Alosetron hydrochloride - Generic Drug Details

What are the generic drug sources for alosetron hydrochloride and what is the scope of freedom to operate?

Alosetron hydrochloride is the generic ingredient in two branded drugs marketed by Amneal Pharms, Endo Operations, Hibrow Hlthcare, Hikma, Mankind Pharma, Rising, and Sebela Ireland Ltd, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for alosetron hydrochloride. Six suppliers are listed for this compound.

Summary for alosetron hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	5
Patent Applications:	293
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for alosetron hydrochloride
What excipients (inactive ingredients) are in alosetron hydrochloride?	alosetron hydrochloride excipients list
DailyMed Link:	alosetron hydrochloride at DailyMed

Recent Clinical Trials for alosetron hydrochloride

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

Sponsor	Phase
GlaxoSmithKline	Phase 4
Hadassah Medical Organization	Phase 1
GlaxoSmithKline	Phase 2

See all alosetron hydrochloride clinical trials

Pharmacology for alosetron hydrochloride

Drug Class	Serotonin-3 Receptor Antagonist
Mechanism of Action	Serotonin 3 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for alosetron hydrochloride

A03AE	Serotonin receptor antagonists
A03A	DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
A03	DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for ALOSETRON HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LOTRONEX	Tablets	alosetron hydrochloride	0.5 mg and 1 mg	021107	1	2010-12-02

US Patents and Regulatory Information for alosetron hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sebela Ireland Ltd	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-001	Feb 9, 2000	AB	RX	Yes	Yes
Endo Operations	ALOSETRON HYDROCHLORIDE	alosetron hydrochloride	TABLET;ORAL	206113-002	Feb 23, 2018		DISCN	No	No
Sebela Ireland Ltd	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-002	Dec 23, 2003	AB	RX	Yes	No
Hibrow Hlthcare	ALOSETRON HYDROCHLORIDE	alosetron hydrochloride	TABLET;ORAL	211621-001	Sep 16, 2019		DISCN	No	No
Amneal Pharms	ALOSETRON HYDROCHLORIDE	alosetron hydrochloride	TABLET;ORAL	206647-001	Dec 22, 2016	AB	RX	No	No
Hikma	ALOSETRON HYDROCHLORIDE	alosetron hydrochloride	TABLET;ORAL	200652-001	May 4, 2015		DISCN	No	No

Expired US Patents for alosetron hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-002	Dec 23, 2003	5,360,800
Sebela Ireland Ltd	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-001	Feb 9, 2000	6,284,770
Sebela Ireland Ltd	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-001	Feb 9, 2000	5,360,800
Sebela Ireland Ltd	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-002	Dec 23, 2003	6,284,770

Alosetron hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Alosetron Hydrochloride

Market Overview

Alosetron hydrochloride, marketed under the brand name Lotronex, is a drug primarily used for the treatment of irritable bowel syndrome (IBS) in women whose predominant bowel symptom is diarrhea. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global alosetron market is anticipated to grow at a compound annual growth rate (CAGR) of 3.50% from 2021 to 2028. This growth is driven by several key factors, including the rising prevalence of irritable bowel syndrome, an increasing geriatric population, particularly among women, and higher health expenditure[1][3].

Segmentation

The alosetron market is segmented based on several criteria:

• Dosage Type: The market is segmented into 0.5mg and 1mg tablets. The 0.5mg dosage is particularly significant due to its lower risk profile and effectiveness in managing IBS symptoms[1][3].
• Applications: The primary applications include chronic irritable bowel syndrome, visceral pain, and gastrointestinal diseases. IBS-D (diarrhea-predominant irritable bowel syndrome) is the most relevant application[1][5].
• Mode of Purchase: The market is divided into prescription and over-the-counter (OTC) segments. Given the drug's potential side effects, it is predominantly available by prescription[1].
• Distribution Channel: The drug is distributed through hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies and retail pharmacies are the main distribution channels due to the need for prescription and monitoring[1].

Geographical Analysis

Geographically, the alosetron market is analyzed across various regions:

• North America: This region is expected to hold the largest market share due to the high prevalence of IBS, favorable health policies, and increased availability of alosetron drugs. The prevalence of IBS in North America is estimated to be around 10-15%[1].
• Asia-Pacific: This region is anticipated to be the fastest-growing market, driven by the establishment of new clinics and hospitals, increased awareness about IBS symptoms, and a reliable supply of alosetron drugs[1].

