"S" Model for Stable & Bioequivalent Generic Drug Development for US Market by ANDA

Product Development Guide for the development of a ANDA product for the US market.The market for generic drug products will increase rapidly in the next decade due to the expiration of patents and exclusivities for major brand name drug products and due to the demand by consumers and governments for less expensive generic alternatives. From a scienti¢c perspective, generic drug product manufacturers must formulate a drug product that will have the same quality, therapeutic e⁄cacy, safety, and performance as its brand name counterpart. Formulation development of an innovator drug product has minimal constraints with respect to choice of excipients, manufacturing methods, and performance characteristics. In contrast, generic drug manufacturers must demonstrate that their formulation is a pharmaceutical equivalent, is bioequivalent, and has the same quality and performance characteristics as the brand name counterpart. Moreover, the generic drug manufacturer will continue to face a variety of legal, regulatory, and patent challenges from the brand name pharmaceutical industry that may delay the entry of the generic drug in the marketplace. The availability of generic drug products will, nevertheless, continue to play an important role, both nationally and internationally, by providing cost-e¡ective medicines to the wider public, which will bring great bene¢ts to consumers as well as to health authorities in nationsaround the world in their quest to make medicines more available and a¡ordable.