Yes, orphan drugs can be sold. The FDA grants orphan drug status to a company, which gives them exclusive marketing rights for seven years. This status is designed to help companies develop drugs for rare diseases and recoup the costs of research and developmentOrphan drugs can cost between $6,000 and $500,000 per year, with an average of $32,000 per year. More than a third of drugs with orphan indications cost more than $100,000 annually. However, high cost therapies are generally prescribed for a small portion of patients. For example, most drugs for diseases with 10,000 or more patients are priced between $25,000 and $150,000 per year, whereas most drugs for indications with less than 10,000 patients in the US are priced at or above $200,000 per year.Manufacturers explain the high prices as resulting from the growing costs of research and development. R&D expenses for orphan drugs must be recouped from a small number of patients, resulting in high drug treatment costs per patient.The Orphan Drug Act gives drug companies incentives to develop treatments for rare diseases, including a 25% tax credit on qualified clinical trials. Other incentives include a rebate on application fees and a seven-year window of drug exclusivity
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