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.

예시

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

알고 계셨나요?

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.