Table of Contents
PARSIPPANY, N.J. — Actavis Inc. has released a generic version of Lidoderm (lidocaine topical patch 5%).
The company said Monday that it launched the generic product as part of an exclusive settlement agreement with Endo Pharmaceuticals Inc. and Teikoku Seiyaku Co. Ltd.
Actavis said it has begun shipping the Lidoderm generic product and believes that, under Hatch Waxman rules, the company is entitled to 180 days of marketing exclusivity.
"Thanks to this settlement agreement, consumers across the country are today benefitting from generic competition on Lidoderm more than two years before the product’s patents expire," stated Paul Bisaro, president and chief executive officer of Actavis. "We are pleased to be able to provide patients with this more affordable treatment option while offering yet another reminder of how patent settlements have saved and continue to save consumers billions of dollars and ensure the more-timely introduction of generic competition."
A local anesthetic, Lidoderm is indicated to relieve post-shingles pain. The product had sales of about $1.4 billion for the 12 months ended May 31, according to IMS Health figures cited by Actavis.
The company added that the product launch also marks the culmination of a $44 million expansion of a state-of-the-art pharmaceutical research, development and manufacturing facility for transdermal and topical gel products in Salt Lake City.
"Initiated in 2011, the expansion involved retrofitting approximately 20,000 square feet of existing space, constructing approximately 17,000 square feet of new manufacturing space and adding approximately 300 new jobs," according to Bisaro. "These efforts ensured that we could maximize the talents and capabilities of our Salt Lake team in driving not only this important launch but also planned future pipeline launches."
