Sydney, Australia (PRWEB) July 04, 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/Bristol Myers Squibb’s antihypertensive drug Irbesartan (Aprovel®/CoAprovel®, Avapro®/Avalide®, Karvea®/Karvezide®). Sanofi reported global Aprovel®/CoAprovel® sales of €1.29 billion in 2011, a decrease of 2.4% from 2010.
The article by GenericsWeb highlights the following observations in relation to generic Irbesartan:
- Patent protection for the Irbesartan molecule (FR9003563A) expired in Canada in March 2011 and the US in March 2012; meanwhile in Europe patent protection of the Irbesartan molecule has been extended by Supplementary Protection Certificates (SPC) which expires in August 2012.
- The Spanish portion of EP0454511 however only claims processes
- Additional SPCs expire in October 2013, but GenericsWeb’s proprietary SPC analyser had identified the basic patent as being a ‘C2’ category and therefore the SPC may be invalid.
- An s70 patent term extension protects the Irbesartan molecule from generic competition in Australia until February 2013.
- The patent family based on priority US47261895A claims formulations comprising Irbesartan and co-formulations with Hydrochlorothiazide but are not considered to be a constraint to generic competition as the protected technology is likely to be circumvented by re-formulation.
- Amongst the US approvals, Teva is the only generic competitor to launch upon molecule patent expiry, offering both the single active and combination products, thanks to their 180-day market exclusivity.
- The large number of generic authorisations awaiting launch in the UK and Australia is indicative of the likely competition the Aprovel® and CoAprovel® products will face upon extension expiry.
- Only a small number of the UK MA holders have been granted authorisations for the combination product, and so are poised to take advantage of the possibly weak SPC protection on this fixed dosage form and may launch upon expiry of the single-active SPC later this year, instead of waiting until 2013.
- A diversity of applicants represented by the significant portion outside the top five have been identified as filing patent applications relating to Irbesartan, focusing primarily on process and use patents, the majority of which relate to intermediates and methods of purification. There is a prominence of relevant applications filed by manufacturers of competing ‘sartan’ drugs.
GenericsWeb notes that: “Protection remains for the Irbesartan molecule in Europe as a result of SPCs and extended patents in Australia and as such represents a barrier to generic competitors. However, in certain European countries the basic molecule patent only protects processes for the preparation of Irbesartan and as such may have been circumvented, allowing generic competitors to launch prior to patent expiry. Strong generic competition is expected in Europe and other markets upon SPC expiry later this year, as evidenced by the volume of generic market authorisation holders in these markets. Further market pressure is expected in the US when other generic companies gain final market approval after the expiry of Teva’s 180-day market exclusivity period.”
You can read the entire article here at: http://www.genericsweb.com/druginfocus/Irbesartan
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