Thursday, December 07, 2006

Sun Pharma Files Para IV Challenge for Anti-cancer Gemzar

Eli Lilly early this month has sued Mumbai-based Sun Pharmaceutical Industries in a move to negate Para IV challenge against Lilly’s blockbuster anti-cancer drug Gemzar, generically known as Gemcitabine hydrochloride worth around US $ 586 million US sales in 2005 (source Eli Lilly Annual Report 2005). Sun, which recently filed an abbreviated new drug application with the US FDA under Para IV certification, claims Orange Book listed patents --- U.S. Patent # 4,808,614 (the ‘614 patent) expiring on November 15, 2010 and U.S. Patent # 5,464,826 (the ‘826 patent) expiring on May 07, 2013 --- to be invalid and non-infringed. Early in January 2006, Sicor Pharmaceuticals, Inc. (a subsidiary of Teva) submitted an abbreviated new drug application with the US FDA seeking marketing approval for generic version of Gemzar, claiming both Orange Book patents to be invalid and non-infringed. Subsequently in February 2006, Lilly filed a patent infringement lawsuit against Sicor in the U.S. District Court for the Southern District of Indiana. (Eli Lilly & Co. v. Sicor Pharmaceuticals, Inc. et al insdce 1:2006cv00238 2/15/2006).


  1. Anonymous2:06 AM

    black mold exposureblack mold symptoms of exposurewrought iron garden gatesiron garden gates find them herefine thin hair hairstylessearch hair styles for fine thin hairnight vision binocularsbuy night vision binocularslipitor reactionslipitor allergic reactionsluxury beach resort in the philippines

    afordable beach resorts in the philippineshomeopathy for big with great mineral makeup bargainsmineral makeup wholesalersprodam iphone Apple prodam iphone prahacect iphone manualmanual for P 168 iphonefero 52 binocularsnight vision Fero 52 binocularsThe best night vision binoculars here

    night vision binoculars bargainsfree photo albums computer programsfree software to make photo albumsfree tax formsprintable tax forms for free craftmatic air bedcraftmatic air bed adjustable info hereboyd air bedboyd night air bed lowest pricefind air beds in wisconsinbest air beds in wisconsincloud air beds

    best cloud inflatable air bedssealy air beds portableportables air bedsrv luggage racksaluminum made rv luggage racksair bed raisedbest form raised air bedsaircraft support equipmentsbest support equipments for aircraftsbed air informercialsbest informercials bed airmattress sized air beds

    bestair bed mattress antique doorknobsantique doorknob identification tipsdvd player troubleshootingtroubleshooting with the dvd playerflat panel television lcd vs plasmaflat panel lcd television versus plasma pic the bestThe causes of economic recessionwhat are the causes of economic recessionadjustable bed air foam The best bed air foam

    hoof prints antique equestrian printsantique hoof prints equestrian printsBuy air bedadjustablebuy the best adjustable air bedsair beds canadian storesCanadian stores for air beds

    migraine causemigraine treatments floridaflorida headache clinicdrying dessicantair drying dessicantdessicant air dryerpediatric asthmaasthma specialistasthma children specialistcarpet cleaning dallas txcarpet cleaners dallascarpet cleaning dallas