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Written by Zdravko Mauko

Thursday, 22 December 2005

Strategies for successful generic launch in European Union - Sildenafil case

The experts of Framvita.Net have made an brief analysis of current status of intellectual property and generic products about sildenafil. This article may help you in planning of successful launch of generic sildenafil in European Union. Rovinj

The patent for new chemical entity of sildenafil is EP-00463756 . Patentee is Pfizer Inc. Priority date is 20 Jun 90. This is patent for indication of hypertension, angina and arteriosclerosis. Indication of erectile dysfunction was covered by patent WO-09428902, with priority date of 13th May 1994. As usual, the patent situation is much more complicated because Pfizer holds about 40 patent families on sildenafil. There are numerous other companies with 23 additional patents families on sildenafil. Developer of generic product should carefully examine all this patents, taking special focus on API manufacturing processes, polymorphs, other product derivates, formulations and compositions. SPC for EP-00463756 will expire in-between 2013 and 2014 in number of EU countries. However, it seems that in Slovenia, Slovakia, Croatia, Bulgaria and Romania there is no national patent with link to EP-00247633, as primary patent. This opportunity has been used by PLIVA Pharmaceutical Industry from Croatia.

DINAMICO is the trade name for generic sildenafil marketed by PLIVA in Croatia, Product was launched in September 2004. Erectile dysfunction and men`s health problems are still tabu theme in Croatia. Health campaigns organized by PLIVA were oriented to general pubic and contributed that most of concerned people were addressed to their physician advice. During the campaign there have been published numerous articles in selected journals and through Croatian internet portals www.plivahealth.com and/or www.erekcija.com.hr. It has been issued brochure “Living with ED”.

According to information published by PLIVA, sales of Dinamico noted extraordinary results just 8 months after launching in Croatia. After this aggressive promotion of generic product, total sildenafile market increased for 51%, while Pfizer`s Viagra market share dropped for 24% (finally with March 2005.). Market share of Dinamico precedes to 60% actually.

It could be expected that other manufacturers of generic sildenafil will follow this example of Pliva and use Slovenia or Slovakia as Reference Member State for early start of Mutual Recognition Procedure in EU. More details about other strategies for early EU launch of generic pharmaceuticals are available at www.farmavita.net . Farmavit.Net is leading regulatory affairs network in central-east Europe.

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