Lilly's Strattera faces first wave of generic competition
- Eli Lilly saw the first copycats of its attention deficit hyperactivity disorder (ADHD) drug get the Food and Drug Administration's stamp of approval this week, meaning another hit to the big pharma's bottom lines isn't too far off.
- Four ex-U.S. drugmakers, Apotex, Aurobindo, Glenmark and Teva, received the thumbs up to market generic versions of Strattera (atomoxetine), the first non-stimulant drug green lit for ADHD patients. The treatment works by preventing neurons from reuptaking norepinephrine, which research has shown improves the attention spans of patients with the disease.
- While Strattera isn't one of Lilly's biggest revenue-generating drugs, it still managed to creep close to blockbuster status last year, with $855 million in sales — a particularly impressive feat given the drug has been on the market nearly 15 years.
Lilly has foreseen Strattera's loss of exclusivity for some time and has been preparing for the blow it would deal to the company's neuroscience portfolio, which is still reeling from the patent expiration of top-selling antidepressant Cymbalta (duloxetine) in the U.S. in 2013 and in European countries in 2014.
"We expect that the entry of generic competition following the loss of effective patent protection will cause a rapid and severe decline in revenue," the drugmaker said of Strattera in its latest Form 10-K filed with the Securities and Exchange Commission in February.
Strattera and Cymbalta were responsible for two-thirds, or a combined $1.79 billion, of Lilly's neuroscience revenue in 2016. But the unit's total sales have fallen about 25% over the past few years, underscoring the company's need to innovate.
A large chunk of that innovation has so far focused on Alzheimer's disease candidates like the once highly anticipated solanezumab. That space is highly risky, however, with an abundance of big clinical blow ups, so Lilly has also turned to pain and migraine medications as a means of beefing up its neurology offerings.
ADHD, meanwhile, looks to be less of a priority for Lilly. The Indianapolis-based drugmaker has investigated another norepinephrine reuptake inhibitor, Edivoxetine, as an ADHD treatment in a Phase 2/3 study, but terminated the trial because too few patients continued through its five-year duration and because its primary objective was not met.
Steering toward different central nervous system disorders may be a good choice for Lilly. Though the ADHD market is poised for growth, it is also packed with competition from powerful big pharmas and crafty biotechs. Novartis, Shire and Johnson & Johnson all have products that rake in hundreds of millions annually, while recent data from smaller companies such as NLS Pharma emphasizes the importance of developing treatments that have differentiated mechanisms of action.
Fortunately for Lilly, its other major portfolios in endocrinology, oncology and cardiovascular have all grown each year since 2013, providing at least some buffer to the declines seen in neuroscience.
Patent concerns, however, will surely weigh on the company's mind throughout this year. Its blockbuster erectile dysfunction drug Cialis (tadalafil) loses exclusivity in the U.S. and Europe in November, and its anti-blood clot medication Effient (prasugrel) loses exclusivity in the U.S. in October. Together, those products accounted for more than 93% of Lilly's revenues from the cardiovascular business.
- FDA Statement
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