Teva Pharmaceutical Industries (NYSE and TASE: TEVA) today
announced availability of the FDA-approved generic version of
EpiPen Jr®1 (epinephrine injection, USP) Auto-Injector, 0.15 mg, in
the U.S. The product is available in most retail pharmacies, and
the Wholesale Acquisition Cost is $3002 for a 2-pack.
”We’re pleased to provide access to Epinephrine Injection
(Auto-Injector) in two strengths for patients who may experience
life-threatening allergic emergencies,” said Brendan O’Grady, EVP
and Head of North America Commercial. “We will continue working to
ensure availability of both strengths in the US and plan to
accelerate production to meet the urgent need for this
medicine.”
With nearly 500 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 US. Currently, one in nine
generic prescriptions dispensed in the US is filled with a Teva
product.
Teva’s generic equivalent of EpiPen® and EpiPen Jr® utilize the
Antares Pharma (NASDAQ: ATRS) VIBEX® device. Antares and Teva have
an exclusive License, Development and Supply Agreement for
epinephrine auto injector products that Teva markets in the
U.S.
About Epinephrine Injection
Epinephrine Injection (Auto-Injector) is a prescription medicine
in a disposable, prefilled automatic injection device
(auto-injector) used to treat life-threatening, allergic
emergencies including anaphylaxis in people who are at risk for or
have a history of serious allergic emergencies. Each device
contains a single dose of epinephrine.
Epinephrine Injection (Auto-Injector) is for immediate self (or
caregiver) administration and does not take the place of emergency
medical care. You should get emergency help right away after using
Epinephrine Injection (Auto-Injector).
Epinephrine Injection, 0.3 mg (Auto-Injector) is for patients
who weigh 66 pounds or more (30 kilograms or more). Epinephrine
Injection, 0.15 mg (Auto-Injector) is for patients who weigh about
33 to 66 pounds (15 to 30 kilograms). It is not known if
Epinephrine Injection (Auto-Injector) is safe and effective in
children who weigh less than 33 pounds (15 kilograms).
IMPORTANT SAFETY INFORMATION
Anaphylaxis can be life-threatening, can happen within minutes,
and can be caused by stinging and biting insects, allergy
injections, foods, medicines, exercise, or unknown causes. Use
Epinephrine Injection (Auto-Injector) right away when you have an
allergic emergency (anaphylaxis). Get emergency medical help
right away. You may need further medical attention. You may
need to use a second Epinephrine Injection (Auto-Injector) if
symptoms continue or recur. Only a healthcare provider should give
additional doses of epinephrine if you need more than 2 injections
for a single anaphylaxis episode.
Epinephrine Injection (Auto-Injector) should only be
injected into the middle of your outer thigh (upper leg) through
clothing if necessary. Do not inject the Epinephrine
Injection (Auto-Injector) into your: veins, buttocks, fingers,
toes, hands, or feet. If you inject a young child with Epinephrine
Injection (Auto-Injector), hold their leg firmly in place before
and during the injection to prevent injuries. If you accidentally
inject Epinephrine Injection (Auto-Injector) into any other part of
your body, go to the nearest emergency room right away. Tell the
healthcare provider where on your body you received the accidental
injection.
Rarely, patients who have used Epinephrine Injection
(Auto-Injector) may develop infections at the injection site within
a few days of an injection. Some of these infections can be
serious. Call your healthcare provider right away if you have any
of the following at an injection site: redness that does not go
away, swelling, tenderness, or the area feels warm to the
touch.
If you have certain medical conditions, or take certain
medicines, your condition may get worse or you may have longer
lasting side effects when you use your Epinephrine Injection
(Auto-Injector). Tell your healthcare provider about all known
allergies, all your medical conditions and all the medicines you
take, especially if you take asthma medicines.
Common side effects of Epinephrine Injection (Auto-Injector)
include: fast, irregular or “pounding” heartbeat; sweating;
headache; weakness; shakiness; paleness; feelings of over
excitement, nervousness or anxiety; dizziness; nausea or vomiting;
and breathing problems. These side effects may go away with rest.
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away.
These are not all the possible side effects of Epinephrine
Injection (Auto-Injector). For more information, ask your
healthcare provider or pharmacist. Call your healthcare provider
for medical advice about side effects. You may report side effects
to FDA at 1-800-FDA-1088.
For more information, please see accompanying Full Prescribing
Information.
A copy may be requested from Teva US Medical Information at
888-TEVA-USA (888-838-2872) or druginfo@tevapharm.com, or Teva’s
Public Relations or Investor Relations contacts.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 3,500
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day, and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. Learn more at 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 Teva’s generic version of the EpiPen®, 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:
- the commercial success, including availability of sufficient
supply, of Teva’s generic version of the EpiPen® and EpiPen
Jr®;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; competition for our specialty products, especially
COPAXONE®, our leading medicine, which faces competition from
existing and potential additional generic versions and
orally-administered alternatives; the uncertainty of commercial
success of AJOVY® or AUSTEDO®; competition from companies with
greater resources and capabilities; efforts of pharmaceutical
companies to limit the use of generics, including through
legislation and regulations; consolidation of our customer base and
commercial alliances among our customers; 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 products, both from
competing products and increased regulation; delays in launches of
new products and our ability to achieve expected results from
investments in our product pipeline; our ability to take advantage
of high-value opportunities; the difficulty and expense of
obtaining licenses to proprietary technologies; and the
effectiveness of our patents and other measures to protect our
intellectual property rights
- our substantial indebtedness, which may limit our ability to
incur additional indebtedness, engage in additional transactions or
make new investments, may result in a further downgrade of our
credit ratings; and our inability to raise debt or borrow funds in
amounts or on terms that are favorable to us;
- our business and operations in general, including: failure to
effectively execute our restructuring plan announced in December
2017; uncertainties related to, and failure to achieve, the
potential benefits and success of our senior management team and
organizational structure; harm to our pipeline of future products
due to the ongoing review of our R&D programs; our ability to
develop and commercialize additional pharmaceutical products;
potential additional adverse consequences following our resolution
with the U.S. government of our FCPA investigation; compliance with
sanctions and other trade control laws; 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; variations in intellectual
property laws that may adversely affect our ability to manufacture
our products; challenges associated with conducting business
globally, including adverse effects of political or economic
instability, major hostilities or terrorism; significant sales to a
limited number of customers in our U.S. market; our ability to
successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions;
implementation of a new enterprise resource planning system that,
if deficient, could materially and adversely affect our operations
and/or the effectiveness of our internal controls; and our
prospects and opportunities for growth if we sell assets;
- 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; increased legal and regulatory action in connection
with public concern over the abuse of opioid medications in the
U.S.; governmental investigations into selling and marketing
practices; potential liability for patent infringement; 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;
- other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
significant increases in tax liabilities; and 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;
and other factors discussed in our Quarterly Reports on Form
10-Q for the first and second quarter of 2019 and in our Annual
Report on Form 10-K for the year ended December 31, 2018, including
in the sections captioned "Risk Factors” and “Forward Looking
Statements.” 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 put undue reliance on
these forward-looking statements.
1 EpiPen® and EpiPen Jr® are registered trademarks of Mylan®
Inc.
2 Teva does not set the price that a pharmacy charges for a
particular drug and does not have visibility or control into the
price of the drug in the marketplace.
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IR Contacts United States Kevin C. Mannix (215) 591-8912
Ran Meir 972 (3) 926-7516
PR Contacts United States Kelley Dougherty (973)
658-0237 Israel Yonatan Beker 972 (54) 888 5898
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