Abilify (aripiprazole)
Companies: Otsuka/Bristol-Myers Squibb
Disease: Schizophrenia and other neurological conditions
Global 2013 sales: $7.8 billion
U.S. patent expiration date: April 2015

The end of Abilify exclusivity in the U.S. is going to create a big revenue hole for both Bristol-Myers Squibb ($BMY) and Otsuka. The former garnered $2.3 billion from sales of the antipsychotic drug last year; that accounted for 14% of total sales. As for Otsuka, Abilify made up a full one-quarter of its sales.

Previously, the pair had successfully fought off a patent challenge from Teva Pharmaceutical Industries ($TEVA) and Apotex. BMS also won the right from the courts last year for a coupon program for Abilify to help it fend off generic competition by making the drug relatively more affordable to consumers. But ultimately, BMS knows its pipeline has to fill the revenue gap.

"Obviously, the end of Abilify is a very clear date in the middle of next year," BMS COO Dr. Giovanni Caforio said at the Morgan Stanley Healthcare Conference in September. "So, as a result of that, obviously in the next 12 months to 24 months, there is an evolution and a transition in our portfolio, which we are managing very carefully, but as I said before, our number one priority remains to invest behind all of the opportunities we have, because we are very focused on driving growth beyond 2015."

Investors don't seem terribly convinced that the pipeline is ready to drive continued growth; the company's share price is almost precisely where it was last fall. For the few years before that, BMS was an investor favorite with one of the best share price performance records among the ranks of its pharma peers, as investors advocated the pharma's nimble approach to R&D and acquisitions. The recent lag is despite marked enthusiasm for its PD-1 candidate nivolumab, which it has pledged to start in a Phase III combo trial with its Yervoy before year end.

For its part, Otsuka is focused on life-cycle management with a once-monthly injection of Abilify that resulted from a partnership with Danish drugmaker Lundbeck. Dubbed Abilify Maintena, this version won U.S. and European approvals last year.

For more:
Otsuka spends $3.5B for Avanir--and patent-cliff protection
Bristol-Myers, Otsuka ask judge to nix Abilify kickback suit
Bristol-Myers' Abilify coupons prevail in health-plan lawsuit

-- Stacy Lawrence (email | Twitter)