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Mylan in and out of hot water Posted 18/03/2011

On 26 January 2011 Mylan, the second-largest US generics manufacturer, announced a truce with global pharma giant Pfizer, which will enable the former to sell generic versions of the cholesterol drug Lipitor (atorvastatin) and combination blood pressure and cholesterol treatment Caduet (amlodipine/atorvastatin).

Pfizer sued Mylan early last year for patent infringement, after the company filed an Abbreviated New Drug Application (ANDA) with the FDA. Generic Caduet may be marketed from 30 November 2011, or earlier under ‘certain circumstances’ which both parties are keeping confidential; the agreement itself is subject to review by the US Department of Justice and the Federal Trade Commission. Lipitor’s patent expires later this year and several generic versions are anticipated by November.


On 17 December 2010 Shionogi Pharma filed a patent-infringement lawsuit against Mylan to prevent the generics manufacturer from gaining approval for its version of the anti-inflammatory drug Orapred ODT (prednisolone). The company is seeking an injunction to prevent Mylan from marketing or manufacturing its generic prednisolone until the patent expires in November 2019, in response to the drugmaker's ANDA.

Mylan believes it is the first company to have filed a substantially complete ANDA for this drug containing a Paragraph IV certification for the specified strengths and therefore expects to qualify for 180 days of marketing exclusivity upon final FDA approval. As of January 2011 Mylan had 170 ANDAs pending FDA approval representing US$97.7 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing US$24.2 billion in annual brand sales. These figures are taken from the company website, but quote out-of-date IMS estimates. They nevertheless give the picture of Mylan being very active in pursuing its strategy of ‘first generic to market’ and the website also shows several FDA approvals and launches this year already.

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Source: IBTimes, Mylan, News-Medical

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