History Oseltamivir

plate françois-pierre chaumeton s 1833 flore medicale

oseltamivir discovered scientists @ gilead using shikimic acid starting point synthesis; shikimic acid available extract of chinese star anise 2006 30% of supply manufactured recombinantly in e. coli. gilead exclusively licensed relevant patents roche in 1996. drug´s patent has not been protected in thailand, philippines, indonesia, , several other countries.

in 1999, fda approved oseltamivir phosphate treatment of influenza in adults based on 2 double-blinded, randomized, placebo-controlled clinical trials. in june 2002 ema approved oseltamivir phosphate prophylaxis , treatment of influenza. in 2003 pooled analysis of 10 randomised clinical trials concluded oseltamivir reduced risk of lower respiratory tract infections resulting in antibiotic use , hospital admissions in adults.

oseltamivir (as tamiflu) used during h5n1 avian influenza epidemic in southeast asia in 2005. in response epidemic, various governments – including of united kingdom, canada, israel, united states, , australia – stockpiled quantities of oseltamivir in preparation possible pandemic , there worldwide shortages of drug, driven high demand stockpiling. in november 2005, u.s. president george w. bush requested congress fund us$1 billion production , stockpile of oseltamivir, after congress had approved $1.8 billion military use of drug. defense secretary rumsfeld recused himself government decisions regarding drug.

in 2006, cochrane review raised controversy concluding oseltamivir should not used during routine seasonal influenza because of low effectiveness.

in december 2008, indian drug company, cipla won case in india s court system allowing manufacture cheaper generic version of tamiflu, called antiflu. in may 2009, cipla won approval certifying drug antiflu effective tamiflu, , antiflu included in list of prequalified medicinal products.

marketing display used @ festivals features person living in hermetically sealed environment

in 2009, new a/h1n1 influenza virus discovered spreading in north america. in june 2009 declared a/h1n1 influenza pandemic. nice, cdc, who, , european centre disease prevention maintained recommendation use oseltamivir.

from 2010 2012, cochrane requested roche´s full clinical study reports of trials, did not provide. in 2011, freedom of information request european medicines agency provided cochrane reports 16 roche oseltamivir trials. in 2012, cochrane team published interim review based on reports. in 2013, roche released 77 full clinical study reports of oseltamivir trials, after gsk released data on zanamivir studies. , in 2014, cochrane published updated review based solely on full clinical study reports , regulatory documents.

in 2016, roche´s patents of oseltamivir began expire.