Noven Pharmaceuticals, Inc. today provided an update on the status of
its pending Abbreviated New Drug Application (ANDA) seeking approval to
market a lidocaine topical patch 5%. Noven's lidocaine topical patch 5%
is a generic version of Endo Pharmaceuticals' Lidoderm®.
As previously announced, on May 15, 2012, Noven notified Endo and its
partners (Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA) under the
Hatch-Waxman Act that Noven's ANDA had been accepted for review by the
FDA and that it included a paragraph IV certification.
Under the Hatch-Waxman Act, the filing of an ANDA containing a paragraph
IV certification gives a patent holder the right to commence a
pre-approval patent lawsuit in the U.S. federal courts. Accordingly,
earlier today Endo and its partners filed suit against Noven in the U.S.
District Court for the District of Delaware seeking to prevent Noven
from commercializing its lidocaine topical patch 5% prior to the
expiration of certain U.S. patents. Under the Hatch-Waxman Act, the
lawsuit prevents final FDA approval of Noven's ANDA for 30 months from
the date Endo's partners received notice of Noven's ANDA or until the
court declares that the asserted patents are invalid, unenforceable or
not infringed, whichever occurs earlier.
Lidoderm® is indicated for relief of pain associated with
post-herpetic neuralgia. Lidoderm® is a registered trademark
of Hind Health Care, Inc.
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