FDA approves first generic version of Lidoderm

FDA has approved Watson’s lidocaine topical patch 5%, the first generic version of Lidoderm (Endo) for the relief of pain associated with post-herpetic neuralgia.

Watson is expected to launch the product September 2013 pursuant with its settlement agreement with Endo Pharmaceuticals Inc. and believes that under Hatch Waxman rules, it will be entitled to 180 days of marketing exclusivity.

On May 29, 2012, Watson entered into an agreement with Endo Pharmaceuticals Inc. and Teikoku Seiyaku Co., Ltd to settle all outstanding patent litigation related to Watson’s generic version of Lidoderm. The agreement allows Watson to launch its lidocaine topical patch 5% product on September 15, 2013.

According to a statement from Endo: "We are disappointed in FDA's decision to deny the citizen petition and approve a generic version of Lidoderm. The company believes that the approval of a generic version of Lidoderm without requiring clinical end point studies is inadequate to establish the safety and efficacy of this locally-acting topical medication. The company anticipated the possibility of generic competition for Lidoderm in September of 2013 pursuant to its settlement agreement with Watson Pharmaceuticals and has been proactively preparing for the event."

For the 12 months ending June 30, 2012, Lidoderm had total US sales of approximately $1.2 billion, according to IMS Health data.

"If the generic lidocaine patch product is priced competitively with Lidoderm, it will be well received," said Formulary advisor James M. Wooten, PharmD, associate professor, department of medicine, section of clinical pharmacology, University of Missouri-Kansas City. "The lidocaine patch can be an effective treatment for post-herpetic neuralgia, which can be quite painful. Shingles - infection with the herpes zoster virus - can be a common problem in the elderly."