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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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Lupin Concedes To Wakix IP With 2030 Launch Date Agreement

 
• By Dean Rudge

Ahead of a bench trial beginning in February 2026, Lupin has become the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster by the end of the decade.

Patent Settlements Are ‘Critically Necessary’ As AAM Calculates $423bn Savings Since 2013

 
• By Urtė Fultinavičiūtė

The US healthcare system saved billions by allowing early market entry for generic and biosimilar medicines through patent settlements. However, long-winded litigations with an expensive price tag and the Senate’s reintroduced pay-for-delay bill are set to make the situation even more dire.

AstraZeneca Agrees Last-Minute $50m Settlement In Seroquel XR Delay Case

 
• By Dean Rudge

A class action suit alleging AstraZeneca delayed generic competition for Seroquel XR by making illegal agreements that stifled market entry for generic quetiapine competitors has been dismissed after the originator agreed to settle for tens of millions of dollars.

Trump’s FTC Continues The Mission Of Eliminating Orange Book’s Improper Patent Listings

 
• By Urtė Fultinavičiūtė

In a somewhat surprising move, president Donald Trump’s Federal Trade Commission carries the torch in a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon told Generics Bulletin what it means for the generic drug industry.

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US ‘Red Tape’ Bill Again Targets Biosimilar Interchangeability – Will It Succeed This Time?

 
• By Dave Wallace

After multiple past attempts, US legislators have once again proposed a bill that would make all biosimilars immediately interchangeable upon approval. Could a fresh political context help it to succeed this time?

AstraZeneca Agrees Last-Minute $50m Settlement In Seroquel XR Delay Case

 
• By Dean Rudge

A class action suit alleging AstraZeneca delayed generic competition for Seroquel XR by making illegal agreements that stifled market entry for generic quetiapine competitors has been dismissed after the originator agreed to settle for tens of millions of dollars.

Trump’s FTC Continues The Mission Of Eliminating Orange Book’s Improper Patent Listings

 
• By Urtė Fultinavičiūtė

In a somewhat surprising move, president Donald Trump’s Federal Trade Commission carries the torch in a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon told Generics Bulletin what it means for the generic drug industry.