Abstract
During recent years, expiry of blockbuster patents, short drug lifecycles, rising development costs, heightened health authority scrutiny, dispersing markets, increased competition and need for latest technologies have put the pharmaceutical industry under mounting pressure. Thus, product lifecycle management is a prerequisite for maximizing a product’s lifetime value, improving a company’s product development processes, using product-related information to make better business decisions, and delivering greater value to customers. In order to achieve these goals and develop regulatory strategies for product lifecycle management, the pharmaceutical company should establish an effective lifecycle management team. Incorporating patent lifecycle management in product lifecycle management greatly benefits brand companies as well as specialty pharma, drug delivery, biotech and generic companies. A pharmaceutical product’s life can be described in five distinct phases: development phase, approval phase, introduction phase, commercialization and quality management phase and decline phase. Each phase poses different challenges and provides different opportunities to be considered for fabrication of the product lifecycle management strategies. At the same time, the approach for product lifecycle management varies from country to country. A comparison of various exclusivities and time taken to review a new drug application/submission/market authorization in countries namely United States, European Union, Canada and India suggests that United States is most encouraging to employ various product lifecycle management strategies, European Union is equally good if national policies are ignored, Canada is difficult to comprehend due to stringent laws and limited exclusivity and India is among the least preferred ones, although it is an excellent outsourcing service provider for contract manufacturing and research.
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