Generic competition in pharmaceutical industry - How long does it take for generic drugs to enter the market after having applied for Market Authorization in Norway?

ABSTRACT Background: Historically in Norway, pharmaceutical prices have been particularly high for originator drugs, which are produced by originator companies that have a monopoly through the patent system. However, once the patent expires, generic drugs are able to enter the market and cause a considerable decline in price. The Norwegian Medicine Agency (NoMA) is responsible for issuing market authorization (MA) and inclusion in the reimbursement scheme, for any new drugs in Norway. NoMA must evaluate the cost-effectiveness analysis of the originator drug provided by the pharmaceutical company. In order to predict cost- effectiveness, it is important to estimate how long the originator drug will stay in the market before generic competition is established. Objectives: Investigate how long it takes for a generic drug to enter the market after applying for MA, and what are the potential reasons for the time span used. Methodology: A combination of qualitative and quantitative study design. Empirically based and a single-case study. There were in-depth interviews conducted with executive officers at NoMA and representatives from generic and originator firms. The quantitative data was collected from the NoMA´s databases, namely Athene and P360. The data was divided into four phases and a statistical description of each phase was created. Furthermore each phase was divided into two periods 2005-08 and 2009-12 for the purpose of running a Man Whitney U test in order to reveal the time differences between the two periods. Results: For quantitative analysis the following was found: (1) For a generic medicine to obtain MA it takes 357 days according to median. (2) A generic drug used 131 days (median) to enter the market after MA approval. (3) Additionally in the second period 2009-12 it took longer time to obtain MA and enter the market compared to the first period of 2005-08. For qualitative analysis the following was discovered: (1) Various obstacles which affect the MA process. (2) Patent obstacles and complications which affect the overall time span. (3) Norway is a relatively small market and therefore less attractive for some generic companies. (4) Production issues and challenges faced by generic firms. (5) In some cases, the substitution list and reimbursement scheme processes can cause delays to the overall time span. (6) Once the original drug patent expires, the original firms can choose to enter the stepped price system and create competition for generic firms, which causes a delay in entering the market