POMALYST (nda204026)- (1MG,2MG,3MG,4MG)

Generic Name	POMALIDOMIDE	Innovator	BRISTOL
Dosage	1MG,2MG,3MG,4MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2031-Dec-21	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	POMALYST is a thalidomide analogue indicated, for the treatment of adult patients:  in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.  with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
4	1	0

Other Developers

Total Other Developers	5

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
1MG	**	**	-	-	-
2MG	**	**	-	-	-
3MG	**	**	-	-	-
4MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of POMALYST