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Alosetron hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for alosetron hydrochloride?

Alosetron hydrochloride is the generic ingredient in two branded drugs marketed by Sebela Ireland Ltd, Amneal Pharms, and West-ward Pharms Int, and is included in three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. 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 Generic Name: alosetron hydrochloride

Tradenames:2
Patents:1
Applicants:3
NDAs:3
Drug Master File Entries: see list3
Suppliers / Packagers: see list6
Bulk Api Vendors: see list50
Clinical Trials: see list986
Patent Applications: see list226
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:alosetron hydrochloride at DailyMed

Pharmacology for Ingredient: alosetron hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sebela Ireland Ltd
LOTRONEX
alosetron hydrochloride
TABLET;ORAL021107-001Feb 9, 2000RXYesYes► Subscribe► Subscribe
West-ward Pharms Int
ALOSETRON HYDROCHLORIDE
alosetron hydrochloride
TABLET;ORAL200652-001May 4, 2015RXNoNo► Subscribe► Subscribe
Sebela Ireland Ltd
LOTRONEX
alosetron hydrochloride
TABLET;ORAL021107-002Dec 23, 2003RXYesNo► Subscribe► Subscribe
Amneal Pharms
ALOSETRON HYDROCHLORIDE
alosetron hydrochloride
TABLET;ORAL206647-001Dec 22, 2016RXNoNo► Subscribe► Subscribe
West-ward Pharms Int
ALOSETRON HYDROCHLORIDE
alosetron hydrochloride
TABLET;ORAL200652-002May 4, 2015RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: alosetron hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd
LOTRONEX
alosetron hydrochloride
TABLET;ORAL021107-001Feb 9, 20005,360,800► Subscribe
Sebela Ireland Ltd
LOTRONEX
alosetron hydrochloride
TABLET;ORAL021107-002Dec 23, 20035,360,800► Subscribe
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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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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