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.
As Reuters reports, U.S. District Judge George Hazel rejected Otsuka's argument that its 7-year orphan drug exclusivity for Abilify--in pediatric Tourette syndrome--should protect the antipsychotic drug from competition. Abilify's other approved indications aren't protected by that orphan-drug status, Hazel pointed out. And that means companies such as Alembic Pharmaceuticals, Teva Pharmaceuticals ($TEVA), Hetero Labs and Torrent Pharmaceuticals can move ahead with generics.
Otsuka is reviewing the judge's decision and considering its options, a company spokesman told the news service.
The decision comes a month after Otsuka and its marketing partner Bristol-Myers Squibb ($BMY) suffered FDA approval for Abilify generics. Otsuka struck back, filing a motion to block Abilify copies from entering the market. But Hazel shot down the company's original request for an injunction and has now issued his final no.
Mainly used to treat schizophrenia and bipolar disorder, Abilify has brought in billions for Otsuka and BMS--and now that sales flow will be ebbing away. Otsuka has tried to soften the blow, signing a $3.5 billion agreement in December to pick up Avanir Pharmaceuticals. The acquisition could help Otsuka as generics cut into Abilify, which accounted for about 40% of the company's haul in 2013.
BMS expects a major sales hit this year, too, projecting companywide revenue of $15 million max. The drug already faces competition from a longer-acting injected version, Abilify Maintena, sold by Danish drugmaker Lundbeck and Otsuka. But BMS is hoping that newer products, such as Opdivo and Eliquis, will add salve to the wound.
- read the Reuters story
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