Sensipar Generics: US Court Victory, FDA Approval Position Piramal For Launch
Executive Summary
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.
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Piramal’s Sensipar Generic Is Blocked In The US
Piramal halted sales of its generic version of Amgen’s Sensipar following a US court order that also required Amgen to furnish a $39m bond. The Sensipar generic launch landscape continues to be complex with multiple legal challenges, including those from Cipla and Sun at various stages.
Piramal’s Sensipar Generic Blocked In US, For Now
Piramal halted sales of its generic version of Amgen’s Sensipar following a US court order that also required Amgen to furnish a $39m bond. The Sensipar generic launch landscape continues to be complex with multiple legal challenges, including those from Cipla and Sun at various stages.