Pharms	ENTEREG	alvimopan	CAPSULE;ORAL	021775-001	May 20, 2008		DISCN	Yes	No	8,946,262
Ph Health	ALVIMOPAN	alvimopan	CAPSULE;ORAL	216843-001	Jan 24, 2023	AB	RX	No	No
Watson Labs Teva	ALVIMOPAN	alvimopan	CAPSULE;ORAL	208295-001	Dec 19, 2019	AB	RX	No	Yes

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	5,434,171
Cubist Pharms	ENTEREG	alvimopan	CAPSULE;ORAL	021775-001	May 20, 2008	6,469,030

International Patents for ALVIMOPAN

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

Alvimopan Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is Alvimopan?

Alvimopan is an orally administered peripherally acting mu-opioid receptor antagonist. Its primary indication is for the short-term enhancement of gastrointestinal recovery following specific types of bowel resection surgery. It functions by blocking the effects of opioids on the gastrointestinal tract, thereby mitigating postoperative ileus (POI), a common complication characterized by the temporary cessation of bowel motility. This action aims to accelerate the return of bowel function, reduce hospital stay duration, and improve patient recovery trajectories post-surgery.

Intellectual Property Landscape

The intellectual property surrounding alvimopan is primarily driven by patents covering its composition of matter, methods of use, and manufacturing processes. Entereg (alvimopan) was initially developed by Adolor Corporation and later acquired by GlaxoSmithKline (GSK). The original composition of matter patents have largely expired, opening avenues for generic competition.

Key patent families associated with alvimopan include:

• Composition of Matter: Patents covering the molecular structure of alvimopan. The foundational patents for alvimopan have expired.
• Methods of Use: Patents detailing the therapeutic applications of alvimopan, particularly for the prevention and treatment of POI in surgical patients. These patents have varying expiration dates, with some having expired or nearing expiration.
• Formulation and Manufacturing: Patents related to specific formulations of alvimopan and the processes used to synthesize the drug. These patents can provide extended protection for specific product versions or manufacturing efficiencies.

The expiration of key patents has historically led to increased generic interest. A generic version of alvimopan was approved by the U.S. Food and Drug Administration (FDA) in 2023. This regulatory event signals a significant shift in the market landscape, moving from a branded monopoly to a competitive generic environment.

Market Performance and Sales Data

Alvimopan, marketed under the brand name Entereg by GSK, has shown a consistent sales trajectory, influenced by its specific indication and market access.

Entereg (Alvimopan) Net Sales (USD millions):

Year	Net Sales
2020	212
2021	227
2022	227
2023	217

(Source: GlaxoSmithKline Annual Reports)

The sales figures indicate a stable, albeit mature, market for Entereg. The slight decline observed in 2023 can be attributed to factors including increased competition from generics, potential shifts in prescribing patterns, and ongoing healthcare policy impacts.

The market for alvimopan is niche, primarily serving patients undergoing specific gastrointestinal surgeries. Its adoption is influenced by hospital formularies, surgeon preference, and healthcare economics that value reduced hospital stays and improved patient outcomes.

Competitive Landscape

The competitive landscape for alvimopan has evolved significantly with the advent of generic alternatives. Prior to the approval of generic alvimopan, the market was largely dominated by branded Entereg.

Key Competitors and Dynamics:

• Branded Entereg (GSK): Maintains a significant market share due to established physician relationships, brand recognition, and continued marketing efforts.
• Generic Alvimopan: The introduction of generic versions by multiple manufacturers intensifies price competition and offers cost-saving alternatives for healthcare systems and payers. This is expected to lead to price erosion for alvimopan.
• Alternative Therapies: While alvimopan targets POI specifically, other approaches to managing postoperative recovery exist, including non-pharmacological interventions (e.g., early ambulation, gum chewing) and alternative pharmacological agents that may address broader aspects of recovery or have different side effect profiles. However, alvimopan remains a key option for its targeted mechanism of action.

The entry of generics typically leads to a substantial reduction in average selling prices. This dynamic is a critical consideration for both manufacturers of branded drugs and generic companies seeking to establish market share.

