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:	158
Clinical Trials:	16
Patent Applications:	847
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
Scott Steele	Phase 4
The Cleveland Clinic	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
Norway	921182
Australia	7917094
Denmark	0506478

ENTEREG Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Entereg (Alvimopan)

Introduction

Entereg, known by its generic name alvimopan, is a peripherally acting mu-opioid receptor antagonist that has gained significant attention for its role in managing postoperative ileus and opioid-induced constipation. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its current status, future projections, and the factors influencing its market performance.

Market Size and Growth Projections

The global market for Entereg (alvimopan) is anticipated to experience substantial growth. By 2032, the market size is projected to reach USD 1.2 billion, up from USD 650 million in 2023, exhibiting a compound annual growth rate (CAGR) of around 6-7%[4].

Market Segmentation

The market for alvimopan can be segmented based on several factors:

By Drug Class

Alvimopan falls under the category of peripherally acting mu-opioid receptor antagonists. This class of drugs is crucial for managing opioid-induced constipation and postoperative ileus without affecting the central nervous system's opioid-mediated analgesic effects[1].

By Route of Administration

Alvimopan is administered orally, which is a preferred route due to its ease of use and patient compliance. Other routes, such as rectal and intravenous, are less common for this drug[1].

By Indication

The primary indications for alvimopan include opioid-induced constipation and the prevention of postoperative ileus following bowel resection surgery. Its use in enhanced recovery after surgery (ERAS) protocols is also significant[2][5].

By Region

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Developed regions like North America and Europe are expected to drive the market due to higher healthcare spending and better reimbursement policies[1].

Financial Impact and Cost Savings

Alvimopan has been shown to have a positive financial impact on healthcare systems. Studies have demonstrated that patients receiving alvimopan have significantly lower total hospital costs compared to those not receiving the drug.

Hospital Costs

A retrospective matched cohort study found that patients treated with alvimopan had a mean total hospital cost of $12,865, which was $1,040 lower than the cost for controls. Additionally, alvimopan was associated with a shorter length of stay, averaging 5.6 days compared to 6.5 days for controls[2].

Cost Savings in Colorectal Surgery

In the context of enhanced recovery colorectal surgery protocols, alvimopan has been associated with a hospital cost savings of $1,492 per patient. This savings is largely driven by reductions in patient care costs and pharmacy-related costs due to the lower incidence of postoperative ileus and shorter hospitalization[5].

Market Drivers

Several factors drive the market for alvimopan:

Increasing Surgical Procedures

The rise in surgical procedures, particularly bowel resections and other surgeries that can lead to postoperative ileus, increases the demand for alvimopan.

Growing Awareness and Adoption

Enhanced recovery after surgery (ERAS) protocols, which often include alvimopan, are becoming more widely adopted, driving up demand for the drug.

Regulatory Approvals and Reimbursement

Favorable regulatory approvals and reimbursement policies in various regions support the market growth of alvimopan.

Market Challenges

Despite the positive outlook, there are challenges to consider:

High Drug Costs

Alvimopan is a costly medication, which can be a barrier to its adoption, especially in regions with limited healthcare budgets.

Contraindications

Alvimopan is contraindicated in patients with a history of opioid use for more than 7 consecutive days immediately before taking the drug, which limits its use in certain patient populations[5].

Competition

The market for opioid-induced constipation and postoperative ileus treatments is competitive, with other drugs and therapies available. However, alvimopan's unique mechanism of action and proven efficacy give it a strong market position.

Expert Insights and Statistics

Industry experts highlight the cost-effectiveness of alvimopan despite its high cost. For instance, a study noted that "despite the high cost of alvimopan, pharmacy-related costs were reduced, underscoring the cost-effectiveness of this expensive medication"[5].

"Alvimopan administration as an element of enhanced recovery colorectal surgery is associated with faster return of bowel function, lower incidence of postoperative ileus, shorter hospitalization, and a significant cost savings." - Mohamed Abdelgadir Adam, MD, et al.[5]

Future Outlook

The future of the alvimopan market looks promising, driven by increasing demand for effective treatments for postoperative ileus and opioid-induced constipation. The projected market size and growth rate indicate a robust financial trajectory for this drug.

Key Takeaways

• The global Entereg (alvimopan) market is expected to reach USD 1.2 billion by 2032.
• Alvimopan significantly reduces hospital costs and length of stay.
• The drug is a key component in enhanced recovery after surgery (ERAS) protocols.
• High drug costs and contraindications are significant challenges.
• Favorable regulatory approvals and reimbursement policies support market growth.

FAQs

What is the primary indication for alvimopan?

Alvimopan is primarily indicated for the prevention of postoperative ileus following bowel resection surgery and for managing opioid-induced constipation.

How does alvimopan reduce hospital costs?

Alvimopan reduces hospital costs by decreasing the incidence of postoperative ileus, shortening the length of hospital stay, and lowering patient care and pharmacy-related costs.

What is the projected market size for alvimopan by 2032?

The global market for alvimopan is projected to reach USD 1.2 billion by 2032.

What are the main challenges facing the alvimopan market?

The main challenges include the high cost of the drug and contraindications in patients with a history of opioid use.

How does alvimopan fit into enhanced recovery after surgery (ERAS) protocols?

Alvimopan is included in ERAS protocols to accelerate the return of bowel function, reduce the incidence of postoperative ileus, and shorten hospitalization, thereby enhancing patient outcomes and reducing costs.

Sources

1. Market Research Future: Opioid Induced Constipation Drug Market Growth Trends 2032 | MRFR
2. PubMed: Impact of alvimopan (entereg) on hospital costs after bowel resection
3. Margaret Kyle: Investments in Pharmaceuticals Before and After TRIPS
4. DataIntelo: Entereg Alvimopan Market Research Report 2032
5. CINJ: Alvimopan Provides Additional Improvement in Outcomes and Cost Savings in Enhanced Recovery Colorectal Surgery