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Is it possible to acquire Orphan Drug status?

Before applying for Orphan Drug status we check whether prevalence and incidence of the indications concerned are sufficiently low for a qualification as rare disease.

Even if your indications can't be defined as rare disease because of the prevalence, sub groups of patients could exist (such as patients can't be treated any more) whose prevalence is sufficient for orphan drug regulations.

Thus the first condition for the indication is fulfilled. Contemporaneously we check whether further drugs for a treatment of the indication concerned are available or whether a third party already applied for Orphan Drug status for your pharmaceutical.