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news.Watson has confirmed that its subsidiary, Watson Laboratories has filed an Abbreviated New Drug Application (ANDA) with the FDA, seeking approval to market its lidocaine topical patch 5% prior to the expiration of US Patent No. 5827529. The lidocaine topical patch 5% is a generic version of Endo's Lidoderm.
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On January 15, 2010, pursuant to the Hatch-Waxman Act, Watson notified Endo’s partners, Teikoku Seiyaku Co and Teikoku Pharma USA, that its ANDA requesting approval from the FDA for a generic version of Lidoderm contained a paragraph IV certification asserting that the Lidoderm patent is invalid, unenforceable and/or not infringed.
Lidoderm is indicated for relief of pain associated with post-herpetic neuralgia. Lidoderm is contraindicated in patients with a history of sensitivity to local anesthetics (amide type) or any product component.
Watson Pharmaceuticals is a global specialty pharmaceutical company engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and women’s health.