Novartis Corporation
230 Park Avenue, 21st Floor
New York, NY 10169
USA
http://www.us.novartis.com
MEDIA RELEASE • MEDIA RELEASE • MEDIA RELEASE
Novartis Group maximizes patient access and choice with launch of
Sandoz authorized generic Diovan HCT® in the US

Novartis Pharmaceuticals Corporation (NPC) continues to market branded Diovan®
and Diovan HCT®, and offer $4 co-pay card program

With over 15 million patients1, Diovan® and Diovan HCT® are the #1 prescribed
branded ARB medicine in the US
New York, September 21, 2012 – Sandoz, the generics division of Novartis, today
®
announced the US introduction of an authorized generic version of Diovan HCT
(valsartan and hydrochlorothiazide) tablets for the treatment of high blood pressure
(HBP).
“We are pleased to offer a high-quality generic version of this leading treatment to the
tens of millions of Americans working to control their blood pressure,” said Don
DeGolyer, President of Sandoz US. “As part of the Novartis Group, which has a leading
global position in both branded and generic medicines, we are uniquely positioned to
maximize access and choice for patients and healthcare professionals.”
®
Novartis Pharmaceuticals Corporation (NPC) will continue to market branded Diovan
and Diovan HCT. The company will also offer its Diovan co-pay card program to eligible
patients who are prescribed Diovan or Diovan HCT and who want to continue taking the
branded medication. Additionally, Diovan and Diovan HCT will continue to be offered
through the Novartis Patient Assistance Foundation, Inc. (NPAF), to further improve
access for eligible patients who lack prescription drug coverage or cannot afford their
prescriptions.
“This collaboration between NPC and Sandoz helps us make leading treatments like
Diovan HCT available in multiple forms to meet US patient needs,” said André Wyss,
President of NPC. “This is in line with the Novartis Group’s overall commitment to
providing options that support access and benefit patients.”
Diovan and Diovan HCT have been prescribed by healthcare professionals for over a
decade and have a strong heritage in the management of HBP, a condition that affects
approximately one in three US adults.2 Since 2002, together they have been the #1
prescribed branded angiotensin receptor blocker (ARB)-containing product in the US.
US net sales for Diovan and Diovan HCT in 2011 were approximately USD 2.3 billion.
Sandoz will market the authorized generic version of Diovan HCT in 80/12.5 mg,
160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg strength tablets. These are the
same strengths marketed for the branded version of Diovan HCT.
®
®
Important Safety Information for Diovan and Diovan HCT
DIOVAN and DIOVAN HCT can cause harm or death to an unborn baby. Talk to your
doctor about other ways to lower your blood pressure if you plan to become pregnant. If
you get pregnant while taking DIOVAN or DIOVAN HCT, tell your doctor right away.
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Do not take DIOVAN HCT if you have low or no urine output (anuria), or if you have
allergic reactions to certain drugs known as sulfonamides.
Serious side effects may occur with DIOVAN and DIOVAN HCT, such as:
• Low blood pressure (hypotension), especially if you take water pills, are on a lowsalt diet, get dialysis treatments, have heart problems, or get sick with vomiting or
diarrhea. Lie down if you feel faint or dizzy and call your doctor right away.
• Kidney problems. Call your doctor if you have swelling in your feet, ankles, or
hands or have unexplained weight gain.
Serious side effects may occur with DIOVAN HCT, such as:
• Skin rash. Call your doctor right away if you get an unusual rash.
• Eye problems. Call your doctor right away if you have eye pain or decrease in
vision.
Tell your doctor about all your medical conditions, including if you are pregnant or plan to
become pregnant, have any allergies, have a heart condition, have liver or kidney
problems, have or have had gallstones, have lupus, or are breast-feeding. DIOVAN or
DIOVAN HCT may pass into your breast milk and can harm your baby. You should not
take DIOVAN or DIOVAN HCT and breast-feed. People with and without allergy
problems or asthma who take DIOVAN HCT may get allergic reactions.
Tell your doctor about all the medicines you take. If you are taking DIOVAN or DIOVAN
HCT, especially tell your doctor if you take other medicines for high blood pressure or a
heart problem; water pills (diuretics); potassium supplements or a salt substitute
containing potassium; or aspirin or other medicines called non-steroidal anti-inflammatory
drugs (NSAIDs, like ibuprofen or naproxen); diabetes medicine including insulin; narcotic
pain medicines; sleeping pills; or lithium, a medicine used to treat some types of
depression.
