ZENBEXUS (NDA221075)- (EQ 0.75MG BASE,EQ 1MG BASE)

Generic Name	IBERDOMIDE HYDROCHLORIDE	Innovator	BRISTOL MYERS SQUIBB
Dosage	EQ 0.75MG BASE,EQ 1MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2039-Sep-30	NCE Excl Expiry	2031-Aug-13
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ZENBEXUS is a cereblon-modulating protein degrader indicated in combination with daratumumab and hyaluronidase-fihj and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. (1) This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete response (CR) at any time. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 0.75MG BASE	**	**	-	-	-
EQ 1MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ZENBEXUS