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Details for Generic Name: alosetron hydrochloride

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Alosetron hydrochloride is the generic ingredient in one branded drug marketed by Prometheus Labs and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-one patent family members in thirty countries.

There are three drug master file entries for alosetron hydrochloride. One supplier is listed for this compound.

Summary for Generic Name: alosetron hydrochloride

Tradenames:1
Patents:1
Applicants:1
NDAs:1
Drug Master File Entries: see list3
Suppliers: see list1
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: alosetron hydrochloride

Clinical Trials for: alosetron hydrochloride

Safety and Efficacy Study of GR68755 (Alosetron Hydrochloride) to Treat Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS)
Status: Completed Condition: Irritable Colon

Study to Assess the Effect Of Alosetron On Mucosal Blood Flow
Status: Completed Condition: Irritable Bowel Syndrome (IBS)

Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy
Status: Completed Condition: Irritable Colon; Irritable Bowel Syndrome (IBS)

Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy
Status: Completed Condition: Irritable Colon; Irritable Bowel Syndrome (IBS)

LOTRONEX® in Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Status: Completed Condition: Irritable Bowel Syndrome

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Prometheus Labs
LOTRONEX
alosetron hydrochloride
TABLET;ORAL021107-001Feb 9, 2000RXYes6,284,770<disabled><disabled>
Prometheus Labs
LOTRONEX
alosetron hydrochloride
TABLET;ORAL021107-002Dec 23, 2003RXNo6,284,770<disabled><disabled>
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Non-Orange Book Patents for Generic Ingredient: alosetron hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,593,336 Methods for treating irritable bowel syndrome<disabled in preview>
6,429,209 Methods for treating irritable bowel syndrome<disabled in preview>
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International Patent Family for Ingredient: alosetron hydrochloride

Country Document Number Publication Date
Colombia5011096Feb 28, 2001
Algeria2618Mar 01, 2003
New Zealand503698Oct 25, 2002
Poland340337Jan 29, 2001
Uruguay25200Jan 31, 2001
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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