1. Generics Bulletin
  2. >>Products
  3. >>Generics

American Regent’s Vasopressin Questioned As Eagle Prepares ANDA Launch

Daiichi Sankyo Affiliate Holds 505(b)(2) NDA Approval For Vasostrict Rival

 
• By Dean Rudge

With Eagle set to launch its long-awaited vasopressin ANDA product on 17 January, the US firm’s management told investors it was unsure what its launch meant for the 505(b)(2) rival product in the hands of American Regent.

Launch Button Finger Press
Eagle is launching its product at risk with an appeal pending • Source: Olivier Le Moal / Alamy Stock Photo

American Regent’s US Food and Drug Administration approved 505(b)(2) hybrid new drug application product referencing Endo International’s Vasostrict (vasopressin) is a puzzle for investors – and it appears to be one for recent ANDA recipient Eagle Pharmaceuticals, as well, as it looks to make good on its award of 180 days of generic market exclusivity.

Endo had “mentioned that one of the parties that they had settled with filed through the 505(b)(2) process, and they’re saying that – conceptually – that should allow them to launch around the same time as you. Is that sort of in line with what you’re thinking

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 Generics

Adalvo And Gedeon Richter Join Forces On Semaglutide

 
• By Dave Wallace

Adalvo and Gedeon Richter have announced a global co-development deal for semaglutide for obesity. Adalvo CEO Anil Okay spoke to Generics Bulletin about the alliance as well as the broader competitive landscape for GLP-1s.

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

 
• By Urtė Fultinavičiūtė

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 Dave Wallace

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 Dean Rudge

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.

More from Products

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

 
• By Urtė Fultinavičiūtė

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

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By Dave Wallace

As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.

Amgen’s Aflibercept Starts Strong As Regeneron Counts Cost Of Eylea Competition

 
• By Dean Rudge

Amgen told investors during its 1 May first-quarter earnings call that its Pavblu biosimilar to Eylea 2mg had flown out of the gates, while Regeneron admitted “some difficult news related to our retinal franchise.”