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

18-5046

September 28, 2018
Sensipar Exclusivity Expires, Ending Amgen's DC Circ. Fight

Amgen Inc. and the U.S. Food and Drug Administration have asked the D.C. Circuit to end their case debating whether the drugmaker should get extended exclusivity for its blockbuster calcium-control drug Sensipar, as that exclusivity period has already lapsed.
May 17, 2018
Exclusivity 'Didn't Require Success,' Amgen Tells DC Circ.

Amgen told a D.C. Circuit panel Thursday that it's entitled to extra exclusivity protection for its lucrative calcium-control drug Sensipar because it fulfilled the U.S. Food and Drug Administration's request to study the drug's possible uses in children, only to have the FDA reject the research based on artificially high standards.
March 07, 2018
Amgen Says FDA Flouted Own Rules In Calcium Drug Row

Amgen told the D.C. Circuit on Tuesday that the U.S. Food and Drug Administration flouted its statutory mandates by denying the drug giant pediatric exclusivity for its lucrative calcium-control drug Sensipar, urging the reversal of a district court ruling that upheld the agency's denial.
February 23, 2018
Amgen Fears 'Staggering Loss' After FDA Exclusivity Denial

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.

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