WEGOVY (nda215256)- (0.25MG/0.5ML (0.25MG/0.5ML),0.5MG/0.5ML (0.5MG/0.5ML),1MG/0.5ML (1MG/0.5ML),1.7MG/0.75ML (1.7MG/0.75ML),2.4MG/0.75ML (2.4MG/0.75ML))

Generic Name	SEMAGLUTIDE	Innovator	NOVO
Dosage	0.25MG/0.5ML (0.25MG/0.5ML),0.5MG/0.5ML (0.5MG/0.5ML),1MG/0.5ML (1MG/0.5ML),1.7MG/0.75ML (1.7MG/0.75ML),2.4MG/0.75ML (2.4MG/0.75ML)
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2041-Feb-17	NCE Excl Expiry	2022-Dec-05
ODE Expiry	None	NP Expiry	2024-Jun-04
GAIN Expiry	None	Drug Complexity	No
Indication	WEGOVY is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in: • adult patients with an initial body mass index (BMI) of o 30 kg/m2 or greater (obesity) or o 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). • pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and sex (obesity).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	18

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.25MG/0.5ML (0.25MG/0.5ML)	**	**	Down	-	-
0.5MG/0.5ML (0.5MG/0.5ML)	**	**	Down	-	-
1MG/0.5ML (1MG/0.5ML)	**	**	Up	-	-
1.7MG/0.75ML (1.7MG/0.75ML)	**	**	Up	-	-
2.4MG/0.75ML (2.4MG/0.75ML)	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of WEGOVY