XOPENEX (nda020837)- (EQ 0.021% BASE,EQ 0.042% BASE,EQ 0.0103% BASE,EQ 0.25% BASE)

Generic Name	LEVALBUTEROL HYDROCHLORIDE	Innovator	HIKMA
Dosage	EQ 0.021% BASE,EQ 0.042% BASE,EQ 0.0103% BASE,EQ 0.25% BASE
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2021-Mar-21	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	XOPENEX (levalbuterol hydrochloride) Inhalation Solution Concentrate is a beta2-adrenergic agonist indicated for: • Treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
10	0	8

Other Developers

Total Other Developers	8

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 0.021% BASE	**	**	-	-	2
EQ 0.042% BASE	**	**	-	-	2
EQ 0.0103% BASE	**	**	-	-	2
EQ 0.25% BASE	**	**	-	-	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	8

Manufacturing Details of XOPENEX