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Generics

Set Alert for Generics

Teva Sees COVID Sales Correction

In a busy second quarter for Teva, a COVID-19 slump acted as a correction to the related boost in demand seen in the first quarter of 2020.

Sales & Earnings Strategy

Who’s Hired? ANI Names New CEO

ANI Pharmaceuticals has chosen its new president and CEO to replace interim chief Patrick Walsh who stepped in after the departure Arthur Przybyl earlier this year. Meanwhile, key personnel announcements have also been made by Teva and Mylan.

Appointments Strategy

Trio Face 11 Year Wait On Eliquis As US Patents Upheld

Three ANDA sponsors – HEC’s Sunshine Lake, Sigmapharm and Unichem – for generic versions of Eliquis had elected to take their Hatch-Waxman case to trial but were soundly beaten by originator’s Bristol-Myers Squibb and Pfizer. A launch in 2031 could now be their best, and only, option.

Legal Issues Intellectual Property

Rosemont Deal Shows Value Is Out There For US Exit, Perrigo Says

Perrigo management provided colorful commentary on Perrigo’s latest endeavors to separate the company’s US generics business, following the recent sale of Perrigo’s Rosemont Pharmaceuticals subsidiary for an “attractive” multiple.

Generic Drugs M & A

FDA Expedites ANDA Postapproval Manufacturing Changes

Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.

User Fees Generic Drugs

Amarin Makes Vascepa Generics Prediction And Questions Supply

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.

Generic Drugs Legal Issues
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