BRIDGEWATER, N.J. — Amneal Pharmaceuticals LLC has launched diclofenac sodium topical gel 1%, a pain reliever for osteoarthritis, in the United States.
Amneal said its product, available in a 100-gram tube, is a first-to-market generic version of Voltaren Gel from Endo International plc and has begun shipping through wholesalers and directly to the trade.
“We are very pleased to be the first generic supplier of diclofenac sodium topical gel,” stated Chirag Patel, co-chairman and co-chief executive officer of Amneal, which recently received final approval for its generic product from the Food and Drug Administration. “This significant milestone continues to demonstrate our ability to bring complex dosage forms to our customers and patients, and generate savings to the health care system.”
A nonsteroidal anti-inflammatory drug (NSAID), diclofenac sodium topical gel is indicated for the relief of joint pain from osteoarthritis in the knees, ankles, feet, elbows, wrists, and hands.
U.S. sales of diclofenac sodium topical gel totaled approximately $413 million for the 12 months ending in January, according to IMS Health date reported by Amneal.
Earlier this week, Endo issued a statement and released a document regarding the expected FDA approval of a Voltaren Gel generic.
“Endo is evaluating a number of options regarding Voltaren Gel focused on evolving its branded product strategy, determining the timing of a potential authorized generic product launch and maximizing overall value,” Endo stated. “The company will provide additional detail regarding the potential financial impact of a generic entrant for Voltaren Gel no later than its first quarter 2016 earnings presentation in early May 2016.”
In December, Endo announced that it received an extension of its exclusive U.S. marketing rights for Voltaren Gel and was granted extended U.S. rights for the product’s authorized generic, if the company opted to launch it commercially in the future. Through an indirect subsidiary, Endo entered into a licensing agreement with Sandoz Inc. and Novartis AG through June 30, 2023, for Voltaren Gel.