Paragraph IV
A generic manufacturer's certification that a brand drug's patents are invalid or not infringed.
Definition
A Paragraph IV certification is a generic manufacturer's declaration (in their ANDA filing) that the brand drug's Orange Book patents are invalid, unenforceable, or not infringed by the generic. It triggers a 45-day window for the brand owner to sue, which automatically stays generic approval for up to 30 months while litigation proceeds.
See also
- Orange Book — The FDA-maintained list of approved drug products with patent and exclusivity information.
- ANDA — The FDA pathway for approving a generic copy of a previously-approved small-molecule drug.
- Patent cliff — The steep drop in revenue when a drug's patents expire and generic competition launches.