Mylan announces the launch of the first generic version of Adcirca
Today, Mylan Pharmaceuticals (MYL) announced the launch of tadalafil tablets USP (20 mg) in the United States. Tadalafil is intended for the treatment of PAH (pulmonary arterial hypertension) for the improvement of exercise ability. The drug is the first generic version of Eli Lilly’s (LLY) Adcirca (tadalafil) approved by the FDA.
United Therapeutics (UTHR) has the exclusive commercialization rights to Adcirca in the United States. Eli Lilly sells tadalafil as Cialis for the treatment of erectile dysfunction. Mylan received final FDA approval for its ANDA (Abbreviated New Drug Application), and the FDA awarded a 180-day market exclusivity period to the company for the product.
According to IQVIA data, tadalafil tablets USP 20 mg generated sales of ~$510.0 million in the United States for the year ended May 31. Adcirca lost its market exclusivity in May.
According to Heather Bresch, CEO of Mylan, “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.”
Bresch added, “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.”
MYL stock moves up on positive news
Today, Mylan stock is trending higher and was up over 1.0% in afternoon trading. Eli Lilly (LLY) stock is up ~0.3% while United Therapeutics stock is down ~2.0%.
RBC Capital raised its recommendation on Mylan stock today from “sector perform” to “outperform” and increased its 12-month target price on the stock from $42 to $51. You can read more about this event in RBC Is Bullish on Generic Pharma: Upgrades MYL, AMRX, ENDO, AKRX.
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