Orphan Drug Designation (ODD)

ODD

Regulatory

Special status granted to drugs developed for rare diseases (affecting <200,000 people in US). Provides incentives including 7-year market exclusivity, tax credits, and reduced filing fees.

Exemplos

Imatinib for CML (initially orphan)
Nusinersen for SMA
Over 5,000 designated, ~800 approved

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Special status granted to drugs developed for rare diseases (affecting <200,000 people in US). Provides incentives including 7-year market exclusivity, tax credits, and reduced filing fees.