The trend towards generic drugs is nothing new. It does not matter if a drug has billions of dollars in annual sales or not, when they go off patent generics can enter the market. Now the question is whether schizophrenia and bipolar disorder patients will trust generic Abilify or not.
The U.S. Food and Drug Administration (FDA) announced on Tuesday that it has approved the first generic versions of Abilify. Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder.
Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceutical Industries, Ltd. (NYSE: TEVA) and Torrent Pharmaceuticals Ltd. have received FDA approval to market generic aripiprazole in multiple strengths and dosage forms.
At one point, some 25% of Otsuka, the Japanese drug group, annual sales. Bristol-Myers Squibb Co. (NYSE: BMY). Otsuka’s sales partner, generated some $554 million in global sales of Abilify in the first quarter of 2015 alone — with some $508 million being in the U.S. alone. Bristol-Myers Squibb’s 2014 annual report showed that annual Abilify sales were $2.02 billion in 2014, $2.29 billion in 2013, and $2.83 billion in 2012.
The FDA release explains that Schizophrenia is a chronic, severe and disabling brain disorder, affecting about 1% of Americans. Symptoms of schizophrenia include hearing voices, believing other people are reading their minds or controlling thoughts and being suspicious or withdrawn. The FDA continued:
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. The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.
The FDA’s release also said that generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs, and that the manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.
Whether the generic drugs are supposed to be the same as brand drugs or not, many consumers prefer to not go to generic drugs for years. That being said, their insurance companies try to move them over to generics almost immediately.