Innovator AstraZeneca's blockbuster stomach ulcer and acid reflux molecule Esomeprazole magnesium (Nexium) faces early generic competition in Denmark, where Sandoz launched a generic version this week.
An AstraZeneca spokesman said on Thursday the group was aware of the launch, adding that authorisations for generic forms of the medicine had also been granted in Ireland, Portugal, Austria, Hungary, Estonia, Latvia, Lithuania, Finland and Slovenia.
In major European countries, however, the product is still protected by market exclusivity that only expires in March 2010. (Source: Reuters article Here )
Further, generic players have opposed key patents of innovator in EU market like EP00652872 (revoked by EPO) and EP00773940.
In US market, innovator has fared well and was successful in blocking generic challenge. Generic players like Sandoz, Dr. Reddy and Ivax challenged innovator but have not succeded till date. Also, the first para IV filer Ranbaxy settled patent litigation with innovator and would be able to launch generic version under licencing agreement from May, 2014 onwards. Innovator Astra has strong patent portfolio for this product.
Earlier news of Ippharmadoc on this product Here
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