Noven Confirms Filing of Abbreviated New Drug Application for Generic
Version of Exelon® (Rivastigmine Transdermal System)
Paragraph IV Litigation Initiated by Patent Holders
MIAMI & NEW YORK -- April 3, 2013
Noven Pharmaceuticals, Inc. today confirmed that it has filed an Abbreviated
New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA)
seeking approval to market its rivastigmine transdermal system in 4.6 mg/24
hours and 9.5 mg/24 hours dosage strengths. Noven’s product, if approved,
would be a generic version of Novartis Pharmaceuticals Corporation’s Exelon^®
On February 18, 2013, pursuant to the Hatch-Waxman Act, Noven provided its
Paragraph IV Certification Notice Letter advising Novartis and LTS Lohmann
Therapie-Systeme AG (holders of certain patents asserted to cover the Exelon^®
product) that Noven’s ANDA had been accepted for review by the FDA.
Under the Hatch-Waxman Act, the filing of an ANDA containing a Paragraph IV
Certification gives the patent or NDA holder the right to commence a
pre-approval patent lawsuit in the U.S. federal courts. Earlier today,
Novartis (and affiliates) and LTS Lohmann filed suit against Noven (and
affiliates) in the U.S. District Court for the District of Delaware seeking to
prevent Noven from commercializing its rivastigmine transdermal system prior
to the expiration of the relevant U.S. patents. Under the Hatch-Waxman Act,
this lawsuit prevents final FDA approval of Noven’s ANDA for 30 months from
the date Novartis and LTS Lohmann received Noven’s notice letter, or until the
court declares that the asserted patents are invalid, unenforceable or not
infringed, whichever occurs earlier.
Exelon^® (rivastigmine transdermal system) is indicated for the treatment of
mild to moderate dementia of the Alzheimer’s type, and for the treatment of
mild to moderate dementia associated with Parkinson’s disease. Exelon^® is a
registered trademark of Novartis AG Corporation.
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in
the research, development, manufacturing, marketing and sale of prescription
pharmaceutical products. Noven is committed to developing and offering
products and technologies that meaningfully benefit patients, its customers
and its industry partners. Noven is a stand-alone operating subsidiary of
Japan-based Hisamitsu Pharmaceutical Co., Inc., and serves as Hisamitsu’s U.S.
growth platform in prescription pharmaceuticals. For more information about
Noven, visit www.noven.com. For information about Hisamitsu, visit
Noven Pharmaceuticals, Inc.
Joseph C. Jones, 305-253-1916
Vice President – Corporate Affairs
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