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

Lupin Looks To Be First Out Of The Blocks On US Ingrezza, With Zydus Second

US Ingrezza Legal Battles Wrapped Up, With Earlier Teva, Sandoz Deals

 
• By Dean Rudge

ANDA sponsors targeting Neurocrine Biosciences’ Ingrezza (valbenazine) blockbuster are in position to launch – albeit with a 14-year wait that validates the strength of the originator’s IP.

Enter The Fray
• Source: Alamy

Lupin will look to enjoy a seven-month advantage over its rival Indian firm Zydus Lifesciences in the race to debut generic competition to Neurocrine Biosciences’ Ingrezza (valbenazine) treatment for tardive dyskinesia in the US, after both companies in quick succession penned patent-litigation settlements.

Picking up the right to launch its proposed generic beginning 1 March 2038, Lupin faces a 14-year wait to launch...

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

Repurposed Generics For Rare Diseases: Janet Woodcock Proposes Shortcut

A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.

Generic Entresto Floods US Market Following MSN Patent Victory

 
• By Dean Rudge

As many as ten generic versions of Novartis’ blockbuster heart failure drug Entresto (sacubitril/valsartan) have begun entering the US market following recent key legal victories by MSN Laboratories.

Sandoz Streamlines More Trials As First-Half Biosimilars Sales Hit $1.5bn

 
• By Dave Wallace

Sandoz has revealed plans to streamline more biosimilar trials amid evolving regulatory moves towards minimizing the need for comparative efficacy studies. The disclosure was just one of many pipeline and portfolio updates provided as the firm delivered positive first-half results.

UK Decision Opens Up Competition On Forxiga

 
• By Dave Wallace

Generic dapagliflozin rivals to AstraZeneca’s Forxiga are now free to hit the UK market after the country’s Supreme Court lifted the final barrier preventing launch, allowing off-patent firms access to a market worth hundreds of millions of pounds annually.

More from Products

Sandoz Streamlines More Trials As First-Half Biosimilars Sales Hit $1.5bn

 
• By Dave Wallace

Sandoz has revealed plans to streamline more biosimilar trials amid evolving regulatory moves towards minimizing the need for comparative efficacy studies. The disclosure was just one of many pipeline and portfolio updates provided as the firm delivered positive first-half results.

Amgen Stands Firm On IV Checkpoint Inhibitor Biosimilars

 
• By Dean Rudge

Amgen continues to advance its intravenous biosimilar programs for key immuno-oncology agents, including its ABP 234 biosimilar to Keytruda and ABP 206 biosimilar to Opdivo, despite growing interest in subcutaneous formulations enabled by hyaluronidase technology.

‘Concrete Solutions, Not Big Words’ – Samsung Bioepis Suggests European Improvements For Biosimilars

 
• By Dave Wallace

While biosimilars have seen success in Europe, there are still plenty of areas in which policy improvements could solve problems for the market, according to a new Samsung Bioepis white paper. Adam Levysohn, the firm’s local head of commercial strategy, talks about the proposals.