Orphan Drugs: Market Exclusivity Limited to Specific Approved Uses.
The RARE Act changes market exclusivity rules for drugs treating rare diseases. Instead of protecting a drug for an entire disease, exclusivity will now apply only to a specific, approved use, potentially impacting drug availability and competition for patients.
Key points
Market exclusivity for orphan drugs will be limited to a specific, approved use or indication, not the entire rare disease.
This change could increase competition and access to other drugs for the same rare disease but for different uses.
The new rules apply to all designated drugs, regardless of their approval date, affecting both new and existing medications.
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