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Augmentin patent ruling

Executive Summary

Four generic versions of Augmentin will remain on the market following a Federal Circuit decision that affirmed a ruling invalidating GlaxoSmithKline's patents for nonstatutory double patenting. Novartis' Geneva division launched the first generic version of the antibiotic in June 2002. Ranbaxy, Teva and Novartis' Lek division also market generic amoxicillin/clavulanate. Novartis has been placing Geneva's earnings from the generic in reserve in case the company lost the appeal (1"The Pink Sheet" Aug. 5, 2002, p. 35)...

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Geneva Augmentin generic reserve: Geneva's generic amoxicillin/clavulanate earnings are being placed in a reserve in the event the company loses GlaxoSmithKline's appeal of the Augmentin patent lawsuit, Novartis CEO Daniel Vasella said July 22. "We will book sales, but we will not book the earnings out of this product but put them in a reserve," the exec said. "The additional exposure should we - against all odds - lose the appeal next year, would be an amount which we can digest, I would say, rather easily." GSK is appealing a May 22 ruling in Geneva's favor; a decision could come as early as January (1"The Pink Sheet" May 27, p. 20). Geneva launched amoxicillin generics in June...

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QUOTED. 13 April 2021. US FDA.

As medical organizations such as the Veterans Health Administration and Mayo Clinic are positioning themselves to become medical device manufacturers using 3D printing technologies, it opens challenges and opportunities. See what Mayo Clinic’s Sean McEligot said about it here.

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