Ranbaxy Laboratories has launched the first competing generic version of Pfizer's biggest selling drug the cholesterol lowering medicine Lipitor (atorvastatin).
Ranbaxy's generic product was approved yesterday by the US Food and Drug Administration (FDA) and is due for launch today. Approval comes despite recent manufacturing problems at a Ranbaxy plant in India regarding the submission of unreliable data.
Dr Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said the launch of generic competition for Lipitor would have benefits for patients in the US.
“This medication is widely used by people who must manage their high cholesterol over time, so it is important to have affordable treatment options. We are working very hard to get generic drugs to people as soon as the law will allow.”
Regulations allow Ranbaxy 180 day period of marketing exclusivity in the US for its generic Lipitor, due to being first to file with the FDA
A portion of the profits made from sales of Ranbaxy's atorvastatin in this period will be paid to Teva Pharmaceuticals, according to the company,.
Although terms of the agreement were not disclosed Deepak Malik, an analyst with Emkay Share & Stock Brokers, told Reuters it appeared to be a marketing and distribution tie-up that would enable Ranbaxy to “fight off competition from Pfizer and Watson better and gain a higher market share”.
Watson's version of the drug was developed as part of an exclusive agreement with Pfizer. The authorised generic version of atorvastatin will continue to be manufactured by Pfizer, but Watson will handle all marketing and distribution in the US.
Pfizer is to receive a share of sales from the sales of Watson's generic atorvastatin in the deal which runs until November 30, 2016.
Pfizer fights to hold onto Lipitor sales
Pfizer has implement a series of initiatives based on brand loyalty to the drug to lessen the impact the loss of Lipitor's patent will have on the company's finances.
This includes a series of discounting deals with pharmacy benefit managers and health insurers, including reduced co-payments for Pfizer's drug.
A mail-order service has also been set up to supply Lipitor, targeting patients who may be reluctant to switch brands.
But the company has an impossible task ahead and further generics are due to enter the market in the US after the loss of Ranbaxy's exclusivity, including a version of the drug by Mylan.
Sanofi has also been reported to be interested in making a generic atorvastatin product as part of a French programme offering tax rebates to the company who holds the rights to the original drug, in this case Pfizer, if production of its generic alternative is based in France.
In Europe, Pfizer extended the drug's patent protection by six months to May 2012, with the announcement of new paediatric data enabling the launch of a chewable grape-flavoured version of Lipitor for children in the EU by November 2011.
Generic versions of the drug have already been available in certain countries including Spain, Brazil and Mexico.
Despite a drop this year in Lipitor revenues, analysts IMS Health estimate the drug still brought Pfizer around $7.8bn in US sales in the 12 months to September 2011.