Company: Novo Nordisk
Disease: Growth hormone-related disorders
2016 U.S. sales: $642.5 million
U.S. patent expiration date: December 26
Novo Nordisk’s only product on the list of top 2017 U.S. patent losses is Norditropin SimpleXx, a growth hormone formulation set to lose exclusivity at the end of the year. Luckily for the Danish drugmaker, however, it's not likely to get generic competition immediately, thanks to its proprietary injection pen.
Norditropin SimpleXx was the first liquid formulation of Norditropin, a commonly used generic growth hormone, somatropin, previously available only in powder form for reconstitution. A Novo spokesperson confirmed that Norditropin SimpleXx's formulation patent will expire December 26.
Likely because of the patent-protected pen—like Advair's Diskus inhaler and Mylan's EpiPen injector before it—it's poised to hold on to the bulk of its 2016 sales haul in the coming years even after its late-December patent loss, according to EvaluatePharma's calculations. Its sales will slide to $605 million in 2018 from $642.5 million in 2016, and then slowly fall to $586 million by 2022, the analysts estimate.
Norditropin treats growth failure in children if they have a growth hormone deficiency, Turner syndrome, reduced kidney function or are short and were born small for gestational age.
Aside from the U.S., Novo loses its Norditropin SimpleXx patents in Germany, China and Japan this year, according to its 2015 annual report. Novo is the world’s market leader in growth hormones with Norditropin, the report states, with a share of 35%. The company first introduced the therapy in the 1980s.