JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today announced that it has filed an abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market the generic version of Novo Nordisk's Victoza® (liraglutide) injection, in the U.S. Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Based on available information, Teva believes it is a "first applicant" to file an ANDA for the generic version of Victoza®; should its ANDA be approved, Teva may be entitled to 180 days of generic market exclusivity.
For the 12 months ending December 31, 2016, Victoza® had total U.S. sales of approximately $3.2 billion, according to IMS Health data.
With nearly 600 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market. Teva has over 300 product registrations pending FDA approval and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in six generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) is a leading global pharmaceutical company that delivers
high-quality, patient-centric healthcare solutions used by millions of
patients every day. Headquartered in Israel, Teva is the world’s largest
generic medicines producer, leveraging its portfolio of more than 1,800
molecules to produce a wide range of generic products in nearly every
therapeutic area. In specialty medicines, Teva has a world-leading
position in innovative treatments for disorders of the central nervous
system, including pain, as well as a strong portfolio of respiratory
products. Teva integrates its generics and specialty capabilities in its
global research and development division to create new ways of
addressing unmet patient needs by combining drug development
capabilities with devices, services and technologies. Teva's net
revenues in 2015 were $19.7 billion. For more information, visit www.tevapharm.com.
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This release contains
forward-looking statements, which 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 specialty
products, especially Copaxone® (which faces competition from
orally-administered alternatives and a generic version); our ability to
realize the anticipated benefits of the acquisition of Allergan plc’s
worldwide generic pharmaceuticals business (“Actavis Generics”), and the
timing of realizing such benefits; our ability to fully and efficiently
integrate Actavis Generics and to achieve the anticipated cost savings,
synergies, business opportunities and growth prospects from the
combination; the fact that we are now dependent to a much larger extent
than previously on our generic pharmaceutical business; our ability to
develop and launch new generic products from the Actavis Generics
pipeline on the anticipated timelines; potential restrictions on our
ability to engage in additional transactions or incur additional
indebtedness as a result of the substantial amount of debt we have
incurred to finance the Actavis Generics acquisition; the fact that we
will have significantly less cash on hand than prior to the consummation
of the Actavis Generics acquisition, which could adversely affect our
ability to grow; our ability to achieve expected results from
investments in our pipeline of specialty and other products; our ability
to identify and successfully bid for suitable acquisition targets or
licensing opportunities, or to consummate and integrate acquisitions;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
increased government scrutiny in both the U.S. and Europe of our patent
settlement agreements; our exposure to currency fluctuations and
restrictions as well as credit risks; the effectiveness of our patents,
confidentiality agreements and other measures to protect the
intellectual property rights of our specialty medicines; the effects of
reforms in healthcare regulation and pharmaceutical pricing,
reimbursement and coverage; competition for our generic products, both
from other pharmaceutical companies and as a result of increased
governmental pricing pressures; governmental investigations into sales
and marketing practices, particularly for our specialty pharmaceutical
products; adverse effects of political or economic instability, major
hostilities or acts of terrorism on our significant worldwide
operations; interruptions in our supply chain or problems with internal
or third-party information technology systems that adversely affect our
complex manufacturing processes; significant disruptions of our
information technology systems or breaches of our data security;
competition for our specialty pharmaceutical businesses from companies
with greater resources and capabilities; the impact of continuing
consolidation of our distributors and customers; decreased opportunities
to obtain U.S. market exclusivity for significant new generic products;
potential liability in the U.S., Europe and other markets for sales of
generic products prior to a final resolution of outstanding patent
litigation; our potential exposure to product liability claims that are
not covered by insurance; any failure to recruit or retain key
personnel, including, in particular, former Actavis Generics personnel
who have transitioned to Teva or to attract additional executive and
managerial talent; any failures to comply with
complex Medicare and Medicaid reporting and payment obligations;
significant impairment charges relating to intangible assets, goodwill
and property, plant and equipment; the effects of increased leverage and
our resulting reliance on access to the capital markets; potentially
significant increases in tax liabilities; the effect on our overall
effective tax rate of the termination or expiration of governmental
programs or tax benefits, or of a change in our business; variations in
patent laws that may adversely affect our ability to manufacture our
products in the most efficient manner; environmental risks; the
possibility of additional adverse consequences arising from our recent
FCPA-related settlement with the U.S. government, including limitations
on our conduct of business in various countries, adverse judgments in
shareholder lawsuits and fines, penalties or other sanctions imposed by
government authorities in other countries; and other factors that are
discussed in our Annual Report on Form 20-F for the year ended December
31, 2015 and in our other filings with the U.S. Securities and Exchange
Commission (the SEC). Forward-looking statements speak only as of the
date on which they are made and we assume no obligation to update or
revise any forward-looking statements or other information, whether as a
result of new information, future events or otherwise.