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FDA approves first generics of antipsychotic drug

Generics/News | Posted 04/05/2015 0 Post your comment

The US Food and Drug Administration (FDA) announced on 28 April 2015 the approval of the first generics of Otsuka Pharmaceutical’s schizophrenia drug Abilify (aripiprazole).

The aripiprazole generics are atypical antipsychotic drugs and have been approved to treat schizophrenia and bipolar disorder.

Generics makers Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals have all received FDA approval to market generic aripiprazole in multiple strengths and dosage forms.

Schizophrenia is a chronic, severe and disabling brain disorder, affecting about 1% of Americans, which can cause patients to hear voices, believe other people are reading their minds or controlling thoughts and being suspicious or withdrawn. Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks.

Abilify had 2014 sales of US$3.9 billion in the US, making it the sixth bestseller in the country, despite treating a relatively small proportion of the population (394,344 people in 2014) [1]. The US patent on Abilify expired on 20 April 2015, however, paediatric exclusivity extends until 20 October 2015.

The European Medicines Agency is also currently reviewing five generics of the speciality drug [2].

References
1. GaBI Online - Generics and Biosimilars Initiative. The cost of speciality pharmaceuticals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 4]. Available from: www.gabionline.net/Reports/The-cost-of-specialty-pharmaceuticals
2. GaBI Online - Generics and Biosimilars Initiative. Generics applications under review by EMA – December 2014 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 4]. Available from: www.gabionline.net/Generics/General/Generics-applications-under-review-by-EMA-December-2014

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Source: FDA