Teva Announces FDA Approval of Generic Adderall XR®

  Teva Announces FDA Approval of Generic Adderall XR®

Business Wire

JERUSALEM -- February 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.

Contact:

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