Optimizing Drug Market Exclusivity in the US and EU Markets

OBJECTIVES: Market exclusivity (ME) allows a manufacturer’s drug to have a monopoly on the market and to be protected from generic drug competition. The ME types granted by the US FDA and EU EMA and the associated strategic evidence requirements are contrasted across the 2 markets. Use cases are presented alongside considerations for special populations to inform strategic approaches to maximizing exclusivity period both for new drug approval and patent extension.

METHODS: We reviewed regulatory guidances from the EMA and FDA around data exclusivity and market protection. We assessed drivers of ME including 1) the benefit afforded by the drug; 2) the mode of action of the drug; 3) special populations such as pediatrics or pregnant women; 4) certain disease indications such as orphan/rare diseases and 5) presence of other patents or timing of patent application. We summarized the pros and cons of the various approach and the exclusivity period for each as well as evidence needed to qualify for each.

RESULTS: There are 7 non-mutually exclusive pathways to ME in the US granting as little as 6 months up to 7 years of exclusivity. In the EU, there are 3 possible types of approaches specifically: market exclusivity, data exclusivity and (extended) market protection granting from 8 years up to 12 years in cases where pediatric IP is involved. Evidence requirements for different exclusivities is presented.

CONCLUSIONS: There are many pathways to gaining exclusivity in the US and the EU markets. A market-specific approach is recommended to maximize ME globally. The ability to enter an expedited approval program will also impact exclusivity and should be considered alongside ME approaches.