OBJECTIVES: Pharmaceutical manufacturers routinely face the challenge of eroding patents of their major brands. Companies have to prepare well in advance for the loss of exclusivity (LoE) and this is always under the scrutiny of payers and shareholders alike. Entry of generics leads to substantial revenue losses and managing it is in some instances even more challenging than launching a branded product. This research is aimed at elucidating the policies that pharmaceutical companies need to consider as they prepare for LoE of their branded products. This paper also deals with the strategic aspects that lead to maintaining a successful product post LoE.  METHODS: The research was conducted through in-depth secondary research and interviews with key stakeholders in 8 countries including the UK, Japan, France, Germany, Italy, Austria, Sweden and Belgium RESULTS: Analysis indicates that the markets react differently when a product loses patent and this is dependent on the policies of generic substitution, clinical training of the physicians in the country, prescription habits and policies, awareness of patients and more importantly socio economic conditions of the country. These factors lead to differences in the potential price and access of the branded drug post LoE in the different markets making it a challenging process. CONCLUSIONS: The research identifies the stage at which a pharmaceutical company should start to prepare for the LoE, the typical projects that need to be conducted and also the opportunities the companies have with the product. Market specific strategies were assessed that included policy implications of generic substitution, the powers of physicians and retail pharmacists in prescribing, substituting and dispensing respectively and how policies play a role in influencing the pricing and reimbursement of the product post LoE and its generic competitors.