The U.S. Food and Drug Administration gave Mylan final approval for its abbreviated new drug application for tadalafil, along with 180 days of marketing exclusivity for the product.
Mylan’s new product, like Adcirca, is indicated for the improvement of exercise capacity in PAH patients.
Tadalafil is an inhibitor of PDE5 (phosphodiesterase-5), which is a factor produced in the lungs that breaks down a molecule called cyclic guanosine monophosphate (GMP). Cyclic GMP causes blood vessels to relax and widen, a process called vasodilation.
By decreasing the activity of PDE5, tadalafil indirectly increases the levels of cyclic GMP, which leads to vasodilation. This, in turn, reduces pulmonary blood pressure and improves heart function, allowing patients to become more active.
Tadalafil has been shown to improve exercise ability and delay clinical progression in PAH patients. Adcirca was approved for the treatment of PAH by the FDA in 2009.
Generic medications are allowed for sale after the patent on the original medication expires. They are replicas of brand-name medications that have the same dosage, indications, side effects, method of administration, risk, safety, and strength as the original, in this case Adcirca.
“Mylan has a strong history of leading the way in creating important access to generic medicines, and we’re excited to continue that tradition by offering the first generic to Adcirca Tablets,” Heather Bresch, CEO of Mylan, said in a press release. “Mylan offers more than 650 products in the U.S., and the addition of Tadalafil Tablets strengthens our cardiovascular portfolio and commitment to these patients.”
According to IQVIA, an organization that helps pharmaceutical and biotech companies innovate and maximize opportunities, the sales for 20 mg tadalafil tablets in the U.S. over a 12-month period — between June 1, 2017 and May 31, 2018 — were approximately $510 million.
Now Mylan’s generic tadalafil tablets will offer a more affordable alternative for PAH patients.
According to the FDA, “increasing the availability of generic drugs helps to create competition in the marketplace, which then helps to make treatment more affordable and increases access to healthcare for more patients.”