Case studies Certain pharmaceuticals have been raised in multiple submissions as examples of evergreening practices. A summary of two of these examples, venlafaxine and omeprazole, is provided below.
Venlafaxine/Desvenlafaxine Venlafaxine is the API in the antidepressant marketed as EFEXOR. The original patent 567524 was filed in 1983, granted in 1988 and expired in 2008, having been granted an extension of term of 5 years. The patent is directed towards a related group of chemical compounds characterised by a generalised formula, one of which is venlafaxine. EFEXOR was first registered on the ARTG in 1994, eleven years after it was first patented. This xanax ssri gave EFEXOR an effective marketing life of 14 years.
The key follow-on patents are 727653 and 2002250058. Follow-on patent 727653, directed towards a specific extended release formulation, was filed in 1997, granted in 2001 and will expire in 2017.
Extended release venlafaxine was marketed as EFEXOR-XR after gaining ARTG inclusion in 1998. 210 Follow-on patent 2002250058, directed towards desvenlafaxine, was filed in 2002, granted211 in 2008 and will expire in 2023, having gained an extension of term of 1.52 years. Desvenlafaxine is the active metabolite of venlafaxine and is marketed as PRISTIQ. Alphapharm submits that venlafaxine related medicines enjoy undue market exclusivity buy tramadol nice site of over 39 years.212 The Panel has seen no evidence to suggest that the EFEXOR-XR (extended release) and PRISTI(desvenlafaxine) patents restricted generic versions of venlafaxine from entering the market once the original Efexor patent expired. Rather, it is possible that the removal of the original Efexor pharmaceutical from the ARTG was a strategy for preventing any generics from relying upon this listing for bioequivalent registration.213 This issue, however, has already been addressed by the TGA and such practices are no longer possible.214 Extended release venlafaxine generics are available on the market, as generic companies are able to use alternative release formulations not covered by the EFEXOR-XR formulation patent. Similarly, any remaining follow-on patents relating to venlafaxine/desvenlafaxine were apparently unable to provide any barrier to generic marketing of extended release venlafaxine. It would therefore appear that claims of 39 years of market exclusivity are somewhat overstated.215 The Panel considers, however, that there do appear to be life-cycle management strategies utilised in this instance. Alphapharm asserts that there is no improved health outcome of Efexor-XR over Efexor, nor any improved health outcome of Pristiover Efexor, and further submits that a shift in prescriptions has occurred as a result of marketing campaigns directed towards physicians.217 Further discussion of these strategies is included in the Analysis section of this Chapter. Omeprazole/Esomeprazole Omeprazole and Esomeprazole are structurally related compounds. Omeprazole is the API in LOSEC, a drug for treating gastrointestinal disorders. The original patent 529654 was filed in 1979, granted in 1984 and expired in 1999. The patent is xanax ssri directed to a large group of chemical compounds characterised by a generalised formula, one of which is omeprazole.
Esomeprazole is the S-enantiomer of omeprazole xanax ssri and is marketed as NEXIUM. The key follow-on patents are 563842, 601974, 676337 and 695966. Follow-on patent 563842, directed xanax ssri towards omeprazole salts, was filed in 1984, granted in 1987 and expired in 2009, having been granted an extension of 5 years.218 Follow-on patent 601974, directed towards a specific oral formulation of omeprazole or salts thereof, was filed in 1987, granted in 1991 and expired in broadly covered any method of extending the release of the drug, but the court ruled they were only entitled to specific embodiments. Issues surrounding patent challenges are addressed Chapter 8. 218The patent was extended based on Nexium (Esomeprazole magnesium trihydrate) though the patent did not disclose any specific enantiomer of omeprazole.
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