Generic Version of Adcirca to be Launched in US Under Brand Name ALYQ for PAH

Alberto Molano, PhD avatar

by Alberto Molano, PhD |

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Teva Pharmaceutical Industries announced the launch of a generic version of Adcirca (tadalafil) under the brand name ALYQ for the treatment of pulmonary arterial hypertension (PAH) in the United States.

PAH is characterized by the narrowing of blood vessels (vasoconstriction) in the lungs, which leads to high blood pressure and an inability to effectively transport oxygen throughout the body.

Adcirca works by inhibiting an enzyme called phosphodiesterase type 5, which is responsible for the degradation of a small molecule called cyclic guanosine monophosphate. This molecule relaxes pulmonary vascular smooth muscle cells, so inhibiting the enzyme that degrades it results in pulmonary vessel vasodilation.

Adcirca, marketed by Eli Lilly in Europe and United Therapeutics in the U.S., is a therapy approved to reduce the symptoms and improve the exercise ability of PAH patients classified as WHO group 1, which include those with idiopathic, heritable, drug- and toxin-induced PAH, and PAH associated with other systemic diseases such as scleroderma, systemic lupus erythematosus, mixed connective tissue disease, and rheumatoid arthritis.

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Adcirca has proven effective in PAH patients with New York Heart Association functional class II (mild) and III (moderate) symptoms. This functional classification is used to rate how sick patients are.

As U.S. patents for Adcirca (held by Eli Lilly) expire, Teva can apply to the U.S. Food and Drug Administration for permission to develop and sell a generic version of the medication. Without the costs incurred in the development process, the company can afford to make and sell the therapy at cheaper prices.

“This launch is an important addition to our portfolio of generic medicines that treat complex conditions and we’re proud to offer an affordable treatment option for this rare disease,” Brendan O’Grady, head of North America Commercial at Teva, said in a press release.

Teva has a strong commitment to provide patients with generic medications. Currently, according to the company, “one in seven of the 3.86 billion generic prescriptions written in the United States is filled with a Teva product.”

The company expects the launch of ALYQ to further expand their generic portfolio. ALYQ will be available as a 20 mg pill in bottles of 60 oral tablets.

A Conversation With Rare Disease Advocates