FOLOTYN (nda022468)- (20MG/ML (20MG/ML),40MG/2ML (20MG/ML))

Generic Name	PRALATREXATE	Innovator	ACROTECH BIOPHARMA
Dosage	20MG/ML (20MG/ML),40MG/2ML (20MG/ML)
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2025-May-31	NCE Excl Expiry	2014-Sep-24
ODE Expiry	2016-Sep-24	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	FOLOTYN is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	1	0

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
20MG/ML (20MG/ML)	**	**	-	-	-
40MG/2ML (20MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of FOLOTYN