2015 Top 20 Companies: Otsuka


18. Otsuka  $8.2B ▲21.0%

Global revenue: $12.3B (19th); up 14.1%
Top brands: Abilify ($7.8B)
Promotional spend: $361M (18th); 4.4% of rev.
R&D spend: $2.4B (14th); up 20.0%; 19.5% of rev.
Planned launches: TAS-102 (onc.); OPC-34712 (CNS); Sativex (CNS); OPC-67683 (I.D.)
Patent expirations: Abilify (2015); Samsca (2015)

Otsuka faces the industry's steepest patent cliff this year when it loses exclusivity to Abilify. Second only to Gilead's Sovaldi in earnings, the antidepressant generated $7.8 billion in 2014, accounting for more than half of Otsuka's revenue. Softening the blow a little, Abilify received orphan-drug approval for treating pediatric Tourette syndrome in December. However, when the FDA expanded that indication to include adult Tourette's patients, Otsuka cried foul, arguing it would invalidate the seven-year exclusivity for pediatric use. The matter is pending in federal court. In other news, the FDA granted fast-track designation to the company's oral cancer therapy, TAS-100, which launched in Japan last year.

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