Otsuka has finally lost its battle with the FDA to prevent generics of its antipsychotic Abilify from hitting the market. A federal judge issued a final ruling against the Japanese drugmaker, a little more than a month after regulators opened the door for copycat versions of the meds.
A U.S. federal court ruled against Japan's Otsuka Pharmaceutical in an intricate court case involving an orphan drug, several patents and generics approvals. All of that was involved in a suit against the U.S. FDA.
Otsuka has already sued the FDA to block generic versions of the blockbuster antipsychotic Abilify, claiming that its orphan drug exclusivity on one indication should preclude copycat meds entirely.
Bristol-Myers Squibb and Otsuka won't have to fight claims that they promoted Abilify for off-label uses or used kickbacks to persuade doctors to prescribe the antipsychotic drug. A U.S. judge tossed out those allegations, leveled by a couple of whistleblowers in 2011, for lack of specific evidence.
Taiho Pharma Europe Ltd., a subsidiary of Japan based Taiho Pharmaceutical Co., Ltd., has submitted a Marketing Authorization Application to the European Medicines Agency for TAS-102, an oral combination anticancer drug intended for use in the treatment of refractory metastatic colorectal cancer.
SINGAPORE-- On Feb. 11, Otsuka Pharmaceutical appointed a new president, Tatsuo Higuchi, already president and CEO of the parent holding company, to replace Taro Iwamoto, who died two days earlier.
Embattled biotech Ariad Pharmaceuticals has signed a deal with Japan's Otsuka to trade the Asian rights to its top cancer drug in exchange for $77.5 million and the promise of more down the line.
Avanir, which agreed to sell itself to Otsuka earlier this week for $3.5 billion, may have been able to snag another price, some analysts figure. Problem is, it may too late to do anything about it.
Otsuka's patent cliff is coming, with the expiration date on best-seller Abilify's IP shield just around the corner. But now, the Japanese pharma has signed a $3.5 billion agreement to pick up Avanir Pharmaceuticals that could help soften the blow.
Avanir has made something of a reputation for itself by mixing a pair of generics--a cough suppressant and an old heart medicine--into a new elixir that can calm an emotional outburst. And Japan's Otsuka has stepped in to snap up the company, its product and a pipeline of repurposed meds for a hefty $3.5 billion.