last year, more than 12% of the company’s total sales of $15.9 billion.
Abilify’s total worldwide sales in the 12 months to June 2014 totalled $7.2 billion for BMS and Otsuka, which markets the drug with BMS, with the Japanese company claiming the bulk of the revenue. According to Otsuka, Abilify accounts for about 40% of its sales. In an effort to bolster its central nervous system (CNS) portfolio before Abilify’s US expiry in April, Otsuka bought Californian pharma company Avanir last December. Avanir has a pipeline of pre-approved drugs to treat CNS conditions including Alzheimer’s disease, Parkinson’s disease and migraine.
Avanir’s flagship product Nuedexta (dextromethorphan hydrobromide), which treats pseudobulbar affect, also known as emotional incontinence—a condition characterised by involuntary bouts of laughter or crying—made $94 million in sales in the 12 months to June 30, 2014. Avanir’s compound patent on Nuedexta does not expire until 2023. Also waiting in the wings is a ‘long-acting’ version of Abilify, called Abilify Maintena, which Otsuka developed with Danish pharma company Lundbeck. Maintena is a once- monthly injection of the medicine, which was approved by the FDA in February 2013.
At a glance Drug name Gleevec Lantus
Namenda Abilify
Avodart/Jalyn
Manufacturer Novartis Sanofi
Actavis/Forest Labs BMS/Otsuka
GlaxoSmithKline
Otsuka and Lundbeck are also lining up brexpiprazole which, like Abilify, treats schizophrenia and is an adjunctive therapy for major depression. Te FDA accepted it for review last September.
GlaxoSmithKline’s (GSK) pill for an enlarged prostate is due to lose patent protection in the US in November. It has proved itself to be a strong performer for GSK: the Avodart franchise, which includes combination pill Jalyn, made $1.2 billion worldwide last year, 4% down on 2013.
Date of expiry Jan 4, 2015 Feb 12, 2015 Apr 11, 2015 Apr 20, 2015 Nov 20, 2015
Te drug has undergone many challenges, however. In 2011, Watson (now Actavis) filed an Abbreviated New Drug Application with the FDA seeking approval to make and sell an Avodart generic. GSK responded by suing Watson shortly aſter. Te main Avodart/Jalyn patent has also been targeted in the US by Banner Pharmacaps, Anchen, Roxane Laboratories and Mylan. In January 2013, GSK and Anchen settled their US-based litigation on terms that allowed Anchen to enter the Jalyn market in the fourth quarter of 2015, or earlier under certain circumstances. GSK has also settled a challenge by Teva to Avodart, which means Teva can launch a generic version of Avodart in the US in late 2015 as well. Teva’s generic Avodart was FDA-approved in 2010.
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