JERUSALEM--(BUSINESS WIRE)--Feb. 14, 2013--
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that
the U.S. Food and Drug Administration (FDA) has approved its Abbreviated
New Drug Application (ANDA) for the generic version of Shire’s Adderall
XR® Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30 mg capsules for the
treatment of attention deficit hyperactivity disorder. Adderall XR® had
annual sales, including brand and generic sales, of approximately $2
billion in the United States, based on IMS sales data as of December 31,
2012.
Teva currently sells a generic version of Adderall XR® Capsules under a
2006 license and distribution agreement with Shire as part of a
settlement of patent litigation between Shire and Teva’s subsidiary Barr
Pharmaceuticals. Under the terms of the agreement, Teva has the right to
be supplied product by Shire through April 1, 2014.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic
drugs as well as innovative and specialty pharmaceuticals and active
pharmaceutical ingredients. Headquartered in Israel, Teva is the world's
leading generic drug maker, with a global product portfolio of more than
1,000 molecules and a direct presence in about 60 countries. Teva's
branded businesses focus on CNS, oncology, pain, respiratory and women's
health therapeutic areas as well as biologics. Teva currently employs
approximately 46,000 people around the world and reached $20.3 billion
in net revenues in 2012.
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
develop and commercialize additional pharmaceutical products,
competition for our innovative products, especially Copaxone® (including
competition from innovative orally-administered alternatives, as well as
from potential purported generic equivalents), competition for our
generic products (including from other pharmaceutical companies and as a
result of increased governmental pricing pressures), competition for our
specialty pharmaceutical businesses, our ability to achieve expected
results through our innovative R&D efforts, the effectiveness of our
patents and other protections for innovative products, decreasing
opportunities to obtain U.S. market exclusivity for significant new
generic products, our ability to identify, consummate and successfully
integrate acquisitions, the effects of increased leverage as a result of
the acquisition of Cephalon, the extent to which any manufacturing or
quality control problems damage our reputation for high quality
production and require costly remediation, our potential exposure to
product liability claims to the extent not covered by insurance,
increased government scrutiny in both the U.S. and Europe of our
agreements with brand companies, potential liability for sales of
generic products prior to a final resolution of outstanding patent
litigation, including that relating to the generic version of Protonix®,
our exposure to currency fluctuations and restrictions as well as credit
risks, the effects of reforms in healthcare regulation and
pharmaceutical pricing and reimbursement, any failures to comply with
complex Medicare and Medicaid reporting and payment obligations,
governmental investigations into sales and marketing practices
(particularly for our specialty pharmaceutical products), uncertainties
surrounding the legislative and regulatory pathway for the registration
and approval of biotechnology-based products, adverse effects of
political or economical instability, major hostilities or acts of
terrorism on our significant worldwide operations, interruptions in our
supply chain or problems with our information technology systems that
adversely affect our complex manufacturing processes, any failure to
retain key personnel or to attract additional executive and managerial
talent, the impact of continuing consolidation of our distributors and
customers, variations in patent laws that may adversely affect our
ability to manufacture our products in the most efficient manner,
potentially significant impairments of intangible assets and goodwill,
potential increases in tax liabilities, the termination or expiration of
governmental programs or tax benefits, environmental risks and other
factors that are discussed in our Annual Report on Form 20-F for the
year ended December 31, 2011 and in our 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 or revise any forward-looking statement, whether as
a result of new information, future events or otherwise.
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
United States
Kevin
C. Mannix, 215-591-8912
or
Kristen Frank,
215-591-8908
or
Israel
Tomer Amitai, 972-3-926-7656
or
PR:
Israel
Hadar
Vismunski-Weinberg, 972-3-926-7687
or
United States
Denise
Bradley, 215-591-8974