David Smart /
11 March 2015Americas

Otsuka sues Wockhardt to protect Abilify

Japanese company Otsuka Pharmaceutical has sued drugs company Wockhardt for patent infringement at the US District Court for the District of New Jersey.

In its complaint, filed on Friday (March 6), Otsuka accused Wockhardt of infringing two patents that cover antidepressant drug Abilify (aripiprazole).

Wockhardt had filed an abbreviated new drug application (ANDA) at the US Food and Drug Administration (FDA) in which it sought approval to market a generic version of Abilify before two patents covering the drug expire.

Otsuka claimed that by filing the application Wockhardt had infringed its US patent number 7,053,092, called “5-HT1A receptor subtype agonist”, as well as its US patent 8,759,350, called “carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders”.

The patents are due to expire in January 2022 and March 2027 respectively. They are both listed in the FDA’s Orange Book in relation to an oral solution of Abilify, which was approved by the FDA in 2004.

In its complaint, Otsuka asked the court to find that Wockhardt has infringed the patents through its filing of the ANDA, and rule that any approval of Workhardt’s generic does not come into effect until after the two patents have expired.

Abilify is one of the world’s biggest selling drugs. In the 12 months to June 30, 2014, it generated worldwide sales of $7.2 billion. The main compound patent covering Abilify is due to expire in April this year.

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