Dynamics of eu market exclusivity: the impact of orphan designation on generic or biosimilar entry

Orphan designation (OD) status was introduced to encourage development of therapies for rare disease. Products that fulfil the OD criteria benefit from a 10-12 year market exclusivity period from market authorisation (MA), which can extend protection from generic competition beyond patent expiry. In this study we explore the impact of OD market exclusivity on the likelihood of generic and biosimilar entry. Factors which may influence the attractiveness of generic entry are also analysed.