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