FDA patent math could wreck your wallet

Key points

• The FDA is officially calculating the patent extension period for the drug BIZENGRI.
• This decision will determine how long the manufacturer has exclusive rights to sell the drug before generic versions can be made.
• The company that makes BIZENGRI benefits from a longer patent, while patients seeking lower prices benefit from a shorter one.
• The FDA holds the authority to determine the regulatory review period, a key part of the extension calculation.
• This process is a standard regulatory interaction, not an indication of wrongdoing.

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