2. >>Legal & IP

Generic Or Innovator? Sandoz Sues CMS Over Potential Change In Rebate Classification

CMS Emails ‘Muddy The Waters,’ Sandoz Claims; Drugs Are ‘Quintessential Generics’

 
• By Dean Rudge

Sandoz has fired a defensive shot in a US court against the potential that it may have to fork up higher rebates for two of its drugs via the Centers for Medicare & Medicaid Services’ Medicaid drug rebate program – six years after the suggestion was first made.

rebate - cube with letters, sign with wooden cubes
• Source: Shutterstock

Sandoz has filed what it terms a “defensive” lawsuit against the US Centers for Medicare & Medicaid Services, stemming from the potential that two of its drugs could be classified as ‘innovator’ drugs under the Medicaid drug rebate program statute and therefore subject to higher rebates.

Six years ago, the CMS advised Sandoz – but importantly, according to Sandoz, did not render a final a decision...

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