Venugopal.A*, Vijayaraj.S, Kalyana Chakravarthi.G, Saritha.M, Shakeerbasha.S
Department of Pharmaceutical Analysis, Sree Vidyanikethan College of Pharmacy, Sree Sainath Nagar, A. Rangampet, Tirupathi–517102, Chitoor (DT), Andhra Pradesh, India.
A B S T R A C T
Lifecycle management refers to extend the market exclusivity period. The exclusivity period is increasing the marketing period by extending the patent life. Patenting is common type of protection in the life cycle management of prodrugs. In the worldwide market 10% of the drugs are categorized as prodrugs, hence it indicates that prodrugs have a potential market. Hence major pharmaceutical industries try to protect the chemical entity by taking patent to the already existing drug molecule by minor changes in the dosing, by using fixed dose combinations and by renaming of a marketed product. The regulatory bodies provide five years marketing exclusivity for a new chemical entity from the date of drug approval, orphan drugs attain an exclusivity period of seven years, new clinical study and pediatric exclusivities attain an exclusivity periods of three years and six months respectively from the date of approval. Patent extension may increase the marketing period of a product, and in some cases the manufacturer may reduce the price of the drug which is beneficial to the patient. Hence the present review elaborates effective life cycle management of drugs.
Keywords: Prodrugs, Lifecycle management, Chemical entity, Patent extension.