News: Teva Announces Tentative Approval of Generic Prevacid(R) …
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today
that the U.S. Food and Drug Administration has granted tentative
approval for the Company’s Abbreviated New Drug Application (ANDA) to
market its generic version of TAP Pharmaceutical’s gastric-acid pump
inhibitor, Prevacid(R) (Lansoprazole) Delayed-release Capsules, 15 mg
and 30 mg. The brand product had annual sales of approximately $3.4
billion in the United States for the twelve months ended September 30,
2007, based on IMS sales data.
Teva is currently in patent litigation concerning this product in
the U.S. District Court for the District of Delaware involving Teva’s
paragraph IV certification to U.S. Patent Nos. 4,628,098 and
5,045,321. A trial was held in November, at the end of which the Court
indicated it anticipates it will issue a decision before the June 7,
2008 expiration of the mandatory 30-month stay of FDA approval
associated with the patent litigation.
About Teva
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. 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: 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)
Famvir(R) and Protonix(R), Teva’s ability to successfully develop and
commercialize additional pharmaceutical products, the introduction of
competing generic equivalents, the extent to which Teva may obtain
U.S. market exclusivity for certain of its new generic products and
regulatory changes that may prevent Teva 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, 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, whether and
when the proposed acquisition of CoGenesys will be consummated, Teva’s
ability to rapidly integrate CoGenesys’s operations with its own
operations, 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, Teva’s ability to
successfully identify, consummate and integrate acquisitions,
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
