Eagle Hit With Double Whammy On Vasopressin ANDA Product

ANDA Filer Eagle Has Previously Suggested Launching ‘At Risk’

Eagle Pharmaceuticals was gearing up for patent-litigation proceedings with Endo over Vasostrict on 1 February but has quickly seen the landscape shift.

Setback
Eagle has quickly seen a trial date shift from January to July, in addition to the CRL. • Source: Shutterstock

Eagle Pharmaceuticals has received a complete response letter from the US Food and Drug Administration declining final approval for the firm’s proposed generic version of Endo’s Vasostrict (vasopressin), at the same time as a key patent infringement trial was once again pushed back, this time by more than five months.

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 Generics

Lupin Touts FDA Approval For Generic Tolvaptan With 180-Day Exclusivity

 

After receiving a favorable court ruling last year, Lupin has secured its first-place spot for generic tolvaptan tablets in the US.

BGMA Becomes Medicines UK

 
• By 

The UK generics and biosimilars industry will now be represented by Medicines UK, the new name for the former British Generic Manufacturers Association.

UK Forxiga SPCs Wiped Out As Trio Succeed With Plausibility Attack

 
• By 

Generic competition to AstraZeneca’s blockbuster SGLT2 inhibitor Forxiga (dapagliflozin) treatment for diabetes may hit England and Wales earlier than 2028 after a pair of SPCs were invalidated following proceedings initiated by a trio of generics manufacturers.

Iconovo Slims Down As It Focuses On Commercialization

 
• By 

As its need for development resources declines, Iconovo is cutting staff to save money as it moves to the commercialization stage for its portfolio of off-patent inhaled products.

More from Products

J&J Denied Injunction Over Private-Label Ustekinumab In US

 
• By 

Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.

UK Forxiga SPCs Wiped Out As Trio Succeed With Plausibility Attack

 
• By 

Generic competition to AstraZeneca’s blockbuster SGLT2 inhibitor Forxiga (dapagliflozin) treatment for diabetes may hit England and Wales earlier than 2028 after a pair of SPCs were invalidated following proceedings initiated by a trio of generics manufacturers.

What’s Next? Five Things To Look Out For In May

 
• By 

Generics Bulletin previews the most noteworthy and anticipated events for May 2025.