British pharmaceutical giant AstraZeneca has filed a lawsuit against the Food and Drug Administration to block approval of generics for its best-selling cholesterol pill.
The drugmaker argues that its drug Crestor should be entitled to seven years of additional market exclusivity under the Orphan Drug Act. The cholesterol-lowering pill is AstraZeneca's best-selling drug, accounting for $5 billion of its $23 billion in product sales.
Crestor, prescribed 20.3 million times in 2015, is scheduled to lose its patent protection on July 8.
AstraZeneca won market exclusivity for the drug in May 2015 but only to treat a rare genetic disease in children called homozygous familial hypercholesterolemia. This allows the FDA to approve generic versions of the drug for conditions other than the rare HoFH disease.
In a petition to the FDA filed June 21, AstraZeneca argues that it's dangerous and illegal to approve the drug for generics if the appropriate dosage for HoFH can't be approved as well.
AstraZeneca says it will file a temporary restraining order if the agency refuses to hear the case.
