An at-risk launch occurs when which event takes place?

• A. The brand drug loses patent protection automatically
• B. A generic manufacturer challenges the validity of the brand drug patent
• C. The FDA withdraws approval
• D. A biosimilar is approved before the brand's patent expires

Answer: (B)

An at-risk launch happens when a generic manufacturer challenges the brand drug patent. Under Hatch-Waxman, the generic filing includes a Paragraph IV certification, asserting that the patent is invalid, not infringed, or unenforceable. If the court ultimately sides with the generic, it can enter the market before the brand patent expires. If the patent is upheld, the generic faces potential infringement damages. That blend of potential early entry and patent litigation is what defines an at-risk launch.

The other scenarios don’t describe this legal maneuver. Losing patent protection automatically isn’t something a company “launches” into; patent expiry is a fixed term, not an event triggered by the generic. FDA withdrawal of approval is a regulatory action, not a patent challenge that enables earlier entry. A biosimilar being approved before a brand’s patent expires involves a different pathway and set of exclusivities, not the generic Paragraph IV challenge that drives at-risk launches.