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LOTRONEX Drug Profile

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Lotronex is a drug marketed by Sebela Ireland Ltd and is included in one NDA. It is available from three suppliers.

The generic ingredient in LOTRONEX is alosetron hydrochloride. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the alosetron hydrochloride profile page.

Summary for Tradename: LOTRONEX

Patents:0
Applicants:1
NDAs:1
Suppliers / Packagers: see list3

Pharmacology for Tradename: LOTRONEX

Clinical Trials for: LOTRONEX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sebela Ireland Ltd
LOTRONEX
alosetron hydrochloride
TABLET;ORAL021107-002Dec 23, 2003RXNo<disabled><disabled>
Sebela Ireland Ltd
LOTRONEX
alosetron hydrochloride
TABLET;ORAL021107-001Feb 9, 2000RXYes<disabled><disabled>
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Expired Patents for Tradename: LOTRONEX

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd
LOTRONEX
alosetron hydrochloride
TABLET;ORAL021107-002Dec 23, 20035,360,800<disabled>
Sebela Ireland Ltd
LOTRONEX
alosetron hydrochloride
TABLET;ORAL021107-001Feb 9, 20005,360,800<disabled>
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Paragraph IV activity for: LOTRONEX

Drugname Dosage Strength RLD Submissiondate
alosetron hydrochlorideTablets0.5 mg and 1 mgLotronex12/2/2010
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