Ranbaxy generic Lipitor launch delayed as Watson launches authorized generic

FDA holds off on giving Indian drug maker final go-ahead, according to published reports

NEW YORK — Ranbaxy Labs was supposed to launch its generic version of the world's top-selling drug Wednesday, but a competitor beat it to the punch as the former waits for final Food and Drug Administration clearance.

Watson Pharmaceuticals announced Wednesday the launch of an authorized generic of Pfizer's cholesterol medication Lipitor (atorvastatin) as the drug lost patent protection. Unlike generic drugs, which require FDA approval and are marketed in competition with their branded counterparts, authorized generics are branded drugs marketed under their generic names at a reduced price, usually by third-party companies under contract with the branded drug's original manufacturer.

Meanwhile, the FDA has delayed final marketing approval of Ranbaxy's generic, according to published reports, due to continuing disputes over quality-control problems that arose at two of the company's Indian manufacturing plants in 2008. In response to the issues, the FDA barred Ranbaxy from marketing 30 drugs and also stopped approving drugs that came from the plant.

When Ranbaxy does launch its version of Lipitor, which IMS Health estimated to have had sales of $7.8 billion during the 12-month period ended in September, it will still be entitled to 180 days of market exclusivity, and the FDA can't approve additional generic versions from other companies until the exclusivity period expires. But even after the FDA allows Ranbaxy to start selling the drug, the company will continue to face competition from Watson's authorized generic as well as Pfizer, which plans to sell the original branded drug at reduced prices to consumers through partnerships with Diplomat Specialty Pharmacy and several pharmacy benefit managers.

The Generic Pharmaceutical Association heralded the launch of the authorized generic. The organization, which lobbies on behalf of the generic drug industry, is opposed to authorized generics being launched during a generic drug's 180-day exclusivity period, but said the added competition would bring down the price and was thus beneficial.

"In this case, the first filer does not yet have approval, but the fact that there's competition in the marketplace is a big win for consumers," GPhA executive director Bob Billings told Drug Store News.


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