LOTRONEX (nda021107)- (EQ 1MG BASE,EQ 0.5MG BASE)

Generic Name	ALOSETRON HYDROCHLORIDE	Innovator	SEBELA IRELAND LTD
Dosage	EQ 1MG BASE,EQ 0.5MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2018-Oct-05	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	LOTRONEX is a selective serotonin 5-HT3 antagonist indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: • chronic IBS symptoms (generally lasting 6 months or longer), • had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and • not responded adequately to conventional therapy. Severe IBS includes diarrhea and 1 or more of the following: • frequent and severe abdominal pain/discomfort, • frequent bowel urgency or fecal incontinence, • disability or restriction of daily activities due to IBS.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
5	0	5

Other Developers

Total Other Developers	3

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 1MG BASE	**	**	Down	-	3
EQ 0.5MG BASE	**	**	Down	3	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	5

Manufacturing Details of LOTRONEX