10. Xarelto

Toward the end of 2019, Xarelto won the FDA's blessing to help prevent blood clots in acutely ill patients without a high risk of bleeding during or after their hospital stays.

As Bayer and Johnson & Johnson’s Xarelto inches toward a 2024 patent cliff, the drug remains on rocky footing. Once king of the warfarin alternative market, the blood thinner has increasingly taken a back seat to Pfizer and Bristol Myers Squibb’s Eliquis.

Altogether, Xarelto generated around $6.93 billion in 2020, narrowly surpassing the $6.35 billion it hit in 2019. Bayer took home $4.58 billion of that sum, while Johnson & Johnson collected around $2.35 billion. The 9% sales boost wasn’t enough to outshine chief rival Eliquis, however, which maintained its lead over Xarelto at around $9.17 billion in sales for the year.

Xarelto will celebrate its 10th year on the U.S. market in November, but flatlining prescriptions, mounting competition and Medicare changes have blunted the drug’s trajectory, J&J said last April. Meanwhile, Pfizer and BMS’ Eliquis has continued to dominate the blood thinner field, first taking over warfarin alternatives in terms of market share before ultimately eclipsing warfarin itself.

Bayer and J&J have banked on a broader label to give Xarelto a fighting chance. The FDA in October 2019 approved Xarelto to help prevent blood clots in acutely ill patients without a high risk of bleeding during and after hospitalization. The green light also allowed patients who start the drug in the hospital to continue treatment at home for a recommended duration of 31 to 39 days, J&J said at the time.

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The FDA nod marked Xarelto’s sixth indication that specifically targets blood clots, versus Eliquis’ three.

A few months later, Bayer and J&J’s blood thinner bolstered its case in tough-to-treat artery disease with a trial win in recent post-surgery patients. A mix of Xarelto and aspirin slashed the risk of major limb and cardiovascular events by 15% versus aspirin alone in symptomatic peripheral artery disease patients who’d recently had surgery to unblock the arteries in their legs, data presented last March at the American College of Cardiology scientific sessions showed.

At the 28 week mark, 17.3% of patients on the Xarelto-aspirin combo suffered acute limb ischemia, major amputation for vascular cause, heart attack, ischemic stroke or cardiovascular death, versus 19.9% in the solo aspirin cohort. Patients treated with Xarelto did experience higher rates of bleeding, though there wasn’t a higher rate of severe bleeding, including intracranial or fatal bleeds.

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Still, Pfizer and Bristol Myers Squibb’s anticoagulant wunderkind Eliquis continues to turn up the heat. In August, Eliquis bested vitamin K antagonists—a common family of blood thinners—and Xarelto in reducing the risk of intracranial and gastrointestinal bleeds, as well as general bleeding, according to a subanalysis of French real-world data rolled out at the European Society of Cardiology virtual annual meeting.

The partners pegged the data as part of a growing body of real-world evidence that will help doctors "fill in the gaps" in clinical trial results, Danny Wiederkehr, Pfizer's senior director of global health economics and outcomes research team lead, said. 

Meanwhile, despite a modest uptick in Xarelto sales for the year, ad spending on the drug was down. J&J spent $122 million on national TV media buys for Xarelto with six different commercials airing in 2019, according to data from real-time TV ad tracker iSpot.tv.

But spending plummeted in 2020, with only one commercial running—and even that was halted in June. J&J spent just $21.5 million on TV ads in 2020 and $0 so far in 2021, according to iSpot.

10. Xarelto