Apotex Pays Out Over US Price-Fixing Claims

Deal Over Pravastatin Includes $24.1m Fine And Deferred Prosecution Agreement

Apotex has agreed to pay a $24.1m fine and enter into a deferred prosecution agreement to resolve US price-fixing claims over the cholesterol-lowering drug pravastatin.

Apotex
Apotex has settled US price-fixing allegations over pravastatin • Source: Shutterstock

Apotex has agreed to pay a $24.1m fine and has entered into a deferred prosecution agreement with the US Department of Justice to resolve price-fixing claims over the pravastatin cholesterol-lowering treatment, in the latest development arising out of ongoing generic pricing investigations in the US.

“Apotex Corp. has reached a resolution with the DoJ’s antitrust division concerning the department’s years-long antitrust investigation into the US...

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

More from Legal & IP

Lupin Concedes To Wakix IP With 2030 Launch Date Agreement

 
• By 

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

 

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 

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

 

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.

More from Generics Bulletin

Regulatory Recap: EU Pharma Package Progresses Forward With Extended Data Protection

 

Generics Bulletin reviews global regulatory developments across the world.

Regeneron Monitoring Eylea Biosimilar Closely Following Innovative Setbacks

 
• By 

Regeneron says it is closely watching Amgen’s Pavblu 2mg aflibercept biosimilar, which is gaining traction via financial incentives to physicians as “the only differentiator” to its Eylea reference brand. Meanwhile, Regeneron is aiming to boost Eylea HD uptake amid regulatory setbacks.

Generic Drug Office’s Policy Staff Returning To US FDA

 

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.