ZYPREXA ZYDIS (nda021086)- (5MG,10MG,15MG,20MG)

Generic Name	OLANZAPINE	Innovator	CHEPLAPHARM
Dosage	5MG,10MG,15MG,20MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2017-Nov-01	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ZYPREXA ZYDIS® (olanzapine) is an atypical antipsychotic indicated: As oral formulation for the: • Treatment of schizophrenia. • Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. • Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. • Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
14	0	10

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
5MG	**	**	-	-	8
10MG	**	**	-	-	8
15MG	**	**	-	-	8
20MG	**	**	-	-	8

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	8

Manufacturing Details of ZYPREXA ZYDIS