Zydus Becomes A Part Of History As It Loses On US Canagliflozin Patents

Three US Patents Not Invalid, New Jersey Court Rules

ANDA sponsor Zydus Cadila has failed to convince a US district court that three patents shielding the Invokana/Invokamet brands were invalid, as it became a little part of history in one of the major trials to be held amid the coronavirus pandemic.

Gavel
Wolfson’s opinion is currently under seal • Source: Shutterstock

Zydus Cadila is facing at least a six-year wait to introduce its proposed generic version of Janssen/Mitsubishi’s former blockbuster Invokana (canagliflozin) and Invokamet (canagliflozin/metformin) tablets, with a US district court upholding as valid three US patents shielding the branded treatments for diabetes.

The order handed down by district court judge Freda Wolfson was the culmination of “the first virtual Hatch-Waxman litigation to be tried remotely from start to finish in the US District Court for the District of New Jersey, and one

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

Gedeon Richter: General Medicines Unit Deserves ‘More Attention And Credit’

 
• By 

Gedeon Richter’s CEO has urged analysts and the firm itself to give more attention to its “unfairly neglected” General Medicines division – which includes both generics and licensed-in innovative products – during the Hungarian firm’s first-quarter earnings call.

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

Biocon Eyes Fundraising Round Amid Discussions On Merger With Biosimilars Branch

 

As financial volatility continues in the industry, Biocon’s board is considering merging its two off-patent drug businesses.

Micro Labs Agrees To 15-Year Freeze On US Bempedoic Acid Rival

 
• By 

Eight more ANDA filers remain in play challenging patents shielding Esperion’s Nexletol (bempedoic acid) after Micro Labs deal out litigation via a settlement agreement.

More from Products

Biocon Biologics Plans To Slow Down After Five Planned Near-Term Biosimilar Launches

 

With a lineup of five high-value biosimilars in the wings, Biocon Biologics may be more selective going forward and plans to take a one product per year approach.

Biocon Eyes Fundraising Round Amid Discussions On Merger With Biosimilars Branch

 

As financial volatility continues in the industry, Biocon’s board is considering merging its two off-patent drug businesses.

Micro Labs Agrees To 15-Year Freeze On US Bempedoic Acid Rival

 
• By 

Eight more ANDA filers remain in play challenging patents shielding Esperion’s Nexletol (bempedoic acid) after Micro Labs deal out litigation via a settlement agreement.