Teva Announces the U.S. Launch of the First Generic Version of THIOLA® (tiopronin) tablets
May 17 2021 - 1:03PM
Business Wire
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced its launch
of the first available generic version, in the U.S., of THIOLA®
(tiopronin) tablets, indicated, in combination with high fluid
intake, alkali, and diet modification, for the prevention of
cystine (kidney) stone formation in adults and pediatric patients 9
years of age and older with severe homozygous cystinuria, who are
not responsive to these measures alone.
“Teva is pleased to provide patients with first-to-market access
to a generic version of THIOLA® (tiopronin) tablets for the
prevention of kidney stones, and who are unresponsive to treatment
with high fluid intake, alkali, and diet modification,” said
Christine Baeder, SVP, Chief Operating Officer US Generics, Teva
USA.
With nearly 550 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
approximately 100 pending first-to-files in the U.S. Currently, 1
in 11 generic prescriptions dispensed in the U.S. is filled with a
Teva generic product.
About Tiopronin Tablets
Tiopronin tablets is a prescription medicine used in combination
with high fluid intake, alkali (low acid), and dietary changes to
help prevent the formation of one type (cystine) of kidney stone in
certain adult and pediatric patients 9 years of age or older who do
not respond to these measures alone.
IMPORTANT SAFETY INFORMATION
Who should not take tiopronin tablets? Tiopronin tablets
should not be taken if you are allergic to tiopronin or any of the
ingredients in tiopronin tablets.
What should I tell my doctor before taking tiopronin
tablets? Before taking tiopronin tablets, tell your doctor
about:
- all healthcare conditions you may have and any medications you
take including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
- if you are pregnant or plan to become pregnant.
- if you are breastfeeding or plan to breastfeed.
What are the possible side effects of tiopronin tablets?
Tiopronin tablets can cause proteinuria (high amounts of protein in
urine), including serious kidney problems, and hypersensitivity
reactions (including fever, rash, joint pain and enlarged or
swollen lymph nodes).
The most common side effects of tiopronin tablets include
nausea, diarrhea or soft stools, sores in the mouth, rash, fatigue,
fever, muscle or joint pain, high amounts of protein in urine, and
vomiting.
These are not all the possible side effects of tiopronin
tablets. For more information, ask your doctor or pharmacist.
For more information, please see accompanying Prescribing
Information. A copy may be requested from Teva U.S. Medical
Information at 888-TEVA-USA (888-838-2872), 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 the launch of our 100 mg strength generic version of
THIOLA® (tiopronin) tablets in the United States, 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 of our 100 mg strength generic version
of THIOLA® (tiopronin) tablets;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; consolidation of our customer base and commercial
alliances among our customers; delays in launches of new generic
products; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for
generic versions of significant products; our ability to develop
and commercialize biopharmaceutical products; competition for our
specialty products, including AUSTEDO®, AJOVY® and COPAXONE®; our
ability to achieve expected results from investments in our product
pipeline; our ability to develop and commercialize additional
pharmaceutical products; 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: uncertainty
regarding the magnitude, duration, and geographic reach of the
COVID-19 pandemic and its impact on our business, financial
condition, operations, cash flows, and liquidity and on the economy
in general; our ability to successfully execute and maintain the
activities and efforts related to the measures we have taken or may
take in response to the COVID-19 pandemic and associated costs
therewith; effectiveness of our optimization efforts; our ability
to attract, hire and retain highly skilled personnel; manufacturing
or quality control problems; interruptions in our supply chain;
disruptions of information technology systems; breaches of our data
security; variations in intellectual property laws; challenges
associated with conducting business globally, including political
or economic instability, major hostilities or terrorism; costs and
delays resulting from the extensive pharmaceutical regulation to
which we are subject or delays in governmental processing time due
to travel and work restrictions caused by the COVID-19 pandemic;
the effects of reforms in healthcare regulation and reductions in
pharmaceutical pricing, reimbursement and coverage; significant
sales to a limited number of customers; our ability to successfully
bid for suitable acquisition targets or licensing opportunities, or
to consummate and integrate acquisitions; and our prospects and
opportunities for growth if we sell assets;
- compliance, regulatory and litigation matters, including:
failure to comply with complex legal and regulatory environments;
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications and our ability to
reach a final resolution of the remaining opioid-related
litigation; scrutiny from competition and pricing authorities
around the world, including our ability to successfully defend
against the U.S. Department of Justice criminal charges of Sherman
Act violations; potential liability for patent infringement;
product liability claims; failure to comply with complex Medicare
and Medicaid reporting and payment obligations; compliance with
anti-corruption sanctions and trade control laws; 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 this press release and in our
Annual Report on Form 10-K for the year ended December 31, 2020,
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 THIOLA EC® is a registered trademark of
Mission Pharmacal Company.
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