Teva's Generic Evista Approved In The U.S.

Teva announced that its generic equivalent to Evista (raloxifene) 60 mg tablets has been approved in the U.S. The approval makes Teva’s generic version eligible for 180 days of marketing exclusivity.

Evista 60 mg tablet is originally marketed by Eli Lilly and Co. The drug has sales of an estimated $824 million per year in the U.S. Its looming patent expiration is expected to add to the pressure of competition from generics, prompting company CFO Derica Rice to call 2014 the most financially challenging year for Lilly’s patent cliff. Evista’s patent expiration is among the top ten for this year, ranking among AstraZeneca’s Nexium, Pfizer’s Cymbalta, and Novartis’ Sandostatin LAR. Lilly had already borne out patent expiration of Cymbalta (duloxitine HCI) which hit global sales of over four billion dollars in 2011.

The drug is an estrogen agonist/antagonist, called a selective estrogen receptor modulator (SERM) belonging to the benzothiophene class of compounds. Evista is primarily indicated in the treatment and prevention of osteoporosis in postmenopausal women.

Osteoporosis is a recognized and well-defined disease that affects more than 75 million people in the U.S., Europe, and Japan. More than 8.9 million fractures per year occur due to osteoporosis worldwide, according to the World Health Organization. The disease also ranks high among diseases that cause people to become bedridden with life-threatening complications, aside from being a major cause of fractures.

Raloxifene is also indicated in the reduction of risk of invasive breast cancer in postmenopausal women with osteoporosis and reduction of risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer.

The company was the first to file among generic drug makers. The product launch of Teva’s generic Evista is one of the most critical for the company, analysts say. Teva said it will begin shipment of the product within the next month.