ZEPBOUND (AUTOINJECTOR) (NDA217806)- (2.5MG/0.5ML (2.5MG/0.5ML),2.5MG/0.5ML (2.5MG/0.5ML),5MG/0.5ML (5MG/0.5ML),5MG/0.5ML (5MG/0.5ML),7.5MG/0.5ML (7.5MG/0.5ML),7.5MG/0.5ML (7.5MG/0.5ML),10MG/0.5ML (10MG/0.5ML),10MG/0.5ML (10MG/0.5ML),12.5MG/0.5ML (12.5MG/0.5ML),12.5MG/0.5ML (12.5MG/0.5ML),15MG/0.5ML (15MG/0.5ML),15MG/0.5ML (15MG/0.5ML))

Generic Name	TIRZEPATIDE	Innovator	ELI LILLY AND CO
Dosage	2.5MG/0.5ML (2.5MG/0.5ML),2.5MG/0.5ML (2.5MG/0.5ML),5MG/0.5ML (5MG/0.5ML),5MG/0.5ML (5MG/0.5ML),7.5MG/0.5ML (7.5MG/0.5ML),7.5MG/0.5ML (7.5MG/0.5ML),10MG/0.5ML (10MG/0.5ML),10MG/0.5ML (10MG/0.5ML),12.5MG/0.5ML (12.5MG/0.5ML),12.5MG/0.5ML (12.5MG/0.5ML),15MG/0.5ML (15MG/0.5ML),15MG/0.5ML (15MG/0.5ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2039-Jun-14	NCE Excl Expiry	2027-May-13
ODE Expiry	None	NP Expiry	2026-Nov-08
GAIN Expiry	None	Drug Complexity	No
Indication	ZEPBOUND™ is a glucose-dependent insulinotropic polypeptide (GIP) receptor and 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 adults with an initial body mass index (BMI) of: • 30 kg/m2 or greater (obesity) or • 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease)

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
2.5MG/0.5ML (2.5MG/0.5ML)	**	**	-	-	-
5MG/0.5ML (5MG/0.5ML)	**	**	-	-	-
7.5MG/0.5ML (7.5MG/0.5ML)	**	**	-	-	-
10MG/0.5ML (10MG/0.5ML)	**	**	-	-	-
12.5MG/0.5ML (12.5MG/0.5ML)	**	**	-	-	-
15MG/0.5ML (15MG/0.5ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ZEPBOUND (AUTOINJECTOR)