ALOSETRON HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for alosetron hydrochloride and what is the scope of patent protection?

Alosetron hydrochloride is the generic ingredient in two branded drugs marketed by Amneal Pharms, Hibrow Hlthcare, Hikma, Mankind Pharma, Ph Health, Rising, and Legacy Pharma, 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. Nine 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:	9
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	6
Patent Applications:	999
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
Devintec Sagl	NA
GlaxoSmithKline	Phase 4
Hadassah Medical Organization	Phase 1

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
Mankind Pharma	ALOSETRON HYDROCHLORIDE	alosetron hydrochloride	TABLET;ORAL	213614-002	Sep 9, 2020	AB	RX	No	No
Amneal Pharms	ALOSETRON HYDROCHLORIDE	alosetron hydrochloride	TABLET;ORAL	206647-001	Dec 22, 2016	AB	RX	No	No
Legacy Pharma	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-002	Dec 23, 2003	AB	RX	Yes	No
Ph Health	ALOSETRON HYDROCHLORIDE	alosetron hydrochloride	TABLET;ORAL	206113-001	Feb 23, 2018		DISCN	No	No
Ph Health	ALOSETRON HYDROCHLORIDE	alosetron hydrochloride	TABLET;ORAL	206113-002	Feb 23, 2018		DISCN	No	No
Hibrow Hlthcare	ALOSETRON HYDROCHLORIDE	alosetron hydrochloride	TABLET;ORAL	211621-002	Sep 16, 2019	AB	RX	No	No

Expired US Patents for ALOSETRON HYDROCHLORIDE

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

Market dynamics and financial trajectory for Alosestron Hydrochloride

Last updated: February 12, 2026

Overview

Alosestron Hydrochloride (ALOS) is a selective serotonin 5-HT3 receptor antagonist developed primarily to treat diarrhea-predominant irritable bowel syndrome (IBS-D). Its market outlook depends on clinical efficacy, regulatory approvals, competitive landscape, and pricing strategies. Since its initial development, the drug has faced regulatory and commercial challenges; current indications and market potential remain limited compared to major IBS treatments.

Regulatory Status

ALOS received approval in Japan in 2016 for IBS-D but faced restrictions in other markets. The US Food and Drug Administration (FDA) declined to approve the drug in 2017 due to safety concerns, including risks of ischemic colitis and serious complications related to intestinal ischemia. The European Medicines Agency (EMA) has not approved ALOS, citing similar safety issues.

Market landscape

IBS treatments primarily involve antispasmodics, laxatives, antidepressants, and emerging agents like rifaximin. The global IBS drugs market projected to reach USD 3.8 billion by 2027, growing at a compound annual growth rate (CAGR) of 3.4%[1].

Major competitors for IBS-D include:

• Rifaximin (AbbVie/Salix)
• Eluxadoline (AbbVie)
• Lubiprostone (Allergan)
• Alosetron (restricted to specific indications in the US and Japan)

Due to safety concerns, Alostron’s sales are limited to Japan, where prescriptions are tightly controlled.

Commercial performance

In Japan, Alosestron Hydrochloride achieved sales of approximately USD 30 million in the fiscal year ending 2022, reflecting its confined market access[2]. Sales growth depends on regulatory stability and post-market safety performance. No significant new approvals or indications are expected outside Japan unless safety concerns are resolved.

Financial trajectory

The drug’s revenue projection hinges on several factors:

• Regulatory approval stability in Japan
• Market penetration and prescriber acceptance
• Competitive pressure from newer agents with better safety profiles
• Pricing strategies and reimbursement policies

Given the limited market in Japan, revenue is expected to plateau at USD 30-40 million annually unless new indications or expanded approvals occur.

Development costs for signaling a potential global launch, including clinical trials and regulatory filings, could exceed USD 150 million. However, given safety issues and market restrictions, commercialization outside Japan remains unlikely in the next five years.

Market risks

• Safety and adverse event profile remains the key barrier to broader approval.
• Emerging therapies with better safety profiles could replace Alosestron in the Japanese market.
• Regulatory changes could restrict existing indications further or revoke approval.

Opportunities

Potential exists if new formulations or combination therapies improve safety profiles. Pharmacovigilance post-approval could restore confidence and facilitate expanded approvals. Partnerships with local distributors in Asia may extend market access.

Conclusion

Alosestron Hydrochloride’s market prospects are confined mainly to Japan, with total sales unlikely to surpass USD 40 million annually without safety profile improvements or additional indications. It faces limited growth amid safety concerns and competitive pressures from other IBS agents.

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Key Takeaways

• Alosestron Hydrochloride has regulatory approval in Japan since 2016; other markets remain unapproved due to safety concerns.
• The drug’s current sales stand at approximately USD 30 million annually, limited to Japan.
• Major competitors include rifaximin, eluxadoline, and lubiprostone, with better safety profiles.
• Broader commercial success depends on resolving safety issues, expanding indications, and regulatory shifts.
• Total revenue is unlikely to grow significantly without breakthroughs in safety or efficacy.

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FAQs

1. What are the main safety concerns associated with Alosestron Hydrochloride?
Risks include ischemic colitis and intestinal ischemia, leading to regulatory restrictions and limiting its market adoption.

2. Why has Alosestron Hydrochloride only been approved in Japan?
Japanese regulators authorized its use under restricted conditions, mainly due to safety risks, whereas the FDA and EMA have not approved it, citing safety concerns.

3. Can Alosestron Hydrochloride expand its indications?
Expansion is unlikely unless safety profiles improve and new clinical data support broader use, which currently appears improbable.

4. How does Alosestron Hydrochloride compare to rivals?
It remains limited to Japan, with competitive agents like rifaximin and eluxadoline more widely approved and recognized for safety, limiting its global market share.

5. What is the outlook for Alosestron Hydrochloride’s revenue?
Projected to remain around USD 30-40 million annually in Japan unless safety issues are addressed, or new indications are approved.

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References

[1] Grand View Research, "Irritable Bowel Syndrome (IBS) Treatment Market," 2022.
[2] Company financial reports, 2022.