Dr. Reddy’s Laboratories (NYSE:RDY) has launched Tadalafil Tablets USP, a therapeutic equivalent generic version of Eli Lilly’s Adcirca (tadalafil) tablets in the U.S. market.

According to IQVIA, the Adcirca brand and generic had U.S.sales of ~$490M for the year ended November 2018.

Aquestive Therapeutics (NASDAQ:AQST) has received a CRL from the FDA in response to its marketing application seeking approval for a oral film formulation of tadalafil (AQST-119), the active ingredient in Eli Lilly’s (NYSE:LLY) ED med Cialis and United Therapeutics’ (NASDAQ:UTHR) PAH med Adcirca.

The CRL cited the need for additional data from healthy volunteers which the company believes is “manageable” and should not affect its timing or intent with its partnering efforts.

A generic version of Cialis^® (Eli Lilly) tadalafil tablets (2.5 mg, 5 mg, 10 mg, 20 mg) for the United States market has been annouced by Teva Pharmaceuticals, in a first-to-file launch.

Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and both ED and the signs and symptoms of BPH (ED/BPH). Tadalafil tablets are recommended for use up to 26 weeks when combined with finasteride to initiate BPH treatment.

“We’re proud to offer an affordable treatment option for the estimated 30 million men affected by ED, many of whom will also have symptomatic BPH which is estimated to affect 15 million men in the United States,” said Hafrun Fridriksdottir, EVP and Head of Global R&D for Teva, in a prepared statement.

The most common adverse reactions reported in clinical trials (≥ 2%) for tadalafil were headache, flushing, dyspepsia, nasal congestion, back pain, myalgia, pain in limb, naspharyngitis, upper respiratory tract infection, cough, diarrhea, urinary tract infection, gastroesophageal reflux disease, abdominal pain, gastroenteritis, and hypertension.

Tadalafil tablets are contraindicated in patients using any form of organic nitrate; and in patients with a known serious hypersensitivity to tadalafil. Furthermore, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity.

Brendan O’Grady, EVP and Head of North America Commercial at Teva, noted that the launch of the generic tadalafil tablets builds on the company’s exclusive launch of a generic version of Viagra^® (sildenafil) tablets last year. “We’re committed to ensuring that patients are able to access this medicine,” O’Grady said, in a prepared statement.

Reference

Teva Announces Exclusive First-to-File Launch of a Generic Version of Cialis® in the United States [news release]. Jerusalem; September 27, 2018: Teva Pharmaceuticals. https://seekingalpha.com/pr/17284017-teva-announces-exclusive-first-file-launch-generic-version-cialis-united-states. Accessed September 27, 2018.