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 Endo Operations, Hikma, 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:	87
Clinical Trials:	31
Patent Applications:	1,195
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
Oregon Health and Science University	Phase 4
CMC Ambroise Paré	Phase 3
The Cleveland Clinic	Phase 4

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
Endo Operations	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

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
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 ALVIMOPAN

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

ALVIMOPAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Alvimopan

Introduction

Alvimopan, marketed under the brand name Entereg, is a peripheral opioid receptor antagonist used primarily to accelerate the recovery of bowel function after surgery and to manage opioid-induced constipation. Here, we delve into the market dynamics and financial trajectory of this crucial drug.

Market Size and Growth

The global Alvimopan market is experiencing significant growth. As of 2023, the market size was valued at USD 650 million, and it is projected to reach USD 1.2 billion by 2032, exhibiting a compound annual growth rate (CAGR)[1].

Clinical Benefits and Cost Savings

Alvimopan has been shown to provide substantial clinical benefits, particularly in the context of enhanced recovery protocols for colorectal surgery. It reduces the incidence of postoperative ileus, shortens hospital length of stay, and decreases the likelihood of postoperative urinary tract infections and indwelling Foley catheter re-insertion. These benefits translate into significant cost savings, with studies indicating a reduction in patient care costs, pharmacy costs, and total variable direct hospital costs. For instance, one study found that alvimopan treatment was associated with a median cost savings of $1492 per patient, largely driven by reduced patient care costs and shorter hospital stays[2][5].

Cost-Effectiveness

Despite its high cost, alvimopan is cost-effective in the long run. The reduction in postoperative ileus and shorter hospital stays offset the cost of the medication. In patients undergoing radical cystectomy for bladder cancer, alvimopan use was associated with a reduction in hospital costs by $2709 and a decreased median length of stay from 8 to 7 days[5].

Market Competitors and Forecast

The Alvimopan market is expected to continue growing at a CAGR of 5.23%, reaching USD 6.51 billion in 2024 from USD 6.20 billion in 2023. This growth is driven by increasing demand for effective postoperative care and the expanding use of enhanced recovery protocols in various surgical procedures[4].

Patent Landscape and Generic Entry

Alvimopan is protected by several patents, with fourteen US patents and numerous international patents. However, the patent landscape is evolving, with generic versions of similar drugs like methylnaltrexone bromide (marketed as Relistor) being approved. This could potentially impact the market dynamics of alvimopan, although the specific patents protecting alvimopan are still in effect[3].

Pharmaceutical and Hospital Costs

The use of alvimopan is associated with lower patient care costs and total hospital costs. While pharmacy costs may be higher due to the medication itself, these are outweighed by the savings from reduced room and board costs resulting from shorter hospital stays. For example, in colorectal surgery, alvimopan treatment reduced patient care costs by $1261 and pharmacy-related costs by $187 per patient[2].

Industry Expert Insights

Industry experts highlight the importance of accurate and precise market research in understanding the financial trajectory of drugs like alvimopan. Customized reports that focus on specific regions or segments are crucial for companies to make informed decisions. For instance, a strategy head from a major tech company praised the accuracy and precision of market reports tailored to their requirements[1].

Clinical Trials and Research

Ongoing clinical trials and research continue to validate the benefits of alvimopan. Studies have consistently shown that alvimopan accelerates the recovery of bowel function, reduces postoperative complications, and lowers hospital costs. These findings support the routine use of alvimopan in enhanced recovery protocols for various surgical procedures[2][5].

Regional Market Dynamics

The market dynamics of alvimopan vary by region, with different countries having different patent expiration dates and regulatory environments. For example, in countries like Argentina and Australia, the patent landscape for peripheral opioid receptor antagonists is complex, with multiple patents set to expire at different times[3].

Conclusion

Alvimopan is a valuable drug in the postoperative care landscape, offering significant clinical benefits and cost savings. Its market is expected to grow substantially, driven by increasing adoption in enhanced recovery protocols and the expanding need for effective postoperative care.

Key Takeaways

• Market Growth: The global Alvimopan market is projected to reach USD 1.2 billion by 2032.
• Clinical Benefits: Alvimopan reduces postoperative ileus, shortens hospital stays, and decreases hospital costs.
• Cost-Effectiveness: Despite its high cost, alvimopan is cost-effective due to reduced patient care and pharmacy costs.
• Patent Landscape: Alvimopan is protected by several patents, but generic entries may impact market dynamics.
• Industry Insights: Accurate market research is crucial for companies to make informed decisions.

FAQs

Q: What is the primary use of alvimopan in medical settings? A: Alvimopan is primarily used to accelerate the recovery of bowel function after surgery and to manage opioid-induced constipation.

Q: How does alvimopan impact hospital costs? A: Alvimopan reduces hospital costs by decreasing the incidence of postoperative ileus, shortening hospital stays, and lowering patient care and pharmacy costs.

Q: What is the projected market size of alvimopan by 2032? A: The global Alvimopan market is projected to reach USD 1.2 billion by 2032.

Q: Are there generic versions of alvimopan available? A: As of now, there are no generic versions of alvimopan, but generic versions of similar drugs like methylnaltrexone bromide have been approved.

Q: How does alvimopan affect the length of hospital stay? A: Alvimopan is associated with a shorter hospital length of stay, typically reducing it by 1.6 days compared to control groups.

Sources

1. Dataintelo, Entereg Alvimopan Market Research Report 2032.
2. CINJ, Alvimopan Provides Additional Improvement in Outcomes and Cost Savings in Enhanced Recovery Colorectal Surgery.
3. DrugPatentWatch, When will the patents on RELISTOR expire, and when will generic versions be available?
4. ResearchAndMarkets, Alvimopan Market Size, Competitors & Forecast to 2030.
5. ScienceDirect, Alvimopan Is Associated With a Reduction in Length of Stay and Hospital Costs for Patients Undergoing Radical Cystectomy.