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eight companies provided a total of 13 examples of medicines which they chose not to sell in Australia or whose sale was delayed or otherwise affected in Australia over the last 10 years due to what they perceived as an insufficient period of data exclusivity.331 Medicines Australia has provided the Panel with three examples of products (the remainder were said to be confidential) and suggests these demonstrate delayed or otherwise affected entrance into the Australian market due to a perception of an insufficient period of data protection. The key patent and regulatory approval details identified by IP Australia for each of these buy tramadol canada examples are discussed generally in the buy tramadol canada following box. Medicines Australia also hydrocodone poppycock identifies four other pharmaceuticals undergoing late-stage development which could be delayed on the basis of insufficient data protection in Australia. Examples suggested by Medicines Australia as demonstrating insufficient data protection Drug A Drug A was approved for marketing in Australia in 2007, around 2.5 years after approval in the United States. The first patent for Drug A was filed in 1987 and expired in 2012 after obtaining an extension of term resulting in an effective patent life of 5 years and 9 months. A second patent relating to the formulation of the drug was filed in 1995, granted in 1998 and will expire in 2020 after obtaining an extension of term resulting in an effective patent life of 13 years and 4 months. If there were no additional patents after the first patent, there might be evidence that the 5 years and 9 months effective patent life for the first patent would have been insufficient time to recoup the costs of providing these phentermine star viagra xanax products to buy tramadol canada Australia and that longer data protection would have created greater incentive. However, the presence of other patents appears to provide a considerable length of protection for the drug in Australia.
Drug B Drug B was approved for marketing in Australia in 2005, nearly 3 years after approval in the United buy tramadol canada States. The first Australian patent for Drug B expired in 2004 while a second patent relating the composition of the drug was filed in 1999, granted in 2003 and will buy tramadol canada expire in 2020 after it received a 6 month extension of term based on the 2005 ARTG registration. Had Drug B been approved in Australia at the same time as in the United States, the first patent would have provided an effective patent life of 7 years.
Also in this scenario, the second patent would have provided an effective patent life of around 17 years, although it was not granted until 2003, which may have been a factor in how long does hydrocodone remain in system the application with the TGA not being made until 2004. It is unclear how only having a 5 year data protection period contributed to the delay in applying for regulatory approval and entering the market in Australia because there was a follow-on patent that provided a longer effective patent life. Drug C Drug C is not currently approved for marketing in Australia. The first Australian patent for Drug C expired in 2007. Patents pertaining to a method of use and a composition of Drug A have also been granted and clonazepam lexapro will expire in 2020 and 2025. Other patents relating to use in combination with other substance and methods of manufacture have also been granted.
Drug C was approved for use in limited circumstances by the European Medicines Agency in 2007 and has an orphan drug designation, meaning it is used to treat a rare condition.
An application for approval by the US Food and Drug Administration was withdrawn following requests for more clinical trials.
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