OTEZLA XR (NDA210745)- (10MG,20MG,75MG)

Generic Name	APREMILAST	Innovator	AMGEN INC
Dosage	10MG,20MG,75MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2042-May-27	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	OTEZLA/OTEZLA XR, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: Adult patients with: • Active psoriatic arthritis • Plaque psoriasis who are candidates for phototherapy or systemic therapy • Oral ulcers associated with Behçet’s Disease. Pediatric patients 6 years of age and older with: • Active psoriatic arthritis • Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. In the pediatric population, OTEZLA is indicated for patients weighing at least 20 kg, and OTEZLA XR is indicated for patients weighing at least 50 kg.

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
10MG	**	**	-	-	-
20MG	**	**	-	-	-
75MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of OTEZLA XR