PROTOPIC (nda050777)- (0.03%,0.1%)

Generic Name	TACROLIMUS	Innovator	LEO PHARMA AS
Dosage	0.03%,0.1%
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2014-Sep-09	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	PROTOPIC Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
4	0	3

Other Developers

Total Other Developers	11

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.03%	**	**	Down	-	3
0.1%	**	**	Down	-	3

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	3

Manufacturing Details of PROTOPIC