In Last-Ditch Effort to Salvage Blockbuster Drug, Teva Sues the FDA

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In a last-ditch attempt to prevent generic versions of its multiple sclerosis drug, Copaxone, Teva Pharmaceutical Industries (NYSE:TEVA) has decided to sue U.S. regulators, claiming that the Food and Drug Administration wrongly dismissed the drug maker’s request to subject competitors’ generic versions of Copaxone to extensive testing.

Last month, Teva appealed to the Supreme Court, seeking an injunction that would prevent the sale of the competing generic versions of the drug on May 24, Copaxone’s patent expiration date. A Supreme Court justice rejected the appeal, and now Teva, with mere weeks to go before Copaxone’s impending patent expiry, is getting desperate.

There is no question that the agency’s actions violate Teva’s statutory right to receive a decision on the merits of its petition within the law’s statutory deadline,” Teva’s complaint reads, per Bloomberg.

Copaxone, which was first approved by the FDA in 1997, accounts for more than half the company’s revenue. Bloomberg reports that the drug currently brings in approximately $3.2 billion in annual sales, and as a result, Teva is eager to delay the release of generic versions, partially in order to buy itself time to convince physicians and patients alike to switch to a newer, higher-dose version of the branded drug.

The 40-milligram version of Copaxone is covered by a new patent until 2015, and while Teva expects that it will take a loss following the expiration of the 20-milligram version of the drug, the drug maker argues it needs all the time it can get. According to the company, if Copaxone’s patent expires before Teva is able to sell its higher-dose alternative, the company will suffer “irreperable harm.”

“Unless the court acts now, the FDA’s gamesmanship will preclude Teva from obtaining meaningful judicial review before the FDA allows these putative generic products to overwhelm the market,” Teva’s complaint reads, according to Bloomberg.

As noted in earlier reports, generic drugmakers like Novartis AG’s Sandoz Inc. and Mylan Inc. both have generic versions of Copaxone ready and waiting for a May 24 launch date. Thus far, no one quite knows whether those companies will go ahead and release generic versions as planned or wait until Teva’s hullabaloo with regulators is officially put to bed.

Should Sandoz and Mylan choose to release their products on Copaxone’s previously established patent expiry date, the companies risk having to pay Teva damages if, after the fact, the U.S. Supreme Court decides to rule in favor of the Israeli drugmaker. Teva notes, however, that even if the company receives damages, the launch of the generics could cause the company massive losses of hundreds of millions of dollars.

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