Teva Announces Exclusive Launch of Generic Pataday® in the United States
June 09 2017 - 8:53AM
Business Wire
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of generic Pataday®1 (olopatadine
hydrochloride ophthalmic solution) 0.2%, in the U.S.
Olopatadine hydrochloride ophthalmic solution 0.2% is a mast
cell stabilizer indicated for the treatment of ocular itching
associated with allergic conjunctivitis.
Teva is committed to strengthening its generics business through
continued investment in complex, high-quality products. With nearly
600 generic medicines available, Teva has the largest portfolio of
FDA-approved generic products on the market 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
product.
“Olopatadine hydrochloride ophthalmic solution 0.2% is an
important treatment for our patients and a key addition to our
generics product portfolio,” said Dipankar Bhattacharjee, Teva’s
President and CEO, Global Generic Medicines. “This launch marks
another successful first-to-file product for Teva, bringing the
only generic version of this product on the market.”
Pataday® had annual sales of approximately $303 million in the
U.S., according to IMS data as of March 2017.
About Olopatadine Hydrochloride Ophthalmic Solution
0.2%
Olopatadine hydrochloride ophthalmic solution 0.2% is indicated
for the treatment of ocular itching associated with allergic
conjunctivitis.
Important Safety Information
Olopatadine hydrochloride ophthalmic solution 0.2% is for
topical ocular use only. It is not for injection or oral use. As
with any eye drop, to prevent contaminating the dropper tip and
solution, care should be taken not to touch the eyelids or
surrounding areas with the dropper tip of the bottle. Patients
should be advised not to wear a contact lens if their eye is red.
Olopatadine hydrochloride ophthalmic solution 0.2% should not be
used to treat contact lens related irritation. The preservative in
olopatadine hydrochloride ophthalmic solution 0.2%, benzalkonium
chloride, may be absorbed by soft contact lenses. Patients who wear
soft contact lenses and whose eyes are not red, should be
instructed to wait at least ten minutes after instilling
olopatadine hydrochloride ophthalmic solution 0.2% before they
insert their contact lenses. The most common adverse reactions
reported (incidence of approximately 10%) were symptoms similar to
cold syndrome and pharyngitis.
For more information, please see accompanying Full Prescribing
Information.
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 approximately 200
million patients in 100 markets 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 the world-leading innovative treatment for
multiple sclerosis as well as late-stage development programs for
other disorders of the central nervous system, including movement
disorders, migraine, pain and neurodegenerative conditions, as well
as a broad portfolio of respiratory products. Teva is leveraging
its generics and specialty capabilities in order to seek new ways
of addressing unmet patient needs by combining drug development
with devices, services and technologies. Teva's net revenues in
2016 were $21.9 billion. For more information, visit
www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding the launch and potential benefits of Teva's generic
version of Pataday®, which are based on management’s current
beliefs and expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements.
Important factors that could cause or contribute to such
differences include risks relating to:
- commercial success of Teva's generic
version of Pataday®;
- our generics medicines business,
including: that we are substantially more dependent on this
business, with its significant attendant risks, following our
acquisition of Allergan plc’s worldwide generic pharmaceuticals
business (“Actavis Generics”); our ability to realize the
anticipated benefits of the acquisition (and any delay in realizing
those benefits) or difficulties in integrating Actavis Generics;
the increase in the number of competitors targeting generic
opportunities and seeking U.S. market exclusivity for generic
versions of significant products; price erosion relating to our
generic products, both from competing products and as a result of
increased governmental pricing pressures; and our ability to take
advantage of high-value biosimilar opportunities;
- our business and operations in general,
including: uncertainties relating to our recent senior management
changes; our ability to develop and commercialize additional
pharmaceutical products; manufacturing or quality control problems,
which may damage our reputation for quality production and require
costly remediation; interruptions in our supply chain; disruptions
of our or third party information technology systems or breaches of
our data security; the failure to recruit or retain key personnel,
including those who joined us as part of the Actavis Generics
acquisition; the restructuring of our manufacturing network,
including potential related labor unrest; the impact of continuing
consolidation of our distributors and customers; variations in
patent laws that may adversely affect our ability to manufacture
our products; adverse effects of political or economic instability,
major hostilities or terrorism on our significant worldwide
operations; and our ability to successfully bid for suitable
acquisition targets or licensing opportunities, or to consummate
and integrate acquisitions; and
- compliance, regulatory and litigation
matters, including: costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; potential additional adverse
consequences following our resolution with the U.S. government of
our FCPA investigation; governmental investigations into sales and
marketing practices; potential liability for sales of generic
products prior to a final resolution of outstanding patent
litigation; product liability claims; increased government scrutiny
of our patent settlement agreements; failure to comply with
complex Medicare and Medicaid reporting and payment
obligations; and environmental risks.
and other factors discussed in our Annual Report on Form 20-F
for the year ended December 31, 2016 (“Annual Report”)
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 contained herein, whether as a result of new
information, future events or otherwise. You are cautioned not to
rely on these forward-looking statements. You are advised to
consult any additional disclosures we make in our reports to
the SEC on Form 6-K, as well as the cautionary discussion of
risks and uncertainties under “Risk Factors” in our Annual Report.
These are factors that we believe could cause our actual results to
differ materially from expected results. Other factors besides
those listed could also materially and adversely affect us. This
discussion is provided as permitted by the Private Securities
Litigation Reform Act of 1995.
1 Pataday® is a registered trademark of Alcon Laboratories,
Inc., a Novartis company.
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version on businesswire.com: http://www.businesswire.com/news/home/20170609005372/en/
IR Contacts:United StatesKevin C. Mannix,
215-591-8912Ran Meir, 215-591-3033orIsraelTomer
Amitai, 972 (3) 926-7656orPR Contacts:IsraelIris Beck
Codner, 972 (3) 926-7687orUnited StatesDenise Bradley,
215-591-8974Nancy Leone, 215-284-0213
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