Limiting Market Exclusivity for Rare Disease Drugs
This law changes the rules for granting the 7-year market exclusivity period for drugs treating rare diseases. Instead of covering the entire disease, exclusivity will now apply only to the specific, approved use or indication of the drug. This aims to speed up access to competitive drugs and new therapies for patients suffering from rare conditions.
Key points
Market exclusivity for orphan drugs (for rare diseases) will be limited to the specific, approved use, rather than the entire disease or condition.
This change is intended to increase competition and potentially lower treatment costs by allowing alternative therapies to enter the market sooner.
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