A branded medicine is protected from direct copies in two ways: by patents, and by regulatory exclusivities granted when it is approved. Loss of exclusivity happens when both have run out or been successfully challenged.
In the United States, regulatory exclusivities include five years for a new chemical entity, three years for certain new clinical investigations, seven years for an approved orphan indication, an additional six months for qualifying pediatric studies, and twelve years for a new biologic before a biosimilar can be approved. In the European Union, new medicines generally receive eight years of data protection plus two years of market protection, with a possible extra year for a significant new indication.
Patents are often the longer protection, but they can be challenged. In the US, a generic company can file an application certifying that a listed patent is invalid or not infringed, which often leads to litigation and, in many cases, a 30-month stay on approval while the dispute proceeds.
Loss of exclusivity usually brings a steep fall in the brand’s sales as cheaper versions enter. Its timing, for your own products and your competitors’, is one of the most important dates in long-term planning.