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Last Updated: November 2, 2024

LOTRONEX Drug Patent Profile


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Which patents cover Lotronex, and when can generic versions of Lotronex launch?

Lotronex is a drug marketed by Sebela Ireland Ltd and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Lotronex

A generic version of LOTRONEX was approved as alosetron hydrochloride by AMNEAL PHARMS on December 22nd, 2016.

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Drug patent expirations by year for LOTRONEX
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Pharmacology for LOTRONEX
Paragraph IV (Patent) Challenges for LOTRONEX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LOTRONEX Tablets alosetron hydrochloride 0.5 mg and 1 mg 021107 1 2010-12-02

US Patents and Regulatory Information for LOTRONEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sebela Ireland Ltd LOTRONEX alosetron hydrochloride TABLET;ORAL 021107-002 Dec 23, 2003 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sebela Ireland Ltd LOTRONEX alosetron hydrochloride TABLET;ORAL 021107-001 Feb 9, 2000 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LOTRONEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd LOTRONEX alosetron hydrochloride TABLET;ORAL 021107-001 Feb 9, 2000 ⤷  Sign Up ⤷  Sign Up
Sebela Ireland Ltd LOTRONEX alosetron hydrochloride TABLET;ORAL 021107-002 Dec 23, 2003 ⤷  Sign Up ⤷  Sign Up
Sebela Ireland Ltd LOTRONEX alosetron hydrochloride TABLET;ORAL 021107-001 Feb 9, 2000 ⤷  Sign Up ⤷  Sign Up
Sebela Ireland Ltd LOTRONEX alosetron hydrochloride TABLET;ORAL 021107-002 Dec 23, 2003 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for LOTRONEX

See the table below for patents covering LOTRONEX around the world.

Country Patent Number Title Estimated Expiration
South Korea 20010015707 ⤷  Sign Up
Ireland 61669 Lactam derivatives ⤷  Sign Up
Japan 2602915 ⤷  Sign Up
Japan H02167280 LACTAM DERIVATIVE ⤷  Sign Up
New Zealand 226032 2-(IMIDAZOLYLMETHYL)-PYRIDO OR-AZEPINO(4,3-B)INDOLE-1(2H)-ONE DERIVATIVES; PREPARATORY PROCESSES AND PHARMACEUTICAL COMPOSITIONS ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.