Nov 17, 2025 · According to the Food and Drug Administration (FDA), an orphan drug is generally entitled to a seven-year market exclusivity period following its marketing approval.

Mar 5, 2024 · During the exclusivity period, the FDA may not approve another application for a competing product. For example, if a drug manufacturer receives FDA approval to market a …

Market exclusivity is available to developers of orphan-designated drugs to provide protection from competition after approval as a way of incentivizing development of drugs for rare …

One of the key aspects of the Orphan Drug Act of 1983 is a seven-year market exclusivity granted to drugs that treat rare diseases. Since the passage of the Orphan Drug Act, a total of 503 …

12 months stay of generic or biosimilar approval if litigation is initiated. 9 months stay of generic approval if litigation is initiated.

PhD, RAC oval as a way of incentivizing development of drugs for rare diseases. In the US, developers get seven years exclusivity from the same drug being approved for the same …

‘(...) medicinal products for human use which have been authorised in accordance with the provisions of this Regulation shall benefit from an eight-year period of data protection and a …

Aug 16, 2025 · One of its key incentives is the grant of **7 years of market exclusivity** for approved orphan-designated drugs. This exclusivity prevents the FDA from approving any …

Market exclusivity (ME) allows a drug to have a monopoly on the market and to be protected from generic drug competition There are 5 non-mutually exclusive pathways to ME in the US …

Jul 8, 2022 · Particularly, the 7-year market exclusivity (termed Orphan Exclusivity) is determined by the Office of Orphan Product Development (OOPD) upon marketing approval of the drug.