MED2005's current patent protection runs until August 2028 in the USA and August 2025 in Europe. In addition EU rules grant a 10 year protection. Futura would benefit from a period of 8 years’ exclusivity during which data generated by Futura cannot be used for an MAA to support their application. In addition no generic of the product may be marketed for 10 years after the first approval.
In August 2018 Futura filed a Patent Co-operation Treaty patent application which, if successful, could extend patent protection in many countries to 2038. The PCT filing will be moving into the National filing phase in Q1 2020 in line with standard processes. This phase sets out specific, nominated countries under the Patent Co-operation Treaty which, if successful, will provide patent coverage until 2037.
Current US & EU regulations for generic topical pharmaceutical products provide further protection from competitive products as they typically require a clinical trial programme to show equivalence unlike generic oral drugs which typically only require to show bioequivalence.