FDA Approves Teva’s Generic Version of Lipitor

Generics major Teva Pharmaceutical Industries is set to enter the lucrative market created in the USA by the patent expiry on Pfizer’s Lipitor but not until Ranbaxy Laboratories’ 180-day exclusivity period runs out.

The Israeli drugmaker noted that the US FDA (Food and Drug Administration) have granted tentative approval for their generic version of Lipitor, Pfizer’s cholesterol blockbuster which had yearly sales of $7.8 billion in the USA as of September 2011.  Teva’s drug will be launched at the end of Ranbaxy’s six-month exclusivity.

People with high blood levels have a greater chance of getting heart disease. By itself, the condition normally has no signs or symptoms, meaning that many people do not know that their cholesterol levels are too high.

Teva are already profiting from Ranbaxy’s first-to-file status. Hours after the drugmaker received final approval from the FDA, Ranbaxy revealed that they had signed an agreement which will see Teva bank a portion of the profits from sales of atorvastatin during the 180-day exclusivity period.  Terms of the agreement were not disclosed.

Senators Question Pfizer’s Liptor Strategy

Meanwhile, three US senators have expressed concerns about Pfizer’s own tactics to retain as much revenue as possible from Lipitor.  The drugs giant has signed a number of pacts with health plans and pharmacy benefits managers which will result in them offering patients branded Lipitor at lower prices.

This strategy has prompted the senators to send letters to Pfizer, three PBMs and two insurance companies asking for information about the agreements.

Sen Baucus commented that “by working with manufacturers to push brand-name drugs, drug benefit companies may be abusing Medicare to boost their profits and denying generic alternatives to patients – a practice that needs to end immediately.”

Pfizer replied commenting that the senators’ letter is based upon an article published in the New York Times earlier this month which contained “incomplete and incorrect information about our Lipitor programmes.”  The company said its intention is to offer Lipitor at or below the cost of generic atorvastatin during the 180-day period and participation by a health plan is voluntary.

After the exclusivity period ends, several generics firms are expected to start selling their versions of the product.



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