CIPRO (nda019537)- (EQ 250MG BASE,EQ 500MG BASE,EQ 750MG BASE)

Generic Name	CIPROFLOXACIN HYDROCHLORIDE	Innovator	BAYER HLTHCARE
Dosage	EQ 250MG BASE,EQ 500MG BASE,EQ 750MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2011-Aug-15	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	CIPRO is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: • Skin and Skin Structure Infections • Bone and Joint Infections • Complicated Intra-Abdominal Infections • Infectious Diarrhea • Typhoid Fever (Enteric Fever) • Uncomplicated Cervical and Urethral Gonorrhea • Inhalational Anthrax post-exposure in adult and pediatric patients • Plague in adult and pediatric patients • Chronic Bacterial Prostatitis • Lower Respiratory Tract Infections: Acute Exacerbation of Chronic Bronchitis • Urinary Tract Infections: Urinary Tract Infections (UTI), Acute Uncomplicated Cystitis, Complicated UTI and Pyelonephritis in Pediatric Patients • Acute Sinusitis.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
12	0	10

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 250MG BASE	**	**	-	8	1
EQ 500MG BASE	**	**	-	-	9
EQ 750MG BASE	**	**	-	-	7

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	8

Manufacturing Details of CIPRO