What Is An Orphan Indication? Orphan Drug Definition An orphan drug is defined in the 1984 amendments of the U.S. Orphan Drug Act (ODA) as a drug intended to treat a condition affecting fewer than 200,000 persons in the United States, or which will not be profitable within 7 years following approval by the FDA.
How Long Does Orphan Drug Status Last? Orphan Drug Designation Awardees are Granted the Following Benefits from the FDA: Tax credits of 50% off the clinical drug testing cost awarded upon approval. Eligibility for market exclusivity for 7 years post approval. Does orphan drug status expire? Orphan Drugs receive a 7-year period of exclusivity from
What Are The Benefits Of Orphan Drug Designation? Orphan Drug Designation Awardees are Granted the Following Benefits from the FDA: Tax credits of 50% off the clinical drug testing cost awarded upon approval. Eligibility for market exclusivity for 7 years post approval. How much is an orphan drug designation worth? A Rise in Orphan Drug