Message #87 From:
NewsBot Date: November 14, 2006 10:34:00 AM
TEVA News Court of Appeals Affirms Teva's Generic Zocor(R) Exclusivity
JERUSALEM, Israel--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that
the U.S. Court of Appeals for the Federal Circuit affirmed a May 1, 2006
decision by the District Court awarding the Company 180-day exclusivity
for its generic version of Merck's Zocor®
(Simvastatin) Tablets.
On June 23, 2006, Teva received final approval from the FDA to market
its Simvastatin Tablets, 5 mg, 10 mg, 20 mg, and 40 mg and immediately
commenced shipment of these products. As the first company to file an
ANDA containing a paragraph IV certification for these strengths, Teva
was eligible to receive 180-day Hatch-Waxman statutory exclusivity to
market these products. Teva's exclusivity will run through Dec. 20, 2006.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among
the top 20 pharmaceutical companies in the world and is the leading
generic pharmaceutical company. The company develops, manufactures and
markets generic and innovative human pharmaceuticals and active
pharmaceutical ingredients, as well as animal health pharmaceutical
products. Over 80 percent of Teva’s sales are
in North America and Europe.
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 Teva’s
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 Teva’s
ability to rapidly integrate IVAX Corporation’s
operations and achieve expected synergies, Teva`s ability to
successfully develop and commercialize additional pharmaceutical
products, the introduction of competing generic products, the impact of
competition from brand-name companies that sell or license their own
brand products under generic trade dress and at generic prices (so
called “authorized generics”)
or seek to delay the introduction of genericproduct, the impact
of consolidation of our distributors and customers, regulatory changes
that may prevent Teva from exploiting exclusivity periods, potential
liability for sales of generic products prior to a final resolution of
outstanding litigation, including that relating to the generic versions
of Allegra®,
Neurontin®
and Zithromax®,
the effects of competition on Copaxone®
sales, including as a result of the reintroduction of Tysabri®
into the market, 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, Teva’s ability to
successfully identify, consummate and integrate acquisitions, potential
exposure to product liability claims, dependence on patent and other
protections for innovative products, significant operations worldwide
that may be adversely affected by terrorism or major hostilities, ,
environmental risks, fluctuations in currency, exchange and interest
rates, operating results and other factors that are discussed in Teva’s
Annual Report on Form20-F and its other filings with the U.S.
Securities and Exchange Commission. Forward-looking statements speak
only as of the date on which they are made and the Company undertakes no
obligation to update publicly or revise any forward-looking statement,
whether as a result of new information, future developments or otherwise.