Swiss drugmaker Hoffmann-La Roche and Warner Chilcott Company have sued Sun Pharma Global Inc, an arm of Sun Pharmaceutical Industries, in the US for alleged patent infringement of Actonel (risedronate sodium tablets in 150 mg form), used for treating bone disorder disease osteoporosis.

The once a monthly dosage form, an improved version of Actonel, is manufactured and sold by Warner Chilcott and was approved by the US Food and Drug Administration (FDA) on April 22, 2008. Roche is the owner of the patent under dispute.

In December 2008, Sun had informed Roche and Procter and Gamble (last year, Warner Chilcott acquired Procter and Gamble’s prescription drug business for $3.1 billion) that it had submitted a marketing application to the FDA to sell a generic version of once a monthly form of the tablet, without challenging the patent of that drug.

Actonel and its various versions accounted for $1.4 billion of Procter and Gamble’s (P&G’s) prescription business of $2.3 billion in the year ended June 30, 2009. Actonel has patent validity till 2013 and beyond for various versions.

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Company Name CMP
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Dr. Reddys Lab 1275.05
Cipla 1520.55
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Lupin 2097.65
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