1. Generics Bulletin
  2. >>Products

Amarin Makes Vascepa Generics Prediction And Questions Supply

Federal Circuit Decision Anticipated Late 2020 Or Early 2021

 
• By Dean Rudge

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.

Crystal ball
Amarin is gearing up oral hearing of the Federal Circuit case on 2 September • Source: Shutterstock

Amarin does not anticipate Hikma or Dr Reddy's to introduce generic Vascepa (icosapent ethyl) until the US Court of Appeals for the Federal Circuit decides on Amarin’s appeal over the generics sponsors’ patent-litigation victories – and only then with a “limited supply,” according to the originator’s president and CEO, John Thero.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Generics

More from Products

Polpharma Looks To Supercharge Biosimilar Development With Help Of Chime

 
• By Dean Rudge

With six biosimilars reportedly in development, Polpharma Biologics has linked up with Chinese CDMO Chime Biologics, looking to tap its “all-in-one solutions to accelerate biosimilar development and reduce the time-to-market” for an undisclosed biosimilar product.

Cardinal Looks Ahead To A New Decade For US Biosimilars

 
• By Dave Wallace

In the wake of a report marking 10 years since the first US biosimilar launch, Cardinal Health’s Dracey Poore speaks to Generics Bulletin about the successes seen so far and the obstacles that must be overcome if the market is to thrive in the decade ahead.

Regulatory Recap: UK To Capture £1bn Savings With Framework For Best-Value Biologics

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.