ELIQUIS SPRINKLE (NDA220073)- (0.15MG)

Generic Name	APIXABAN	Innovator	BRISTOL
Dosage	0.15MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2041-May-22	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2028-Apr-17
GAIN Expiry	None	Drug Complexity	No
Indication	ELIQUIS is a factor Xa inhibitor indicated:  to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.  for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery.  for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE in adult patients following initial therapy.  Treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.15MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ELIQUIS SPRINKLE