Generic player Ratiopharm Canada has won a five-year long legal battle against innovator Pfizer’s key patent covering Amlodipine besylate (Norvsac). The said decision will allow the marketing of Amlodipine Besylate (Norvasc) 2.5 mg, 5 mg and 10 mg tablets by generic manufacturers.
Generic player Ratiopharm challenged the following patent in 2004 :
CA1321393 (Expiry: August, 2010): which covers A process for preparing the besylate salt ofamlodipine characterised by the steps of reactingamlodipine base with a solution of benzenesulphonic acid or its ammonium salt in an inert solvent and recoveringthe besylate salt of amlodipine.
As per the Federal Court's decision announced on July 8, 2009 by Honorable Judge Roger Hughes, the disputed patent was declared invalid.
Ratiopharm was the first company to challenge the Amlodipine Besylate patent in 2004 and got favorable decision from Federal Court in February, 2006. Later on, Pfizer appealed the decision in the ratiopharm case and won the appeal.
Pfizer will appeal against said decision as reported by fiercebiotech Here
Link to Bloomberg news Here
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