Reports: Otsuka can block Apotex’s generic version of Abilify
NEW YORK — Drug maker Otsuka Pharmaceuticals can keep generic versions of its schizophrenia drug off the market, according to published reports.
Bloomberg reported that the Supreme Court upheld a ruling that allowed Otsuka to block Canadian generic drug maker Apotex from marketing a version of the antipsychotic Abilify (aripiprazole), which Otsuka co-markets with Bristol-Myers Squibb.
Apotex attempted to argue that because any person with the right skills could create a version of Abilify’s active ingredient sufficiently identical to the original, and that the ingredient belonged to a class of drugs that had existed since the early 1980s. But the high court upheld a ruling in a lower court rejecting those claims.
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Reports: Alabama man can sue branded drug makers over generic drug side effects
NEW YORK — The state supreme court in Alabama ruled that brand-name drug companies could be sued if patients suffer complications from generic versions of their medicines, according to published reports.
According to The New York Times, an Alabama man named Danny Weeks claimed he developed tardive dyskinesia after taking generic versions of Pfizer’s acid reflux drug Reglan (metoclopramide). Pfizer acquired rights to the drug when it bought Wyeth in 2009, and generic drug makers Teva and Actavis, now owned by Watson, make generic versions.
Weeks had originally filed the suit in federal court, but the court asked the Alabama Supreme Court to determine if Weeks could sue the branded drug makers.
Under Food and Drug Administration regulations, generic versions of branded drugs must use the same safety labeling as the branded versions, and the Times noted that a 2011 Supreme Court decision, Pliva v. Mensing, determined that generic drug companies had no control over what drug labels said, meaning they could be sued for failing to inform patients of safety risks.
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Switching to multi-pill generic HIV treatment could diminish effectiveness, study finds
NEW YORK — While replacing a single combination pill for HIV with generics would save the healthcare system money, it could also diminish the effectiveness of treatment, a new study suggests.
The study, led by investigators at the Massachusetts General Hospital and Weill Cornell Medical College, and published in the Jan. 15 issue of Annals of Internal Medicine, found $1 billion in potential savings, but the more complicated treatment regimen might result in more patients missing doses and a loss of drug effectiveness.
Currently, the recommended treatment for newly diagnosed patients is Gilead Sciences’ and Bristol-Myers Squibb’s Atripla, which combines three branded antiretrovirals — Viread (tenofovir), Emtriva (emtricitabine) and Sustiva (efavirenz) into one pill. A generic version of lamivudine, which has a similar mechanism of action to emtricitabine, became available in January 2012, and a generic version of efavirenz is expected to become available soon.
The issue, the authors wrote, is that while replacing two of the three drugs in Atripla with generics might be cheaper, it would also make treatment more complex, with patients having to take three pills instead of one, thus increasing the risk of missed doses. In addition, the authors wrote, lab studies have indicated that lamivudine may be slightly less effective and more vulnerable to drug-resistant strains of HIV than emtricitabine.
The researchers employed a widely used mathematical model of HIV progression to simulate the effects of a daily three-pill regimen of generic efavirenz and lamivudine plus Viread, compared with the current one-pill combination, adopting a worst-case scenario to project the efficacy of the generics and their effect on viral resistance. Results indicated that switching all HIV patients in the country to the three-drug generic therapy would save $42,500 per eligible patient and $1 billion nationwide, but reduce quality-adjusted life expectancy by as much as 4.5 months.
"The switch from branded to generic antiretrovirals would place us in the uncomfortable position of trading some losses of both quality and quantity of life for a large potential dollar savings," study lead author Rochelle Walensky of Massachusetts General Hospital said. "By estimating the likely magnitude of these offsetting effects now — before generic antiretrovirals actually hit the shelves — we can confront our willingness as clinicians, patients and as a society to make these difficult choices."