This starts the clock on the 30-month stay of FDA approval of generic Truvada.
Technically, Teva’s P-IV challenge is against GILD’s US patents on Emtriva, one of the two constituent drugs in Truvada; however, Emtriva is hardly ever used other than as a component in Truvada and hence it makes much more sense for Teva to submit an ANDA for Truvada (as it has done) rather than an ANDA for Emtriva.
How Teva expects to get around GILD’s patent on Viread, the other constituent of Truvada, is unclear.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”