There is on-going development of generic EU CTD Dossier of Atorvastatin, tablets, 10/20/40/80 mg.
Development of this pharmaceutical is carried out according to EU-requirements in country without patent protection or with Bolar-provisions. There will be no sales in those countries where this offer would constitute an infringement of third parties intellectual proprietary rights.
Atorvastatin (INN) (Lipitor, Pfizer), is a member of the drug class known as statins, used for lowering blood cholesterol. It also stabilizes plaque and prevents strokes through anti-inflammatory and other mechanisms.
Atorvastatin inhibits HMG-CoA reductase, the rate-determining enzyme located in hepatic tissue that produces mevalonate, a small molecule used in the synthesis of cholesterol and other mevalonate derivatives. This lowers the amount of cholesterol produced which in turn lowers the total amount of LDL cholesterol. Atorvastatin was first synthesized in 1985 by Bruce Roth while working at Parke-Davis Warner-Lambert Company (now Pfizer). With 2008 sales of US$12.4 billion, Lipitor is likely the top-selling drug in the world. US patent protection is scheduled to expire in June 2011. However, Pfizer made an agreement with Ranbaxy Laboratories to delay the generic launch in the US until November 2011.
More details at: http://www.rxlist.com/lipitor-drug.htm.
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