QSYMIA (nda022580)- (EQ 3.75MG BASE;23MG,EQ 7.5MG BASE;46MG,EQ 11.25MG BASE;69MG,EQ 15MG BASE;92MG)

Generic Name	PHENTERMINE HYDROCHLORIDE; TOPIRAMATE	Innovator	VIVUS LLC
Dosage	EQ 3.75MG BASE;23MG,EQ 7.5MG BASE;46MG,EQ 11.25MG BASE;69MG,EQ 15MG BASE;92MG
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2029-Jun-14	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	QSYMIA is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate, indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in: • Adults with an initial body mass index (BMI) of: o 30 kg/m2 or greater (obese) or o 27 kg/m2 or greater (overweight) in the presence of at least one weightrelated comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia • Pediatric patients aged 12 years and older with BMI in the 95th percentile or greater standardized for age and sex.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	0

Other Developers

Total Other Developers	5

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 3.75MG BASE;23MG	**	**	-	-	-
EQ 7.5MG BASE;46MG	**	**	-	-	-
EQ 11.25MG BASE;69MG	**	**	-	-	-
EQ 15MG BASE;92MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of QSYMIA