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Five More Circle Tecfidera With Ruling 'Unlikely To Be Reversed'

Delaware Decision Allows ANDA Sponsors To Launch

 
• By Dean Rudge

With a federal district court decision opening the door for a multitude of generic Tecfidera products, the market has reacted, suggesting as many as five ANDA products are primed for launch.

Target
As many as five Tecfidera ANDA sponsors are targeting launch, it has been claimed • Source: Shutterstock

The US market for Biogen’s Tecfidera (dimethyl fumarate) blockbuster is to be commoditized, with four or five additional generic sponsors now seeking final approval and launch following a Delaware district court decision that has paved the way for further competition, a US healthcare investor has claimed.

A federal district court in Delaware has just decided that it was bound by an invalidity ruling obtained by

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US Supreme Court Requests Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

The US Supreme Court is seeking a brief “expressing the views of the United States,” following the US Federal Circuit’s decision to reopen Amarin’s claim of induced infringement against Hikma relating to its ‘skinny-label’ generic Vascepa (icosapent ethyl) product.

Viatris Targets Gilead’s Odefsey HIV Blockbuster In Europe With CHMP Recommendation

 
• By Dean Rudge

Viatris has secured two positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use for generics to two blockbusters: Gilead’s HIV drug Odefsey and Boehringer’s IPF treatment Ofev, with a path to approvals possible in 67 days.

AAM Celebrates Court Backing Over Minnesota Pricing Law

 
• By Dave Wallace

The AAM has welcomed a US appeals court decision backing an injunction against a Minnesota state law on drug pricing, following an earlier favorable district court ruling.

Accord And Sandoz Remain Frustrated As Dutch Xtandi Patent Is Latest To Hold Firm

 
• By Dean Rudge

In a further setback for generics manufacturers, the District Court of The Hague has upheld the validity of a key Xtandi (enzalutamide) patent and its Dutch supplementary protection certificate, rejecting Sandoz and Accord’s challenge based on lack of inventive step.

More from Products

EMA Greenlights Give Eylea And Stelara Biosimilars Momentum Across Europe

 
• By Dean Rudge

The EMA’s Committee for Medicinal Products for Human Use has issued positive opinions for multiple aflibercept and ustekinumab biosimilars, intensifying competition for Eylea and Stelara respectively in Europe. Meanwhile, a Biocon subsidiary also received a nod for a Neulasta biosimilar.

Accord And Sandoz Remain Frustrated As Dutch Xtandi Patent Is Latest To Hold Firm

 
• By Dean Rudge

In a further setback for generics manufacturers, the District Court of The Hague has upheld the validity of a key Xtandi (enzalutamide) patent and its Dutch supplementary protection certificate, rejecting Sandoz and Accord’s challenge based on lack of inventive step.

Medicines For Europe Sets Out Trade Priorities

 
• By Dave Wallace

As Medicines for Europe gears up for a pair of conferences in Brussels next week, the organization has set out trade policy recommendations to strengthen access to medicines and the competitiveness of EU manufacturing, in a seminar with representatives from the European Commission and member states.