API Patent Poses Significant Barrier to Generic Launch Ziprasidone in Europe and Australia

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GenericsWeb, the leader in established pharmaceutical patent analysis and searching, recently published an article based on its proprietary Pipeline Patent Intelligence that analyses opportunities in launching generic versions of generic Ziprasidone equivalents of Pfizer’s blockbuster atypical antipsychotic drug (Geodon® and Zeldox®). Global Geodon®/Zeldox® sales generated US$1.02 billion in 2011.

The article by GenericsWeb highlights the following observations in relation to generic Ziprasidone:

  •     The two most constraining patent families (US8700423W and US14688688A) generally preventing the launch of a generic relate to the API; both claiming the Ziprasidone molecule.
  •     Patents in US8700423W have been extended by supplementary patent certificate (SPC) in certain European countries expiring in February 2013 and in Australia by an s70 patent term extension expiring in March 2013.
  •     Genericsweb’s proprietary SPC analyser identified and flagged a discrepancy with the market authorisation date used for the application of the German SPC.
  •     The patent term was not extended by SPC in France or the UK as Ziprasidone is currently not market authorised in these countries.
  •     API patent protection expired in the US in March 2012, after benefiting from a full 5 years of patent term extension.
  •      In the US Lupin Pharms, Apotex and Dr Reddy’s Lab gained market authorisation upon expiry of the molecule patent and Sandoz in June.
  •     Ziprasidone is not an authorised medicine in the UK, however several generic companies have been identified in Europe holding market authorisation for Ziprasidone capsules.
  •     No generics have been identified in Canada nor in Australia.
  •     Almost one third of patent applications were filed by the innovator Pfizer and the prominence of generic filing in the top 5.
  •     After the launch, Generic companies filled a large number of authorisations for molecule, process and formulation patent, in an attempt to develop and protect their own technologies and circumvent innovator patents.
  •     There is a lack of patenting activity by generic companies relating to oral suspension or the injectable formulations.

GenericsWeb notes that: “the API patent remains in force in Europe and Australia posing a significant barrier to the launch of generics. Loss of API patent exclusivity in the US has seen the entry of generic competitors and this is likely to be the case in Europe and other markets. Pfizer have gone to significant lengths to maintain their monopoly for Ziprasidone, by developing and patenting different formulations. Pfizer still have exclusivity for IM injectable and oral suspension dosage forms. There is currently no evidence of any market authorisation obtained by generic companies for these dosage forms, suggesting the difficulty in developing aqueous Ziprasidone formulations and circumventing innovator patents.”

You can read the entire article here at: http://www.genericsweb.com/druginfocus/Ziprasidone

GenericsWeb, the leader in pharmaceutical patent analysis and searching holds an impeccable track record in providing quality patent information, and has allowed numerous pharmaceutical companies to successfully navigate intellectual property hazards. GenericsWeb is headquartered in Sydney, Australia, with offices in North America and Europe. All staff are highly skilled and experienced internationally and have extensive experience in pharmaceutical sciences and patent searching. For more information, visit the company's web site at http://www.genericsweb.com

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Yoann Bretonnet
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