BRILINTA (nda022433)- (60MG,90MG)

Generic Name	TICAGRELOR	Innovator	ASTRAZENECA
Dosage	60MG,90MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2036-Jul-27	NCE Excl Expiry	2016-Jul-20
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	BRILINTA is a P2Y12 platelet inhibitor indicated • to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. • to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of BRILINTA was established in a population with type 2 diabetes mellitus (T2DM). • to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
6	10	0

Other Developers

Total Other Developers	25

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
60MG	**	**	Up	-	-
90MG	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of BRILINTA