Bristol Myers Squibb Anticipates Significant Decline In Sales In The US For Clopidogrel
Sydney, Australia, April 2012 – 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 Sanofi and Bristol Myers Squibb’s blockbuster platelet aggregation inhibitor Clopidogrel (Plavix® and Isocover®). US sales increased by 8% in 2011, generating US$6.62 billion of the US$7.09 billion gained globally; resulting in a global sale increase of 6%. Sales in non-US markets declined 9%.
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.
• 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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Posted: May 2012
