Teva Reaches Settlement in ProAir® HFA Patent Case
20 Juin 2014 - 2:59PM
Business Wire
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced that
it has reached a settlement with Perrigo Pharmaceutical Co. and
Catalent Pharma Solutions LLC with respect to four patents for
Teva’s ProAir® HFA (albuterol sulfate) Inhalation Aerosol product.
This settlement provides a license to Perrigo and Catalent to sell
limited units of Perrigo’s generic version of the product for an
initial period beginning Dec. 19, 2016 and lasting until June 2018,
when the limits will no longer apply.
This settlement dismisses pending litigation in the U.S.
District Court for the District of Delaware in which Teva filed
suit against Perrigo and Catalent in response to a notice of the
filing of an ANDA containing a paragraph (IV) certification
directed against four (4) of the five (5) patents listed in the
Orange Book for ProAir® HFA (U.S. Patent 7,105,152, which expires
September 12, 2023; 7,566,445, which expires June 4, 2017;
6,446,627, which expires December 18, 2017; and 8,132,712, which
expires September 7, 2028.) Additional terms of the settlement are
agreed by the parties to remain undisclosed.
There are currently no additional challenges to the IP for
ProAir® HFA and no further litigation pending. Teva will continue
to vigorously defend its intellectual property rights relating to
its products.
About ProAir® HFA
ProAir® HFA is indicated in patients 4 years of age and older
for the treatment or prevention of bronchospasm with reversible
obstructive airway disease and for the prevention of
exercise-induced bronchospasm.
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 approximately 60 countries. Teva's
Specialty Medicines businesses focus on CNS, respiratory, oncology,
pain, and women's health therapeutic areas as well as biologics.
Teva currently employs approximately 45,000 people around the world
and reached $20.3 billion in net revenues in 2013.
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 innovative
products, especially COPAXONE® (including competition from
orally-administered alternatives, as well as from potential
purported generic equivalents); the possibility of material fines,
penalties and other sanctions and other adverse consequences
arising out of our ongoing FCPA investigations and related matters;
our ability to achieve expected results from the research and
development efforts invested in our pipeline of specialty and other
products; our ability to reduce operating expenses to the extent
and during the timeframe intended by our cost reduction program;
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; our potential exposure
to product liability claims that are not covered by insurance;
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; governmental investigations
into sales and marketing practices, particularly for our specialty
pharmaceutical products; uncertainties related to our recent
management changes; the effects of increased leverage and our
resulting reliance on access to the capital markets; any failure to
recruit or retain key personnel, or to attract additional executive
and managerial talent; 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 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 generic
products, both from other pharmaceutical companies and as a result
of increased governmental pricing pressures; competition for our
specialty pharmaceutical businesses from companies with greater
resources and capabilities; 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; any failures to comply with complex Medicare and
Medicaid reporting and payment obligations; the impact of
continuing consolidation of our distributors and customers;
significant impairment charges relating to intangible assets and
goodwill; 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; and other factors that are
discussed in our Annual Report on Form 20-F for the year ended
December 31, 2013 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 we assume no obligation to
update or revise any forward-looking statement, whether as a result
of new information, future events or otherwise.
Teva Pharmaceutical Industries Ltd.IR:United StatesKevin C.
Mannix, 215-591-8912Ran Meir,
215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley, 215-591-8974Nancy
Leone, (215) 284-0213
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