Effects of new formulation strategy on life cycle management in the US pharmaceutical industry

Abstract

This research discusses the role of new formulation strategies on life cycle management in the US pharmaceutical industry and evaluates its effect on the market life of existing drug products. We constructed a method to quantitatively measure the life cycle extension period of new formulation pharmaceuticals, including censored cases, wherein the generic drug has not yet been approved and the innovator drug is surviving in the market. We employed 180 new formulation approvals for which Abbreviated New Drug Application approvals were granted for new molecular entities. We undertook a comprehensive and quantitative analysis of how long these new formulation pharmaceuticals are able to prevent the entry of generic pharmaceuticals into the US market after the end of the regulatory exclusivity period. The results showed that among the oral formulations, dosage forms that require advanced manufacturing technology, such as “Extended/Delayed Release,” have significantly extended the life cycle extension period over the past 20 years. In addition, the acquisition of formulation-related patents protecting products was observed to extend the life cycle extension period significantly. These research outcomes can help business strategists in the pharmaceutical industry to take advantage of already marketed new molecular entities as part of the life cycle management strategy and can help generic drug companies adapt to the strategies of innovator drug companies.