Perrigo Draws On OTC Strength For Private Label Nexium 24HR Launch

Perrigo plans late September launch of a store brand OTC of Nexium 24HR after FDA’s ANDA approval and settlement of patent litigation with AstraZeneca. But it faces competition from Aurobindo's generic OTC esomeprazole 20 mg delayed-release capsules.

Perrigo Co. PLC faces a somewhat unfamiliar challenge of having competition from the start in its upcoming launch of an OTC private label version of Nexium24HR. But with its experience and reputation in private label products, it should seize the top spot among generics of the OTC treatment frequent heartburn and drive its consumer business sales.

Perrigo announced Aug. 21 that FDA granted final approval for its abbreviated new drug application for a store brand OTC...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Legal & IP

More from Pink Sheet

‘Prices Can Remain Contaminated Indefinitely’: Advanz Brushed Aside On UK Liothyronine Appeal

 
• By 

England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.

New EU Filings

 

Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.