Journal of Biology and Today's World

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Reformulation-Focused Life Cycle Management of the FDA-Approved Drugs


Author(s): Kalyana C Venneti, Rohit S Nalavade, Sidharth Shankar Jha, Subramanian Akshay, Tulika Jaokar, Nandu Gattu and Sanjeev Kumar Shangary*

Drug Life Cycle Management (LCM) includes a variety of strategies that are implemented by biotech and pharmaceutical companies to uncover the hidden value of the drug and maximize their sales and extend their commercial lives. Drug reformulation is one of the most widely used line extension strategies, which expands the therapeutic utility of drugs in different ways and provides market exclusivity. Reformulation allows pharmaceutical companies to address specific marketing needs, helps in strengthening a brand, repositioning a drug in an entirely new target population or even new therapeutic area or effectively treat patients with a specific clinical need. The motivation for a company to reformulate its brand varies according to when the reformulation is implemented during the life cycle of the drug. In this review, we present and discuss the life cycle of two new molecular entities approved by the US Food and Drug Administration during the 2001-2010 decade, aripiprazole (Trade name, Abilify) and lacosamide (Trade name, Vimpat), highlighting the reformulation strategies adopted.

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