Generics giant Teva Pharmaceutical Industries is all 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 Food and Drug Administration has granted tentative approval for its version of Lipitor (atorvastatin), Pfizer's cholesterol blockbuster which had annual 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, ie in May.

The Petah Tikva-headquartered firm is already profiting from Ranbaxy's first-to-file status. Hours after the Indian drugmaker received final approval from the FDA, the Indian drugmaker revealed it has 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 be disclosed, so it is not clear whether the firms have signed a marketing or distribution pact or whether Teva is involved in manufacturing.

Senators question Pfizer strategy

Meantime, amid all the excitement, 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 see them offer patients branded Lipitor at much lower prices.

This strategy has prompted the politicians - Senate finance committee chairman Max Baucus, senior finance committee member Chuck Grassley and special committee on ageing chairman Herb Kohl - to send letters to Pfizer, three PBMs and two insurance companies asking for information about the agreements.

Sen Baucus wrote 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".  He added that "we need to take a close look to ensure we’re protecting both taxpayer dollars and access to the medicine patients need".

Pfizer responded by saying 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 says 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, as well as Teva, several other generics firms are expected to start selling their versions.