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Details for Generic Name: alosetron hydrochloride

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Alosetron hydrochloride is the generic ingredient in two branded drugs marketed by Roxane and Prometheus Labs, and is included in two NDAs. 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-four patent family members in thirty-three 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:2
Patents:1
Applicants:2
NDAs:2
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

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roxane
ALOSETRON HYDROCHLORIDE
alosetron hydrochloride
TABLET;ORAL200652-002May 4, 2015RXNo<disabled><disabled>
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>
Roxane
ALOSETRON HYDROCHLORIDE
alosetron hydrochloride
TABLET;ORAL200652-001May 4, 2015RXNo<disabled><disabled>
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International Patent Family for Ingredient: alosetron hydrochloride

Country Document Number Publication Date
Yugoslavia20600Oct 31, 2003
New Zealand503698Oct 25, 2002
Slovakia4862000Jan 18, 2001
Norway20001776Jun 06, 2000
Estonia200000214Jun 15, 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.

Copyright 2002-2015 thinkBiotech LLC
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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