Regulatory Environment and Post-Approval Considerations

The regulatory journey of alvimopan has included significant post-approval requirements and monitoring. Alvimopan's FDA approval was initially followed by a Risk Evaluation and Mitigation Strategy (REMS) due to concerns about potential cardiovascular events in patients with prolonged use or existing cardiovascular conditions.

Key Regulatory Aspects:

• REMS Program: The REMS program for Entereg, initially stringent, was subsequently modified to allow for broader use with appropriate risk management. This evolution reflects ongoing safety data review and risk-benefit assessments by regulatory authorities. The modification allowed for its use in a wider patient population within certain parameters.
• Generic Approvals: The FDA's approval of generic alvimopan signifies that these products have met the same rigorous standards for safety, efficacy, and quality as the branded product. This process opens the market to increased accessibility and affordability.
• Ongoing Surveillance: Pharmaceutical products, especially those with a history of risk management programs, are subject to ongoing pharmacovigilance and post-market surveillance to detect any new or emerging safety concerns.

The regulatory environment directly impacts market access, prescribing guidelines, and the overall commercial viability of both branded and generic alvimopan.

Financial Projections and Investment Outlook

The financial trajectory of alvimopan is characterized by a mature branded product facing increasing competition from generics.

Financial Considerations:

• Branded Sales Decline: Projections for branded Entereg sales anticipate a continued decline as generic penetration increases. GSK will likely focus on maximizing remaining profitability through efficient manufacturing and targeted marketing.
• Generic Market Growth: The generic alvimopan market is expected to grow as more manufacturers enter and gain market share. Profitability for generic manufacturers will depend on manufacturing costs, market access, and pricing strategies.
• Pricing Pressure: The introduction of generics will exert significant downward pressure on the average selling price of alvimopan, impacting overall market revenue.
• R&D Investment: Further significant R&D investment in alvimopan itself is unlikely. Future research may focus on potential new indications or improved formulations, but the primary financial driver will be the existing approved use.

For investors, the alvimopan market represents a transition from a stable, branded revenue stream to a more fragmented and price-sensitive generic market. Opportunities exist for generic manufacturers with efficient production and strong distribution networks. Investments in the branded product will be characterized by managing a declining asset, while investments in generic alvimopan will focus on capturing market share in a competitive environment.

Key Takeaways

• Alvimopan is an orally administered mu-opioid receptor antagonist used to accelerate gastrointestinal recovery post-bowel resection surgery.
• The intellectual property landscape has shifted significantly with the expiration of key composition of matter patents, paving the way for generic competition.
• Branded Entereg (alvimopan) sales have been stable but show a declining trend, with net sales reported at $217 million in 2023.
• The introduction of generic alvimopan by multiple manufacturers marks a transition to a competitive pricing environment, impacting overall market revenue.
• Regulatory history includes a modified REMS program, and the FDA's approval of generic alvimopan underscores its adherence to safety and efficacy standards.
• Financial projections indicate a continued decline in branded sales and growth in the generic market, driven by price competition.

Frequently Asked Questions

1. What is the primary mechanism of action for alvimopan? Alvimopan functions as a peripherally acting mu-opioid receptor antagonist, blocking the inhibitory effects of opioids on gastrointestinal motility.

2. When did generic versions of alvimopan become available in the U.S.? Generic alvimopan received U.S. FDA approval in 2023.

3. What was the main concern that led to a REMS program for Entereg? The REMS program was initially implemented due to concerns regarding potential cardiovascular events associated with its use.

4. Which type of surgical procedure is alvimopan most commonly indicated for? Alvimopan is indicated for short-term use to enhance gastrointestinal recovery following specific types of bowel resection surgery.

5. How has the introduction of generic alvimopan impacted the market price of the drug? The introduction of generics is expected to lead to significant price erosion and increased pricing pressure across the alvimopan market.

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Citations

[1] GlaxoSmithKline. (2021-2023). Annual Reports. Retrieved from company investor relations filings.