REVLIMID (nda021880)- (2.5MG,5MG,10MG,15MG,20MG,25MG)

Generic Name	LENALIDOMIDE	Innovator	BRISTOL MYERS SQUIBB
Dosage	2.5MG,5MG,10MG,15MG,20MG,25MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2028-Mar-08	NCE Excl Expiry	2010-Dec-27
ODE Expiry	2013-Jun-29	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with:  Multiple myeloma (MM), in combination with dexamethasone.  MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).  Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.  Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.  Previously treated follicular lymphoma (FL), in combination with a rituximab product.  Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
14	1	11

Other Developers

Total Other Developers	13

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
2.5MG	**	**	-	-	-
5MG	**	**	-	-	-
10MG	**	**	-	-	-
15MG	**	**	-	-	-
20MG	**	**	-	-	-
25MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	10

Manufacturing Details of REVLIMID