Infringement Order Blocks Viatris’ US Symbicort Rival Until July 2023

Viatris Believes It Could Lose FDA Approval For Breyna Generic

After a string of victories, Viatris has fallen to AstraZeneca’s US Symbicort intellectual property, pushing back its planned generic launch by half a year.

Mobile Electronic Traffic Sign stating “expect Delays” taken at sunset with traffic blurred driving past the sign and traffic cones

Viatris is facing a potential six-month delay to the planned launch of its Breyna US generic version of AstraZeneca’s Symbicort (budesonide/formoterol fumarate dihydrate) pressurized metered dose inhaler, after falling to the originator in the latest episode of its ongoing legal saga.

A US District Court for the Northern District of West Virginia judge has entered final judgment against Viatris and partner...

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

Hikma Rides Price Gap as Novo’s Ozempic, Wegovy Costs Climb

 
• By 

Hikma is seeing increased US demand for its generic Victoza (liraglutide) after the end of semaglutide compounding lifted prices for Novo Nordisk’s Ozempic and Wegovy. Meanwhile, the company is not for now pursuing semaglutide generics in the US or EU due to patent protection, but is targeting MENA.

Lupin Launches Generic Version Of Lilly’s Discontinued Glucagon In The US

 

Alongside biosimilars, Lupin sees injectable products as one of the key growth drivers in the US, as competition for two of its “material” drugs and proposed tariffs are looming over the firm.

Arizonans To Be Offered Up To 80% Discount On Generic Drugs

 

Arizona’s governor Katie Hobbs pointed to Trump’s One Big Beautiful Bill and other federal failures as she signed an executive order to increase access to medications in her state.

Iron Sucrose Competition Expands With Viatris and Amphastar FDA Approvals

 
• By 

Viatris and Amphastar are expanding their complex generic portfolios with the planned launches of FDA-approved versions of Vifor Pharma/Daiichi Sankyo’s Venofer (iron sucrose). The FDA’s database also show Sandoz holds an approval for generic Venofer, though it has not disclosed launch plans.

More from Products

Iron Sucrose Competition Expands With Viatris and Amphastar FDA Approvals

 
• By 

Viatris and Amphastar are expanding their complex generic portfolios with the planned launches of FDA-approved versions of Vifor Pharma/Daiichi Sankyo’s Venofer (iron sucrose). The FDA’s database also show Sandoz holds an approval for generic Venofer, though it has not disclosed launch plans.

Generic Drugs And AI: Maximum Daily Dose Tool Could Help US FDA Be ‘At The Forefront’

 

The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.

Amgen Welcomes Evolving Biosimilar Guidelines As Competitive Advantage

 
• By 

Amgen sees potential regulatory shifts toward streamlined biosimilar approvals as favorable, citing its strength in developing high-quality products.