Novartis petitions FDA to block 18 generic competitors for its megablockbuster heart drug until 2024

No­var­tis is look­ing to milk one of its most prized pos­ses­sions a lit­tle while longer with­out any gener­ic com­pe­ti­tion, most­ly be­cause of a new­ly ap­proved use that the Big Phar­ma won ear­li­er this year for its megablock­buster heart drug En­tresto.

In ad­di­tion to bat­tling (and win­ning) lit­i­ga­tion last month to block a hand­ful of In­di­an gener­ics from en­ter­ing the mar­ket ear­ly along­side En­tresto, the com­pa­ny last week pe­ti­tioned the FDA to try to stop a to­tal of 18 En­tresto gener­ics from launch­ing be­fore 2024 at the ear­li­est.

Un­der No­var­tis’ read­ing of FDA’s ‘same la­bel­ing’ reg­u­la­tions, the com­pa­ny con­tends that ‘the agency can­not ap­prove an AN­DA [gener­ic drug] seek­ing to omit the patent- and ex­clu­siv­i­ty-pro­tect­ed use un­til ex­pi­ra­tion of the ex­clu­siv­i­ty in Feb­ru­ary 2024 – and even then, on­ly if the AN­DA ap­pli­cants sub­mit a para­graph IV cer­ti­fi­ca­tion to each of the HF­pEF Patents.’

While such pe­ti­tions to FDA are of­ten de­nied, and No­var­tis un­der­stands that gener­ics will eat away at its mas­sive sales for En­tresto soon-ish, many com­pa­nies of­ten file the FDA pe­ti­tions any­way in an at­tempt to fur­ther de­lay gener­ics.

No­var­tis has al­ready sued gener­ic drug­mak­ers look­ing to bring copy­cats of En­tresto to mar­ket in Ju­ly 2023, which is when a reg­u­la­to­ry stay on FDA’s au­thor­i­ty to grant fi­nal ap­proval to these AN­DAs will lift. Oth­er law­suits are al­so cur­rent­ly pend­ing, and a tri­al in the Delaware dis­trict court has been sched­uled to start on Sept. 8, 2022. No­var­tis al­so filed oth­er law­suits against cer­tain gener­ic com­pa­nies in Sep­tem­ber and Oc­to­ber that were tar­get­ing three oth­er patents, one of which doesn’t ex­pire un­til 2036.

En­tresto won its first FDA ap­proval in the HFrEF pop­u­la­tion in Ju­ly 2015 and hauled in al­most $2.5 bil­lion in sales in 2020, and an­oth­er $2.6 bil­lion in the first nine months of 2021.

Back in Feb­ru­ary, the FDA al­so ap­proved En­tresto as the first and on­ly ther­a­py in the US to treat pa­tients di­ag­nosed with heart fail­ure, in­clud­ing both those with heart fail­ure with re­duced ejec­tion frac­tion (HFrEF) and with heart fail­ure with pre­served ejec­tion frac­tion (HF­pEF). That means that of the more than 6 mil­lion Amer­i­cans suf­fer­ing from chron­ic heart fail­ure, about 5 mil­lion may be ap­pro­pri­ate for treat­ment with En­tresto, the com­pa­ny con­tend­ed.

That new use for En­tresto is al­so pro­tect­ed by three more years of ex­clu­siv­i­ty, which could amount to bil­lions more for the com­pa­ny.

No­var­tis told FDA that a gener­ic com­peti­tor seek­ing ap­proval be­fore the ex­pi­ra­tion of En­tresto’s ex­clu­siv­i­ty must pro­pose la­bel­ing that omits the ex­clu­siv­i­ty-pro­tect­ed con­di­tions of ap­proval and does not dis­close the patent­ed use, adding:

An AN­DA ap­pli­cant may on­ly seek ap­proval for the con­di­tions of use that ex­ist­ed in the En­tresto la­bel­ing pri­or to Feb­ru­ary 2021, i.e., to re­duce the risk of car­dio­vas­cu­lar death and hos­pi­tal­iza­tion for heart fail­ure in pa­tients with chron­ic heart fail­ure and re­duced ejec­tion frac­tion. How­ev­er, there is no per­mis­si­ble way for AN­DA ap­pli­cants to draft an in­di­ca­tion state­ment for use in pa­tients with re­duced ejec­tion frac­tion by delet­ing words or mak­ing de min­imis changes to the ex­ist­ing in­di­ca­tion state­ment.
https://endpts.com/novartis-petitions-fda-to-block-18-generic-competitors-for-its-megablockbuster-heart-drug-until-2024/