ALOSETRON HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for alosetron hydrochloride and what is the scope of patent protection?

Alosetron hydrochloride is the generic ingredient in two branded drugs marketed by Amneal Pharms, Endo Operations, Eywa Pharma, Hikma, Mankind Pharma, Rising, and Sebela Ireland Ltd, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for alosetron hydrochloride. Seven suppliers are listed for this compound.

Summary for ALOSETRON HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	5
Patent Applications:	281
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALOSETRON HYDROCHLORIDE
What excipients (inactive ingredients) are in ALOSETRON HYDROCHLORIDE?	ALOSETRON HYDROCHLORIDE excipients list
DailyMed Link:	ALOSETRON HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ALOSETRON HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
GlaxoSmithKline	Phase 4
Hadassah Medical Organization	Phase 1
GlaxoSmithKline	Phase 2

See all ALOSETRON HYDROCHLORIDE clinical trials

Pharmacology for ALOSETRON HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for ALOSETRON HYDROCHLORIDE

A03AE	Serotonin receptor antagonists
A03A	DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
A03	DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for ALOSETRON HYDROCHLORIDE

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 ALOSETRON HYDROCHLORIDE

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	021107-001	Feb 9, 2000	AB	RX	Yes	Yes
Mankind Pharma	ALOSETRON HYDROCHLORIDE	alosetron hydrochloride	TABLET;ORAL	213614-001	Sep 9, 2020	AB	RX	No	No
Rising	ALOSETRON HYDROCHLORIDE	alosetron hydrochloride	TABLET;ORAL	209180-001	Jan 14, 2019	AB	RX	No	No
Sebela Ireland Ltd	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-002	Dec 23, 2003	AB	RX	Yes	No
Hikma	ALOSETRON HYDROCHLORIDE	alosetron hydrochloride	TABLET;ORAL	200652-002	May 4, 2015		DISCN	No	No
Amneal Pharms	ALOSETRON HYDROCHLORIDE	alosetron hydrochloride	TABLET;ORAL	206647-002	Dec 22, 2016	AB	RX	No	No
Eywa Pharma	ALOSETRON HYDROCHLORIDE	alosetron hydrochloride	TABLET;ORAL	211621-002	Sep 16, 2019		DISCN	No	No

Expired US Patents for ALOSETRON HYDROCHLORIDE

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
Sebela Ireland Ltd	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-002	Dec 23, 2003
Sebela Ireland Ltd	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-001	Feb 9, 2000
Sebela Ireland Ltd	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-002	Dec 23, 2003