Lipitor Maker Facing Patent Expiration

LA Patent LawyerLos Angeles – Lipitor manufacturer Pfizer, Inc. faces the expiration of a key patent to the manufacture of its signature cholesterol medication in November 2011. In anticipation of the expiration of the patent term, generic drug makers are set to release generic versions of the atorvastatin as soon as November 30, 2011. Pfizer has now brought an action against rival drug company Merck & Co. who plans to combine a generic version of Lipitor with Merck’s drug, Zetia.

Pfizer’s lawsuit seeks an injunction to prevent Merck from using a generic version of Lipitor in the drug combination. Lipitor, an atorvastatin, is known as the bestselling drug of all time, experiencing sales of over $10 billion internationally in 2010. Merck, who has experienced success with Zetia, (over $2 billion in sales in 2010) believes that the combination of generic Lipitor and Zetia will work on two fronts to treat high blood cholesterol. Lipitor works by blocking enzymes in the liver while Zetia blocks the absorption of cholesterol from food. Merck hopes to achieve significant sales by combining the two processes into a complete cholesterol medication.

Unlike trade secrets and trademarks which can last indefinitely, patents have a very specific term length usually 20 years from the date of first filing depending on factors such as the type of patent. In order to maintain some continuous protection over its Lipitor product, Pfizer has filed for several different patents as recently as 15 years ago to protect different aspects of the drug. Some of Pfizer’s Lipitor patents have already expired and generics are simply waiting for FDA approval to launch their products.

On November 30, generics will have the ability to recreate the basic ingredients of Lipitor. However, Lipitor’s crystalline structure is patented until its expiration in 2017. Pfizer is asking the Delaware court to delay Merck’s combination drug for five years, until the crystalline structure patent expires. Merck, nevertheless, has already issued statements stating that it does not plan to use the crystal structure of Lipitor in its combination drug for the time being. Instead, Merck plans to use only the basic ingredients of Lipitor.

Meanwhile, as the Lipitor patent expires, both Merck and Pfizer will experience stiff competition from a range of generics offering atorvastatin at a low price.




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