Orphan Drug Designation

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Orphan Drug Designation is a status given to certain drugs targeting rare disease or conditions that affect fewer than 200,000 people for the United States and for Europe, fewer than 5 in 10,000 people.

Product Candidate Country Indication
Ampligen® USA CFS/ME
Ampligen® USA HIV
Ampligen® USA Metastatic Melanoma
Ampligen® USA Renal Cell Carcinoma
Ampligen® USA Pancreatic Adenocarcinoma
Ampligen® European Union Pancreatic Adenocarcinoma
Ampligen® USA Ebola Virus Disease
Ampligen® European Union Ebola Virus Disease
Alferon N Injection® European Union MERS


Orphan Drug Designation Provides a Number of Incentives Including:

United States


7-year market exclusivity upon
potential approval

25% tax credit on clinical testing expenses

Waiver of the Prescription Drug User Fee Act (PDUFA) application fee


10 years of market exclusivity

Study protocol development assistance

Fee reductions for regulatory filings