Dr Reddy’s Pounces On US Ciprodex Generic As Endo Stumbles
Follows Expiry Of Key Ciprodex Patents
Dr Reddy’s Laboratories has leapfrogged Endo by launching a generic version of of Bayer/Alcon’s Ciprodex (ciprofloxacin/dexamethasone) 0.3%/0.1% otic suspension, as the US firm was stung with a major rejection by the US FDA.
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Under the terms of a patent-litigation settlement from April 2017, Endo’s Par subsidiary has launched the first US generic versions of BioMarin’s Kuvan (sapropterin) tablet and powder formulations. Rival ANDA sponsor Dr Reddy’s has followed suit on the tablet formulation.
After seeing increased demand because of COVID-19 in the first quarter of 2020, Endo’s generics segment has seen a predicted decrease in revenues in the second quarter. Furthermore, the company has also predicted an unfavorable impact due to competitive pressures for 2020 as a whole.
Amarin – and the industry at large – was stunned in March this year when Hikma and Dr Reddy’s walked away from court with an invalidity ruling against six Vascepa patents in the US. The originator’s CEO gave an impassioned update on the current state of play, including the potential for generics to launch ahead of a Federal Circuit ruling later this year or early in 2021.