Supergeneric drug development provides a low-risk alternative for traditional new chemical entity focused business model in pharma industry. With superior characteristcs in comparison to the original brand product, supergeneric drug products can generate significant cash-flow in much shorter time and with less investments.
The idea is to identify active substances that are already in the market and whose patent and regulatory protection has been recently expired or will expiry within the next few years. The molecule is combined with the DelSiTech's drug delivery technology to produce “supergenerics” with superior characteristics over the original brand product. These supergeneric products are protected by the IPR on the silica technology, preventing any competition with the same technology basis. Additional patent protection is sought by filing new patents on the product when possible. The Company has set strict business criteria for selection of in-house product candidates. In addition to favorable patent situation, the sales of the originator product should be > EUR 1 billion per year to ensure the market potential of a controlled release competitor product.Furthermore, the silica-based controlled release product should provide significant medical or compliance advantages over the original product.
Because the supergeneric product is based on existing active substance with an approved regulatory file and extensive safety and efficacy data of the marketed brand product, the development program is limited both in time and costs, consisting of a fraction of development activities needed for new chemical entities.