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Amgen Fears 'Staggering Loss' After FDA Exclusivity Denial

Law360 (February 23, 2018, 8:06 PM EST) -- Amgen Inc. urged the D.C. Circuit on Friday to quickly block generic versions of its lucrative calcium-control drug Sensipar, saying it faces a “staggering loss” of sales because the U.S. Food and Drug Administration unfairly withheld exclusivity rights.

The drugmaker’s emergency motion came shortly after a D.C. federal judge upheld the FDA’s denial of pediatric exclusivity, which would have kept generics at bay for an extra six months. Amgen, which earned nearly $1.4 billion from U.S. sales of Sensipar last year, wants an injunction pending appeal of...
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Case Information

Case Title

Amgen Inc. v. Alex Azar, II, et al

Case Number



Appellate - DC Circuit

Nature of Suit

2890 Other Statutory Actions

Date Filed

February 21, 2018

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