Company: Eli Lilly
2020 sales: $5.1B
Key patent expirations: 2027 to 2029
Eli Lilly has leaned on a brigade of drugs approved since 2014 to drive its growth, and Type 2 diabetes blockbuster Trulicity has stood chiefly among them.
Despite pandemic stumbles in the third quarter last year, the once-weekly injectable—Lilly’s best seller—managed to post a 24% overall sales increase in 2020 to $5.07 billion. That made Trulicity the 15th best-selling drug in the world last year and marked the first time the med crossed $5 billion in sales.
The Indianapolis-based drugmaker desperately needed the GLP-1 drug Trulicity when it first arrived on the scene seven years ago. The company had just lost patent protections on two of its biggest stars, anti-depressant Cymbalta and osteoporosis treatment Evista, which took a deep cut at Lilly's sales.
But even Trulicity’s clock is slowly running out, with generic competition slated to enter the market later this decade, Moody's analysts said. Lilly has tried to get ahead and is hard at work developing what it hopes to be its next diabetes heavyweight, the dual GIP/GLP-1 agonist tirzepatide.
That medicine significantly reduced blood sugar and body weight in Type 2 diabetics, according to late-phase clinical trial data released late last year. Even as Trulicity sales keep growing, the drugmaker now plans to pit tirzepatide against Trulicity in a head-to-head 12,500-patient trial.
If tirzepatide’s phase 3 program goes well, Lilly could emerge with a drug that protects it from the anticipated loss of Trulicity patent protection and provides a real threat to its rivals, notably Novo Nordisk’s Ozempic and Rybelsus.
But Novo's Ozempic is starting to apply more pressure on Trulicity, and even its dual-action hopeful tirzepatide. In a late-stage study, a higher 2 mg Ozempic dose topped a 1-mg predecessor on blood sugar reduction with no added side effects, according to results recently presented at the American Diabetes Association’s 2021 virtual scientific sessions. The higher dose also helped patients lose more weight when taken as directed.
That was welcome news after Novo resubmitted its FDA application for the once-weekly 2-mg dose in May. Both Novo and Lilly, which scored a win for 3-mg and 4.5-mg doses in January, have been pushing higher dose versions, but analysts see more opportunity in the lower-dose arena since they usually come with fewer side effects.
Lilly's tirzepatide already topped Novo's standard 1-mg dose in a head-to-head this year, but the jury's still out on how well it would perform against the 2-mg dose currently awaiting the FDA's decision.
For now, Lilly is still riding high with Trulicity. In February 2020, the drug won a highly anticipated FDA nod to reduce the risk of cardiovascular events in Type 2 diabetes patients regardless of whether they have established cardiovascular disease.
The company has been “particularly encouraged” with Trulicity’s performance and its ability to take over nearly half of the injectable market, Lilly CFO Anat Ashkenazi said during the company’s first-quarter earnings call in late April.
As Lilly awaits more tirzepatide readouts, the company will “remain focused on sustaining Trulicity's leadership position, accelerating class growth and providing continued innovation in the incretin space,” Ashkenazi said.