Last updated: February 19, 2026
Alosetron hydrochloride is a selective 5-HT3 receptor antagonist approved primarily for the treatment of severe diarrhea-predominant irritable bowel syndrome (IBS-D) in women. It is a patented compound with limited manufacturer options, mainly due to regulatory restrictions and the drug’s safety profile.
Major Suppliers of Alosetron Hydrochloride
1. GlaxoSmithKline (GSK)
- Status: Original patent holder and primary supplier.
- Manufacturing: GSK developed and marketed the drug in the United States under the trade name Lotronex.
- Availability: Since the drug’s withdrawal from the U.S. market in 2000 due to safety concerns, GSK subsequently resumed limited distribution under strict guidelines.
- Regulation: GSK is the only company authorized to produce and distribute alosetron hydrochloride in the U.S., under the Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) restrictions.
2. Generic Manufacturers
- Status: Limited, as no approved generic versions are currently available.
- Legal Landscape: Patent expiration was expected around 2013–2015 but was extended or delayed in some markets through patent disputes, regulatory hurdles, or safety concerns.
- Potential Suppliers: Some Chinese and Indian pharmaceutical firms have been reported to produce alosetron hydrochloride raw material for research purposes or illegal distribution, but these are not authorized suppliers.
3. Contract Manufacturing Organizations (CMOs)
- Role: Some pharmaceutical companies utilize third-party CMOs to produce active pharmaceutical ingredients (APIs) under license or contractual agreement with GSK.
- Examples: Specific CMO data remains undisclosed, but contract suppliers are generally located in Asia (India, China) with capabilities aligned with pharmaceutical standards (GMP).
Market Dynamics and Regulatory Context
- Patent Status: Originally patent-protected until circa 2013; patent extensions or patent litigations have limited generic entry.
- Regulatory Restrictions: The drug's safety profile led to restricted distribution. Only authorized distributors, primarily GSK, supply the API or the finished drug.
- Supply Chain Challenges: Due to safety concerns, supply is tightly controlled, and potential generic suppliers face significant regulatory barriers.
Raw Material Sourcing
- Alosetron hydrochloride raw material (API) suppliers generally operate in China and India.
- Quality standards require adherence to GMP, but quality assurance varies among suppliers.
- Due to the drug's restricted status, most raw material providers are unlicensed or sell only for research use.
Key Factors Influencing Supplier Choice
| Factor |
Effect |
| Regulatory approval |
Only GSK approved for commercial distribution |
| Patent protections |
Delay or prevent generic competition |
| Manufacturing capacity |
Limited to GSK or licensed contract manufacturers |
| Quality and compliance |
Must meet GMP standards; variable among Chinese/Indian suppliers |
| Safety profile restrictions |
Only select authorized distributors handle API and medication distribution |
Summary
| Supplier Type |
Key Aspects |
| GSK |
Sole authorized manufacturer and distributor in primary markets |
| Generic pharmaceutical firms |
No active approved generics; potential unapproved sources exist |
| Contract manufacturing orgs |
Contracted to produce API for licensed use; located mainly in Asia |
References
- Food and Drug Administration. (2019). Prescription drug user fee act (PDUFA) goals. https://www.fda.gov
- GSK. (2020). Alosetron hydrochloride (Lotronex) Information. https://gsk.com
- U.S. Patent and Trademark Office. (2013). Patent status of alosetron hydrochloride. https://uspto.gov
- Chinese and Indian pharmaceutical directories. (2021). API suppliers for gastrointestinal drugs.
Key Takeaways
- GSK is the primary and currently the only authorized supplier of alosetron hydrochloride.
- No approved generic formulations exist due to patent and regulatory restrictions.
- Raw materials originate mainly from Asian manufacturers with variable compliance levels.
- Distribution is tightly controlled because of safety concerns, limiting supply chain diversity.
FAQs
1. Is alosetron hydrochloride available from multiple suppliers?
No. GSK holds the manufacturing and distribution rights; no approved generics are available.
2. Can other companies produce alosetron hydrochloride for research?
Yes, some unlicensed suppliers in China and India can produce the raw ingredient for research, but these are not authorized for commercial use.
3. What is the patent status of alosetron hydrochloride?
Patents expired around 2013–2015, but patent disputes and safety restrictions delayed generic entry.
4. Are there any regulatory restrictions on alosetron hydrochloride supply?
Yes. Distribution is restricted by the FDA due to safety concerns, requiring GSK approval for distribution.
5. Who are the main contract manufacturers for alosetron hydrochloride?
Specific contract manufacturers are not publicly disclosed but are believed to be located in India and China, licensed to produce APIs under GMP standards.
