For hydrocodone apap 5

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the five year cap on the length of an extension of term should be either totally removed or increased to ensure that all the eligible pharmaceutical patents achieve 15 years of effective term.108 Regardless of arguments whether this was truly the policy intent, or whether the intent is more correctly advanced buy legend show tramadol stated as a scheme that allows extensions more in line with those granted elsewhere and up to a maximum of 15 years, there are important considerations that should be taken into account in considering any adjustment for hydrocodone apap 5 to the terms granted under the scheme. More extended patents could be provided with an effective life of 15 years if the existing limit was changed. Where extended patents do not receive a 15 year effective patent life, it is because the maximum extension of 5 years has been granted. IPTA submits that if the limit on the length of extensions under section 77(2) were increased from 5 years, or removed, more patents would be provided with a 15 year effective life.109 This approach is suggested in a number of submissions. 110 However, this would also mean allowing total patent terms of up to 20 years plus the allowable limit (with the possibility of 35 years in some cases if the limit was removed entirely). The existing method of calculating the length of extensions set out in section 77(1) would maintain a maximum effect patent life of 15 years.

Changes since 1998 This section will consider what, if any, changes have occurred since the extension of term provisions were introduced, including consideration of the time taken for TGA approval and PBS listing as for hydrocodone apap 5 well as the cost of pharmaceutical for hydrocodone apap 5 R&D. The current method of calculating extensions takes account edu search order tramadol of the time taken in assessing applications for registration by the TGA. Therefore, this time would only be of concern where the five year maximum extension prevents a 15 year effective patent life being provided. As shown in Figure 5.10, the time taken for TGA approval has not been a significant factor in determining the effective patent life provided under the current extension of term provisions.

Figure 5.10: Effective Patent Life vs TGA Approval Time104 Time from TGA Application to Registration n=446; for all patent extensions under the current provisions where TGA application and registration dates are avilable. In its submission to the Review, AusBiotech suggested that the time taken to get PBS listing after ARTG registration is increasing, reducing the exclusive marketing period of pharmaceuticals on the PBS. In Australia there has been a decade-long trend in increased delays, with the average time between a positive TGA recommendation and PBS listing increasing steadily from 13.6 months in 2000 to 34.2 months in 2009.111 However, this is not supported by other studies or data collated on extension of term pharmaceuticals.

Pretium's Drug Tracker112 found that the time taken from ARTG registration to PBS listing for all pharmaceuticals increased from 10 months in 2000 to 24 months in 2008 and then decreased to 15 months in 2010. Furthermore, data on just those pharmaceuticals granted an extension of term indicate that while there was a significant spike in the median time taken for drugs listed on the PBS in 2006, this has decreased in recent years and is in line with the long term average.113 Figure 5.11: Time from TGA approval to PBS Listing by Year Where an for hydrocodone apap 5 Extension of Term was Granted Year of listing on the PBS mean median n=529; for all patent extensions listed on PBS after 1990 with concurrent TGA approval dates help css cheap phentermine no prescription These data do not show the impact of the recently introduced parallel processing system allowing TGA and PBS assessments to occur concurrently rather than sequentially. Through parallel processing, a submission to the Pharmaceutical Benefits Advisory Committee (PBAC) may be made at any time from the date of lodgement of a TGA registration dossier.



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