6. Baricitinib

Lilly and Incyte are waiting a bit longer than expected for their potential FDA nod on baricitinib, thanks to the agency's request for additional data analyses before making its decision.

Generic name: baricitinib
Company: Eli Lilly and Incyte
Disease: Rheumatoid arthritis
2022 sales estimate: $1.8 billion

As part of a big post-patent-cliff turnaround push, Eli Lilly is working toward a goal of 20 new rollouts between 2014 and 2023. And some analysts, including those at EP Vantage, predict baricitinib—the oral rheumatoid arthritis med the Indianapolis drugmaker developed with Incyte—could be a major one.

Then again, it may not. Baricitinib will follow Pfizer’s Xeljanz into the field, and that’s a product that hasn’t turned out nearly the sales performance that analysts once predicted. Through the first nine months of 2016, it racked up just $649 million in sales, leaving it quite a long way to go to hit analysts’ $1.3 billion rheumatoid arthritis sales prediction for the year.

Baricitinib certainly has a wealth of positive data on its side, and Lilly will push that hard once the med wins approval. Last year, the Indianapolis drugmaker bolstered its data collection with results from a long-term extension study that suggested baricitinib’s previously recorded positive effects could be maintained for at least 48 weeks.

Recently, though, the company learned that it would have to wait a bit longer than expected to see how its prospect fared in the market. In mid-January, the FDA extended its review period for the drug by three months to allow regulators time to review additional data analyses Lilly handed over in response to the agency's information requests. The decision date is now set for mid-April.

Meanwhile, plenty of other RA competitors are making their way through competitors’ pipelines, and they could make Lilly’s job tougher down the line. Three duos—GlaxoSmithKline and Johnson & Johnson, Sanofi and Regeneron, and Gilead Sciences and Galapagos—all have late-stage RA programs in the works. Biosimilars of AbbVie behemoth Humira could complicate the new launch's prospects further, despite baricitinib's head-to-head win against its future rival.

6. Baricitinib