AstraZeneca filed a petition and launched a federal lawsuit against the FDA, arguing the agency could not legally approve any generic versions of the drug due to the Orphan Drug Act, which offers seven-year market exclusivity to companies that develop treatments for rare diseases.
Since Crestor was recently approved to treat a rare disease in children, AstraZeneca claimed the drug should be protected from competition, even when used for a different purpose.
AstraZeneca’s request for a temporary restraining order to prevent the FDA from approving the generics was denied by a federal judge on Tuesday. On Wednesday, the agency approved generic versions of Crestor from eight drug companies.
The approvals are expected to drastically decrease the price of the drug by 80 to 90 percent — Crestor costs $260 a month — and eliminate London-based AstraZeneca’s market domination.
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