Aurobindo Pharma’s shares jumped 5 per cent on Friday after the drug firm received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market generic Aripiprazole tablet that is used for treatment of psychotic condition and that has big market in the US.
“The company has received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market Aripiprazole tablets… and the product is ready for launch,” said Aurobindo Pharma in its statement.
Market experts say that this is likely to be a big revenue generator for the company as it is only the fifth Indian drug manufacturer to have received the approval for the same.
“Some of the manufacturers have generated revenues of around $150 million in the last year from this drug and so the potential for Aurobindo Pharma is also big,” said a market expert who did not wish to be named.
The approval received is for tablets in the strengths of 2mg, 5mg, 10mg, 15mg, 20mg and 30mg. The approved ANDA (Abbreviated New Drug Application) is for the generic version of Otsuka Pharmaceutical’s Abilify tablets in the same strengths and its market size for the last 12 months is estimated at around $7.3 billion.
Aurobindo Pharma said that Aripiprazole tablets are atypical antipsychotic indicated in the treatment symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression). The firm now has a total of 215 ANDA approvals from USFDA.