BYETTA (nda021773)- (300MCG/1.2ML (250MCG/ML),600MCG/2.4ML (250MCG/ML))

Generic Name	EXENATIDE SYNTHETIC	Innovator	ASTRAZENECA AB
Dosage	300MCG/1.2ML (250MCG/ML),600MCG/2.4ML (250MCG/ML)
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2020-Jan-14	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	1

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
300MCG/1.2ML (250MCG/ML)	**	**	Up	-	-
600MCG/2.4ML (250MCG/ML)	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of BYETTA