JERUSALEM--(Business Wire)--
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today the
commercial launch of Fexofenadine Hydrochloride 60 mg and Pseudoephedrine
Hydrochloride 120 mg Extended-Release Tablets, the same as the sanofi-aventis
U.S. allergy treatment Allegra-D 12 Hour (fexofenadine HCl 60 mg and
pseudoephedrine HCl 120 mg) Extended-Release Tablets. Teva's product is an
alternative to the brand product, which had annual sales of approximately $293
million in the United States for the twelve months that ended June 30, 2009,
based on IMS sales data.
As the first company to file an ANDA containing a paragraph IV certification for
this product, Teva has been awarded a 180-day period of marketing exclusivity in
the U.S.
Teva is distributing the product, under a license agreement entered into between
Teva's subsidiary Barr Pharmaceuticals, Inc. and sanofi-aventis U.S. Allegra-D
is a registered trademark of sanofi-aventis U.S.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top
20 pharmaceutical companies in the world and is the world's 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.
Teva`s 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, potential liability for sales of generic products prior to
a final resolution of outstanding patent litigation, including that relating to
the generic versions of Neurontin, Lotrel and Protonix, the current economic
conditions, 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 effects of competition on our innovative
products, especially Copaxone sales, dependence on the effectiveness of our
patents and other protections for innovative products, the impact of
consolidation of our distributors and customers, the impact of pharmaceutical
industry regulation and pending legislation that could affect the pharmaceutical
industry, our ability to achieve expected results though our innovative R&D
efforts, the difficulty of predicting U.S. Food and Drug Administration,
European Medicines Agency and other regulatory authority approvals, the
uncertainty surrounding the legislative and regulatory pathway for the
registration and approval of biotechnology-based products, the regulatory
environment and changes in the health policies and structures of various
countries, supply interruptions or delays that could result from the complex
manufacturing of our products and our global supply chain, our ability to
successfully identify, consummate and integrate acquisitions, the potential
exposure to product liability claims to the extent not covered by insurance, our
exposure to fluctuations in currency, exchange and interest rates, significant
operations worldwide that may be adversely affected by terrorism, political or
economical instability or major hostilities, our ability to enter into patent
litigation settlements and the intensified scrutiny by the U.S. government, the
termination or expiration of governmental programs and tax benefits, impairment
of intangible assets and goodwill, environmental risks, and other factors that
are discussed in this report and in our other filings with the U.S. Securities
and Exchange Commission ("SEC").
Teva Pharmaceutical Industries Ltd.
Elana Holzman, 972 (3) 926-7554
or
Teva North America
Kevin Mannix, 215-591-8912
Copyright Business Wire 2009
