US FDA’s First Competitive Generic Therapy Approval Comes With A Twist

Apotex’s potassium chloride oral solution is eligible for 180-day exclusivity under new expedited pathway even though Amneal’s generic referencing same product was approved three weeks earlier; Amneal's continued marketing will not be blocked by Apotex’s exclusivity, which is forfeited if it fails to launch within 75 days.

The US FDA’s first approval under the Competitive Generic Therapy pathway came with a twist – it followed the approval just weeks earlier of a first generic, from a different sponsor, to the same reference product.

On Aug. 8, the agency approved Apotex Inc.’s abbreviated new drug application (ANDA) for potassium chloride oral solution, which...

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 Products

Biocon’s Denosumab Biosimilar Approved In The UK As Competition Grows In Europe

 

Denosumab biosimilar ranks are filling up in Europe as approvals flood in. Yet, little is known about the launch dates.

Water Pressure: How European Industry Is Pushing Back On The UWWTD

 
• By 

Concern continues to build in the European generics industry over the threat posed by the EU’s Urban Wastewater Treatment Directive, which was one of the hottest topics of discussion at Medicines for Europe’s legal and annual conferences. And now, the association has intervened in a legal challenge.

Pertuzumab Leader Henlius Receives EU Accreditation For Production Lines

 
• By 

Shanghai Henlius Biotech has received EMA GMP certification for its HLX14 and HLX11 biosimilar production lines, paving the way for faster market entry in the EU and reinforcing its global manufacturing credentials.

Alvotech Boosts Packaging Abilities With Ivers-Lee Acquisition

 
• By 

Alvotech has acquired long-time partner Ivers-Lee to expand its in-house capacity for assembly and packaging ahead of key planned biosimilar launches in 2025, strengthening operational control and supporting global growth.

More from Generics Bulletin

Bakers And Fishermen: How Biosimilars Manufacturers Are Bridging The Skills Gap

 
• By 

At Medicines for Europe’s annual conference in Brussels, executives from Polpharma Biologics and Gedeon Richter spoke about the challenges in finding biosimilars manufacturing staff with the right backgrounds – and how they are looking to other industries to bridge the skills gap.

US Federal Circuit Says No To Teva And Viatris On Remanded Invega Sustenna Appeal

 
• By 

Just days after Viatris was frustrated in its attempts to challenge IP protecting Janssen’s Invega Trinza, the US Federal Circuit has rejected the firm’s and Teva’s bid to invalidate a patent shielding the one-month version of the brand, Invega Sustenna.

Kris Joshi Named Norstella CEO, Prioritizes AI Innovation

 
• By 

Joshi joins the parent company of Citeline, which houses flagship publications Generics Bulletin, Scrip and Pink Sheet, to focus on AI, business harmonization and long-term growth.