Question

What are orphan drugs. how are the defined in the US?

Answer 1

Orphan drugs are a pharmaceutical agent that has been developed to treat a rare medical condition, called Orphan disease. In the US and EU it is easier to gain marketing approval for an orphan drug, and there may be other financial incentives, such as extended exclusivity, all intended to encourage the development of drugs which might otherwise lack a sufficient profit motive.The Orphan Drug Act (ODA) of January 1983, passed in the United States, with lobbying from the National Organization for Rare Disorders and many other organizations, is meant to encourage pharmaceutical companies to develop drugs for diseases that have a small market.