PRADAXA (nda022512)- (EQ 75MG BASE,EQ 150MG BASE,EQ 110MG BASE)

Generic Name	DABIGATRAN ETEXILATE MESYLATE	Innovator	BOEHRINGER INGELHEIM
Dosage	EQ 75MG BASE,EQ 150MG BASE,EQ 110MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2031-Jul-20	NCE Excl Expiry	2015-Oct-19
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	PRADAXA Capsules is a direct thrombin inhibitor indicated: • To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation • For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days • To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated • For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery • For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days • To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
5	6	5

Other Developers

Total Other Developers	20

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 75MG BASE	**	**	Down	-	5
EQ 150MG BASE	**	**	Down	-	5
EQ 110MG BASE	**	**	-	-	4

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	3

Manufacturing Details of PRADAXA