Fixed-Dose Combinations: Innovations and Research

Innovation is a key element that drives the pharmaceutical industry. Pharmaceutical companies strive hard to find answers to the disease through new drugs. Most companies are involved in innovations and the majority of which are incremental. Pharmaceutical incremental innovations may include new indications for the current drugs, new dosage forms, and new doses in a certain formulation with increased bioavailability. A fixed-dose combination (FDC) product, a kind of incremental innovation, is a combination of two or more active pharmaceutical agents in a single dosage form. FDCs provide the advantage of combined and complementary action of combined therapy while reducing the number of pills and prescriptions. However, their real contributions have been muddled by disadvantages and stayed away from primary therapy. The chapter consists of a brief description of the ongoing debate of rational and irrational combinations, the reason behind many pharmaceutical companies veering toward incremental innovations. It gives an overview of the regulatory and patent scenario of FDCs. Statistics related to FDC approvals, approvals given by US Food and Drug Administration, and their description have been dealt with. Overall, fixed-dose combinations are a boon and have benefits to offer to their stakeholders.