Sandoz launches donepezil HCL tablets, a generic version of Aricept®
Princeton, New Jersey; June 1, 2011 - Sandoz today announced the US Food and Drug Administration (FDA) approval and US launch of donepezil hydrochloride (HCL) film-coated tablets and donepezil HCL orally-disintegrating tablets (ODT). Donepezil HCL film-coated tablets and donepezil HCL ODT are generic equivalents to Aricept® and Aricept® ODT, respectively.
Donepezil HCL film-coated tablets and donepezil HCL ODT are indicated for the treatment of dementia of the Alzheimer's type, demonstrating efficacy in patients with mild, moderate, and severe Alzheimer's disease. An estimated 5.4 million Americans have Alzheimer's disease, equivalent to one out of every eight older Americans .
According to IMS Health, US sales for donepezil HCL film-coated tablets and donepezil HCL ODT were approximately USD 2.3 billion for the 12 months ending March 2011. Sandoz is marketing both donepezil HCL film-coated and donepezil HCL ODT in 5mg and 10mg strengths. These dosing regimens are identical to that of Aricept® and Aricept® ODT.
The foregoing release contains forward-looking statements that can be identified by terminology such as
"launches," "launch," or similar expressions, or by express or implied discussions regarding potential
future revenues from donepezil. You should not place undue reliance on these statements. Such forward-
looking statements reflect the current views of the Company regarding future events, and involve known
and unknown risks, uncertainties and other factors that may cause actual results to be materially different
from any future results, performance or achievements expressed or implied by such statements. There
can be no guarantee that donepezil will achieve any particular levels of revenue in the future. In particular,
management's expectations could be affected by, among other things, unexpected regulatory actions or
delays or government regulation generally, including potential FDA approval of additional versions of
donepezil; competition in general; government, industry and general public pricing pressures; unexpected
patent litigation outcomes; unexpected manufacturing difficulties; the impact that the foregoing factors
could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the
Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form
20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary
materially from those anticipated, believed, estimated or expected. Novartis is providing the information in
this press release as of this date and does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new information, future events or otherwise.
Sandoz, a Division of the Novartis group, is a global leader in the field of generic pharmaceuticals, offering
a wide array of high-quality, affordable products that are no longer protected by valid and enforceable
third-party patents. Sandoz has a portfolio of approximately 1000 compounds and sells its products in
about 130 countries. Key product groups include cardiovascular medicines, anti-infectives, treatments for
central nervous system and alimentary tract disorders, oncology and respiratory therapies, as well as
medications for blood and blood forming organ disorders. Sandoz develops, produces and markets these
medicines along with pharmaceutical and biotechnological active substances. In addition to strong organic
growth in recent years, Sandoz has made a series of acquisitions including Lek (Slovenia), Sabex
(Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), and Oriel Therapeutics (US). In
2010, Sandoz employed more than 23,000 people (full-time equivalents) worldwide and achieved net
sales of USD 8.5 billion for the full year.
Alzheimer's Association. 2011 Alzheimer's Disease Facts and Figures. Available from:
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Sandoz US Communications:
Sandoz Global Communications:
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Aricept® and Aricept® ODT are registered trademarks of Eisai Co., Ltd. and Pfizer Inc.