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Re: DewDiligence post# 158693

Monday, 06/24/2013 4:10:46 PM

Monday, June 24, 2013 4:10:46 PM

Post# of 257257
AGN falls sharply on prospects for generic Restasis in US:

http://blogs.marketwatch.com/health-exchange/2013/06/24/fdas-guidance-to-generic-rivals-for-eye-drug-sends-allergan-reeling/

AGN’s longstanding contention that a Restatis ANDA filer would need to run clinical trials to gain approval never rang true, IMO. (It reminded me of Teva’s similar contention with respect to generic Copaxone.)

Restatis is AGN’s second-biggest drug after Botox, so the timing of US generic competition matters a lot. The Orange Book patent on Restasis expires in May 2014 (http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=050790&Product_No=001&table1=OB_Rx ).

p.s. Botox itself could soon face increased competition—see #msg-85982909.

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