News: Teva Announces Appellate Court Reverses Generic Risperdal(R) …
Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today
that following a hearing on September 12, 2008, the U.S. Court of
Appeals for the District of Columbia has vacated an April 2008 ruling,
which granted Teva 180-day exclusivity for its Risperidone Tablets,
AB-rated to Janssen’s Risperdal(R) Tablets. As a result of this
decision, the U.S. Food and Drug Administration is no longer enjoined
from approving subsequent Abbreviated New Drug Applications (ANDA).
Teva intends to seek a stay of this decision pending further
appeals.
Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which express
the current beliefs and expectations of management. Such statements
are based on management’s current beliefs and expectations and involve
a number of known and unknown risks and uncertainties that could cause
our future results, performance or achievements to differ
significantly from the results, performance or achievements expressed
or implied by such forward-looking statements. Important factors that
could cause or contribute to such differences include risks relating
to: our ability to successfully develop and commercialize additional
pharmaceutical products, the introduction of competing generic
equivalents, the extent to which we may obtain U.S. market exclusivity
for certain of our new generic products and regulatory changes that
may prevent us from utilizing exclusivity periods, competition from
brand-name companies that are under increased pressure to counter
generic products, or competitors that seek to delay the introduction
of generic products, the impact of consolidation of our distributors
and customers, potential liability for sales of generic products prior
to a final resolution of outstanding patent litigation, including that
relating to the generic versions of Allegra(R) , Neurontin(R),
Lotrel(R) and Protonix(R), the effects of competition on our
innovative products, especially Copaxone(R) sales, the impact of
pharmaceutical industry regulation and pending legislation that could
affect the pharmaceutical industry, the difficulty of predicting U.S.
Food and Drug Administration, European Medicines Agency and other
regulatory authority approvals, the regulatory environment and changes
in the health policies and structures of various countries, our
ability to achieve expected results though our innovative R&D efforts,
our ability to successfully identify, consummate and integrate
acquisitions, including the pending acquisition of Barr
Pharmaceuticals Inc., potential exposure to product liability claims
to the extent not covered by insurance, dependence on the
effectiveness of our patents and other protections for innovative
products, significant operations worldwide that may be adversely
affected by terrorism, political or economical instability or major
hostilities, supply interruptions or delays that could result from the
complex manufacturing of our products and our global supply chain,
environmental risks, fluctuations in currency, exchange and interest
rates, and other factors that are discussed in this report and in our
other filings with the U.S. Securities and Exchange Commission
(”SEC”).