Drivers and Opportunities

Several factors are driving the growth of the alosetron market:

• Increasing Prevalence of IBS: The rising number of patients suffering from IBS, particularly women, is a significant driver.
• Health Expenditure: Higher health expenditure and improved healthcare infrastructure contribute to market growth.
• Emerging Markets: Untapped opportunities in emerging markets offer potential for expansion.
• Government and R&D Activities: Increased government and research activities focused on producing alosetron drugs and enhancing healthcare architecture are also driving growth[1][3].

Restraints and Challenges

Despite the growth drivers, there are several restraints and challenges:

• Strict Regulatory Protocols: The drug's history of serious adverse events, such as ischemic colitis and complications of constipation, has led to strict regulatory protocols, which can hinder market growth[1][4].
• Side Effects: The potential for severe side effects, including ischemic colitis and constipation, remains a significant concern.
• Lack of Awareness: Limited awareness about IBS symptoms and prevention can reduce demand.
• Supply Chain Issues: Problems in the supply chain and logistics can affect the distribution of the drug[1][4].

Competitive Landscape

The competitive landscape of the alosetron market includes detailed analyses of key players:

• Company Overview: Information on company financials, revenue, market potential, and investment in R&D.
• Product Pipeline: Analysis of new market initiatives, clinical trials, product approvals, and patents.
• Global Presence: Details on production sites, facilities, company strengths, and weaknesses.
• Market Strategies: Insights into strategic decisions, product launches, and technological innovations[1][3].

Financial Trajectory

The financial trajectory of alosetron hydrochloride is influenced by several factors:

• Revenue Growth: The market is expected to grow steadily, driven by increasing demand and expanding distribution channels.
• Cost Considerations: The cost of production, distribution, and regulatory compliance can impact profitability.
• Generic Competition: The approval of generic versions of alosetron hydrochloride in 2015 has introduced competition, which can affect pricing and market share[1][4].

Risk Management and Regulatory Environment

The regulatory environment for alosetron hydrochloride is stringent due to its safety profile:

• REMS Programs: Initially, the FDA implemented a Risk Evaluation and Mitigation Strategy (REMS) program for Lotronex, which included prescriber training and enrollment. However, these requirements were later made voluntary and the prescription sticker requirement was removed[4].
• Safety Monitoring: Despite these changes, the FDA continues to monitor adverse events, and patients and prescribers must be aware of the risks associated with ischemic colitis and constipation[4].

Consumer Behavior and Market Trends

Consumer behavior and market trends play a crucial role in shaping the alosetron market:

• Patient Awareness: Increased awareness about IBS symptoms and the availability of safe medications like alosetron can drive demand.
• Alternative Treatments: The use of alternative medications, such as loperamide and ramosetron, can influence market dynamics[5].

Key Takeaways

• The alosetron market is growing at a CAGR of 3.50% from 2021 to 2028.
• North America holds the largest market share, while the Asia-Pacific region is expected to be the fastest-growing.
• The market is driven by the increasing prevalence of IBS, higher health expenditure, and emerging market opportunities.
• Strict regulatory protocols, side effects, and supply chain issues are significant restraints.
• The competitive landscape is characterized by detailed analyses of key players and their market strategies.

FAQs

What is the primary use of alosetron hydrochloride?

Alosetron hydrochloride is primarily used for the treatment of irritable bowel syndrome (IBS) in women whose predominant bowel symptom is diarrhea.

What are the key drivers of the alosetron market?

The key drivers include the increasing prevalence of IBS, higher health expenditure, and emerging market opportunities.

What are the major restraints of the alosetron market?

Major restraints include strict regulatory protocols, potential side effects such as ischemic colitis and constipation, lack of awareness about IBS symptoms, and supply chain issues.

Which region is expected to dominate the alosetron market?

North America is expected to hold the largest market share, while the Asia-Pacific region is anticipated to be the fastest-growing.

What changes have been made to the REMS program for alosetron hydrochloride?

The REMS program for alosetron hydrochloride has been modified to make prescriber training voluntary and to remove the prescription sticker requirement.

Cited Sources

1. Data Bridge Market Research: Alosetron Market Share, Size, Scope, Industry Trends & Forecast 2028.
2. Colorado Department of Health Care Policy and Financing: DUR Board Minutes_February 2024.
3. Cognitive Market Research: Alosetron Market Report 2024 (Global Edition).
4. FDA: Lotronex (alosetron hydrochloride) Information.
5. Mayo Clinic: Current and future treatments for irritable bowel syndrome associated with diarrhea.