VERAPAMIL HYDROCHLORIDE (nda018925)- (5MG/2ML (2.5MG/ML),10MG/4ML (2.5MG/ML))

Generic Name	VERAPAMIL HYDROCHLORIDE	Innovator	EXELA PHARMA
Dosage	5MG/2ML (2.5MG/ML),10MG/4ML (2.5MG/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Verapamil is indicated for the treatment of supraventricular tachyarrhythmias, including: • Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [WPW] and Lown-Ganong-Levine [LGL] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to Verapamil administration. • Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation, except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White [WPW] and Lown-Ganong-Levine [LGL] syndromes).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
7	0	5

Other Developers

Total Other Developers	48

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
5MG/2ML (2.5MG/ML)	**	**	-	-	-
10MG/4ML (2.5MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	5

Manufacturing Details of VERAPAMIL HYDROCHLORIDE