1. Generics Bulletin
  2. >>Legal & IP

Vanda Sues FDA For ‘Cutting Corners’ On MSN’s Generic Hetlioz Approval

Patient Population For MSN’s Generic Tasimelteon Targeted In New US Suit

 
• By Dean Rudge

Looking to take the FDA to court again, Vanda Pharmaceuticals has sued the agency for the way in which it evaluated and approved MSN Pharmaceuticals’ generic version of its sleep-wake disorder drug Hetlioz.

FDASignBldg21Entrance_1200x675
• Source: Shutterstock

Indian generics manufacturer MSN Pharmaceuticals’ recent US Food and Drug Administration approval for a generic version of Vanda Pharmaceuticals’ Hetlioz (tasimelteon) was “unlawful and poses serious safety risks to public health,” because the agency in approving it disregarded its own “accepted principles of bioequivalence,” according to a lawsuit filed against the FDA by the originator.

Vanda has proven itself a serial litigator as it seeks to defend its intellectual property, having also this year sued...

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 Legal & IP

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.

Shilpa Stumbles On Lenvima Challenge And Faces Wait Until 2036

 
• By Dean Rudge

Generic competition to Eisai’s oral-dose blockbuster cancer therapy Lenvima is set to materialize in the US in 2030 – however, for now, that won’t be from ANDA filer Shilpa Medicare.

More from Generics Bulletin

Xbrane Sets Date For Latest Run At Ranibizumab In US

 
• By Dave Wallace

After a series of setbacks for its Lucentis (ranibizumab) biosimilar filing in the US, Xbrane Biopharma now has a fresh action date from the FDA – although any approval will be contingent on a successful agency reinspection of its manufacturing sites.

Zydus Strikes Landmark $141m Agreement To Break Into Global CDMO Business

 
• By Dean Rudge

Zydus Lifesciences said it would be able to leverage supply chain dynamics and a “favorable geopolitical environment” to expand its reach in the US and globally as it penned a trio of agreements to plant its flag in the global CDMO space.

Dr Reddy’s And Alvotech Team Up On Keytruda Rival

 
• By Dave Wallace

After previously partnering on denosumab, Alvotech and Dr Reddy’s have announced a further alliance to co-develop a biosimilar version of Keytruda (pembrolizumab).