Ranbaxy's FDA problems stymie launch of generic Nexium and the relief it would bring to consumers

Ranbaxy Laboratories, operating under the yoke of four FDA plant bans, has been unable to find a strategy that will allow it to launch three blockbuster for which it has exclusives. AstraZeneca's ($AZN) heartburn medicine Nexium went off patent several weeks ago and Ranbaxy should have a generic on the market. That is because the plant where it makes the active pharmaceutical ingredient is banned from shipping product to the U.S. as is the plant where Ranbaxy was expected to make the formulated version.

Ranbaxy has already missed launches of two other big sellers, Novartis' ($NVS) blockbuster heart drug Diovan went off patent in September 2012 and Roche's ($RHBBY) antiviral Valcyte went off patent last year. Ranbaxy has the 180-day exclusives for those drugs as well, granted to the generic drugmaker with the first generic application filed and approved.

FDA Commissioner Margaret Hamburg--FiercePharma file photo
FDA Commissioner Margaret Hamburg

The Indian drugmaker has reportedly been looking for ways to get the products to market despite the ongoing bans by the FDA of four of 5 of its FDA-approved facilities. Only its Ohm Laboratories plant in New Jersey is still able to produce for the U.S. market. Executives asked FDA Commissioner Margaret Hamburg during her visit to India in February to cut it some slack on its plants so it could get the blockbusters to market, but she reportedly politely declined the suggestion. Sources have also said that the drugmaker was talking with the FDA about how it might produce Diovan at its Ohm plant and also that it was out shopping for the API for Nexium from another producer. So far, those efforts have not resulted in any reported movement on the products.

Meanwhile, U.S. consumers, insurers and the federal government are spending billions of dollars more for products than they would have. The issue also has spotlighted what some see as a flaw in the system. The FDA is unable to cancel Ranbaxy's first-to-file exclusives and hand them off to other generic drugmakers, whose own products are on hold until Ranbaxy's exclusivity period has run. Mylan ($MYL) tried suing for the right over Diovan but had its suit dismissed. A citizen's petition was filed with the FDA last month over the entire situation but the FDA has yet to respond to that.

Columbia Law School professor Scott Hemphill told The Wall Street Journal that the delay of the launches raises "a serious question over whether the rules are too complex to manage, or to anticipate strange, unusual and unfortunate consequences that result from them."

- here's the WSJ story