Stampeding generics expected to trample Lilly's now-off-patent ADHD med Strattera

Lilly lost its Strattera monopoly Tuesday as the FDA approved four competitors from generics makers Apotex, Teva, Aurobindo and Glenmark. (Courtesy of Christian "VisualBeo" Horvat)

Eli Lilly’s big-earning ADHD med Strattera has succumbed to generics. Four drugmakers won FDA green lights for their copycats Tuesday, and the competitive pressure is expected to quickly tank the brand's sales.

Apotex, Teva Pharmaceutical Industries, Aurobindo and Glenmark made it past the FDA gatekeepers with their generics to a Lilly med that pulled in sales of $535 million in the U.S. and $854 million around the world last year.

Now, Strattera is set for a steep sales slide, according to the life sciences commercial intelligence firm Evaluate. Often, only one company launches a copycat as soon as a drug loses its U.S. exclusivity, thanks to first-to-file rules that give generics makers an exclusive of their own for six months. Branded drugmakers can then try to compete on price and retain some sales.

But that's not the case for Lilly here; with four generic players in the market comes a tougher competitive battle. Evaluate recently predicted Strattera’s U.S. sales will fall all the way to $13 million by 2022. Strattera first won FDA approval in 2002.

RELATED: Top 10 U.S. patent losses of 2017

Strattera isn't the only one of Lilly's brands to face a generic onslaught this year. Strattera’s 2016 sales were just enough to land it a spot on FiercePharma’s ranking of the top U.S. patent losses for 2017. Lilly’s erectile dysfunction med Cialis ranked second on that list, while the company’s blood thinner Effient is also set to lose exclusivity in 2017. Effient’s sales fell outside of the top 10, however.

Facing the upcoming patent expirations and a high-profile clinical failure in Alzheimer’s disease, the drugmaker late last year cut marketing positions and stopped promoting the three meds set for a loss of exclusivity.

RELATED: Eli Lilly targets sales force for job cuts in wake of Alzheimer's failure

But Eli Lilly isn’t alone in losing some important patents this year.  According to a recent report from Bernstein analyst Tim Anderson, Big Pharma faces a “patent cliff 2.0” in 2017 that will leave vulnerable $26.5 billion in annual sales, the highest amount until at least 2025.

Among the meds set to lose their solo position in the market are Roche’s Rituxan, GlaxoSmithKline’s Advair, AstraZeneca’s Byetta, Pfizer’s Viagra and Merck’s Vytorin, according to the report. Advair went off patent years ago, but the tough-to-copy med could face a substitutable generic for the first time this year.

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For Lilly, Strattera’s fall to generics follows the failure of an Alzheimer’s hopeful, solanezumab, in December and a more recent setback with rheumatoid arthritis med baricitinib, which the FDA rejected in April.

In the first quarter, facing challenges in diabetes and growing pricing scrutiny, the drugmaker reported strong uptake for once-weekly GLP-1 diabetes med Trulicity and psoriasis drug Taltz, while Humalog sales grew 17% to $708 million. All told, Lilly’s revenue grew 7% for the period and the drugmaker beat earnings expectations.