(PRWEB) May 17, 2012
The article by GenericsWeb highlights the following observations in relation to generic Clopidogrel:
The most constraining patent families generally preventing the launch of generics relate to the API, patents in these families protect both the racemic mixture of Clopidogrel (FR8212599A) and the enantiomerically pure form and its salts (FR8702025A).
Patents in family which claim the Clopidogrel molecule per se, have already expired. However, protection has been extended to 17 May 2012 in the US. The term of the equivalent European patent has also been extended by supplementary protection certificates (SPC) until 16 February 2013. The completion of an agreed Paediatric Investigational Plan (PIP) has resulted in applications for a further 6 month paediatric extension to SPCs in major European countries. However the scope of the patent offering protection in many European countries is restricted to the Clopidogrel bisulfate salt.
Family with priority FR9807464A claims polymorphic form II of Clopidogrel bisulfate is not considered to be a constraint as it is likely to be circumvented.
The presence of generics in Australia and Canada, prior to patent expiration, can be attributed to the revocation of patents AU597784 and CA1336777, both being found invalid.
Generic Clopidogrel equivalents using the besilate, hydrobromide or hydrochloride are available in the UK. UK Market authorisations have also been granted for generic equivalents using the bisulfate salt.
A diversity of applicants represented by the significant portion outside the top five have been identified as filing patent applications relating to Clopidogrel, focusing primarily on process patents, the majority of which relate to intermediates and methods of purification. Most of these have been filed by generic companies trying to circumvent innovator patents. 21% are by the innovator Sanofi.
There was a strong response by generic companies post-launch and in the lead up to the expiry of data exclusivity, particularly in new molecule forms and process patents.
Amongst the US approvals, tentative FDA approvals have been identified for generic Clopidogrel, awarded to Apotex, Dr Reddy’s, Mutual Pharma, Mylan, Roxane, Sun Pharma and Torrent.
GenericsWeb notes that: “Sanofi and Bristol Myers Squibb have gone to significant lengths to prevent the launch of generic Clopidogrel products by filing patent families protecting the racemic and enantiomerically pure Clopidogrel. The protection from the enantiomerically pure patent family will prevent the launch of a generic in US until its expiry in May 2012. In Europe, generic competitors have been able to circumvent API patents by using an alternate salt. Sanofi and Bristol Myers Squibb have gone to additional lengths to protect their monopoly for Clopidogrel beyond that of the API families, resulting in patent filings by generic competitors as they try to circumvent patents and protect their own technologies. Bristol Myers Squibb quite rightly anticipates significant decline in sales upon patent expiry in the US.”
You can read the entire article here at: http://www.genericsweb.com/druginfocus/Clopidogrel
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