A	B	C
1	Main
2		Brand Name	Plavix
3		Generic Name	clopidogrel
4		Indication	Antithrombotic mostly used in patients with heart attack, stroke, PAD or in conjunction with stenting. Chronic use for prevention of chronic heart disease.
5			Aspirin inhibits the thromboxane-A synthase pathway. Plavix inhibits adenosine diphosphate (ADP).
6		Mechanism	Antiplatelet that inhibits the aggregation of platelets, suppressing the formation of blood clots.
7		Market	Drug-eluting stent panic may increase duration of Plavix use.
8		Competition	Prasugrel.
9		IP	expires 5/17/2012
10			European at-risk filer Schweizerhall -- Germany -- different salt form.
11			Bristol and Plavix innovator Sanofi-Aventis vs. Apotex (private Candian co) and Dr. Reddy's Labs
12			Patent 4,847,265 in question. SNY has said additional Orange Book patents irrelevant
13			Is Plavix novel? (validity)
14			Was the patent appropriately acquired? (enforceability)
15			Racemic mix patent (4,529,596)
16			Single isomer patent ('265)
17			Single isomer acts differently from '596.
18			No prior art kept from patent examiner, so inequitable conduct argument is weak.
19			Single isomer precedents?
20			Levaquin upheld vs. Mylan
21			Judge Stein ruled against Purdue and for Endo before--but Endo waited for launch because the case wasn’t clear--treble damages.
22			Same thing could happen here. FDA definition of when the 180-day window starts will confuse this further.
23			Case began 1/22/2007. '265 patent likely valid & enforceable - comments from Judge Stein
24		Clinical Trials
25			CURRENT OASIS 7
26			n=18,000 High dose vs low dose Plavix.