FORTEO (nda021318)- (0.6MG/2.4ML (0.25MG/ML),0.75MG/3ML (0.25MG/ML))

Generic Name	TERIPARATIDE	Innovator	LILLY
Dosage	0.6MG/2.4ML (0.25MG/ML),0.75MG/3ML (0.25MG/ML)
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2025-Mar-25	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	FORTEO is a parathyroid hormone analog, (PTH 1-34), indicated for: • Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy • Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy • Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	0	2

Other Developers

Total Other Developers	24

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.6MG/2.4ML (0.25MG/ML)	**	**	Up	-	1
0.75MG/3ML (0.25MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	1

Manufacturing Details of FORTEO