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Sensipar Generics: US Court Victory, FDA Approval Position Piramal For Launch

 
• By Sue Sutter

Just days after Piramal was one of three generic drug sponsors found not to have infringed a Sensipar formulation patent, FDA approved company’s ANDA, threatening Amgen’s de facto exclusivity on the blockbuster calcium-sensing receptor agonist.

Life Cycle - Text on Conceptual Gauge with Red Needle. 3D.

Launch of the first US generic of Amgen Inc.’s hyperparathyroidism treatment Sensipar (cinacalcet) moved two steps closer to reality with a federal judge’s patent noninfringement ruling for Piramal Healthcare UK Ltd., followed just days later by FDA approval of the company’s abbreviated new drug application (ANDA).

The two events position Piramal as the only cincalcet ANDA sponsor with full approval and a court ruling of noninfringement...

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More from Biosimilars & Generics

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No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

 
• By Sue Sutter

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