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US Launch Of Sensipar Generics May Await Patent Case Even After FDA Approval

 
• By Sue Sutter

Aurobindo remains embroiled in litigation with Amgen on a Sensipar formulation patent, while Cipla settled ahead of  bench trial. Generic firms won approval of cinacalcet generics after two federal courts denied Amgen's emergency request for an injunction in dispute with FDA over pediatric exclusivity.

Gavel

Despite the US FDA's approval of two generic versions of Amgen Inc.'s Sensipar (cinacalcet), competition to the branded calcium-sensing receptor agonist may await the outcome of patent litigation in a Delaware federal court.

FDA approved cinacalcet abbreviated new drug applications (ANDAs) from Aurobindo Pharma Ltd. and Cipla Ltd. on March 8....

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

 
• By Dean Rudge

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

 
• By Urtė Fultinavičiūtė

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

 
• By Urtė Fultinavičiūtė

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 Dean Rudge

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.

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Iron Sucrose Competition Expands With Viatris and Amphastar FDA Approvals

 
• By Dean Rudge

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’

 
• By Michael McCaughan

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 Dean Rudge

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