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 22^nd, 2016.

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Summary for LOTRONEX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	158
Patent Applications:	1,531
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LOTRONEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LOTRONEX
What excipients (inactive ingredients) are in LOTRONEX?	LOTRONEX excipients list
DailyMed Link:	LOTRONEX at DailyMed

Drug patent expirations by year for LOTRONEX

Pharmacology for LOTRONEX

Drug Class	Serotonin-3 Receptor Antagonist
Mechanism of Action	Serotonin 3 Receptor Antagonists

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

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Glossary

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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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	021107-001	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.

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Country	Patent Number	Title	Estimated Expiration
Portugal	88409	PROCESSO PARA A PREPARACAO DE LACTAMAS TRICICLICAS	⤷ Sign Up
Australia	2174288		⤷ Sign Up
Ireland	61669	Lactam derivatives	⤷ Sign Up
Israel	135398		⤷ Sign Up
Hungary	211843		⤷ Sign Up
Canada	2305751		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for LOTRONEX

Pharmacology for LOTRONEX

Paragraph IV (Patent) Challenges for LOTRONEX

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