If you are taking DIOVAN HCT, tell your doctor if you develop any of the following signs
of fluid and electrolyte problems: dry mouth, thirst, weakness, lack of energy, drowsiness,
restlessness, confusion, seizures, muscle pain or cramps, muscle fatigue, low blood
pressure, very low urine output, fast heartbeat, or nausea or vomiting.
The most common side effects seen with DIOVAN in people with high blood pressure are
headache, dizziness, flu symptoms, tiredness, and stomach (abdominal) pain.
The most common side effects of DIOVAN seen in people with heart failure are
dizziness, low blood pressure, diarrhea, joint and back pain, tiredness, and high blood
potassium.
Common side effects of DIOVAN used to treat people after a heart attack that caused
them to stop taking the drug are low blood pressure, cough, high blood creatinine
(decreased kidney function), and rash.
The most common side effect with DIOVAN HCT is cold-like symptoms.
For further information, please see full Prescribing Information, including Boxed
WARNING, for Diovan and Diovan HCT.
Diovan: http://www.pharma.us.novartis.com/product/pi/pdf/diovan.pdf
Diovan HCT: http://www.pharma.us.novartis.com/product/pi/pdf/diovan_hct.pdf
Disclaimer
The foregoing release contains forward-looking statements that can be identified by
terminology such as "launches," "introduction," "will," or similar expressions, or by
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express or implied discussions regarding potential future revenues from valsartan
products. You should not place undue reliance on these statements. Such forwardlooking statements reflect the current views of management regarding future events, and
involve known and unknown risks, uncertainties and other factors that may cause actual
results to be materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that the Novartis
Group’s valsartan product will achieve any particular levels of revenue in the future. In
particular, management's expectations could be affected by, among other things,
unexpected regulatory actions or delays or government regulation generally, including
potential FDA approval of additional generic versions of valsartan products; competition
in general; government, industry and general public pricing pressures, and unexpected
reimbursement decisions; unexpected manufacturing issues; the impact that the
foregoing factors could have on the values attributed to the Novartis Group's assets and
liabilities as recorded in the Group's consolidated balance sheet, and other risks and
factors referred to in Novartis AG's current Form 20-F on file with the US Securities and
Exchange Commission. Should one or more of these risks or uncertainties materialize, or
should underlying assumptions prove incorrect, actual results may vary materially from
those anticipated, believed, estimated or expected. Novartis is providing the information
in this press release as of this date and does not undertake any obligation to update any
forward-looking statements contained in this press release as a result of new information,
future events or otherwise.
About Novartis
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets
innovative prescription drugs used to treat a number of diseases and conditions,
including cardiovascular, dermatological, central nervous system, bone disease, cancer,
organ transplantation, psychiatry, infectious disease and respiratory. The company's
mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an
affiliate of Novartis AG, which provides innovative healthcare solutions that address the
evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines, eye care,
cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-thecounter and animal health products. Novartis is the only global company with leading
positions in all these areas. In 2011, the Group's continuing operations achieved net
sales of USD 58.6 billion, while approximately USD 9.6 billion (USD 9.2 billion excluding
impairment and amortization charges) was invested in R&D throughout the Group.
Novartis Group companies employ approximately 124,000 full-time-equivalent associates
and operate in more than 140 countries around the world. For more information, please
visit http://www.novartis.com.
About Sandoz
Sandoz, a Division of the Novartis group, is the second-largest generic pharmaceuticals
company globally, offering a broad range of about 1,000 high-quality, affordable products
that are no longer protected by patents. With approximately 25,000 employees in 140
countries, Sandoz holds the #1 position globally in biosimilars as well as generic
injectables, ophthalmics, dermatology, and antibiotics. Key product groups include
antibiotics, treatments for central nervous system disorders, gastrointestinal medicines,
cardiovascular treatments, and hormone therapies. Sandoz develops, produces, and
markets these medicines along with pharmaceutical and biotechnological active
substances and anti-infectives. In addition to strong organic growth in recent years,
Sandoz has made a series of acquisitions including Lek (Slovenia), Sabex (Canada),
Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US),
and Fougera Pharmaceuticals (US). In 2011, Sandoz posted sales of USD 9.5 billion. For
more information, please visit www.sandoz.com.
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References
1.
2.
United States Securities and Exchange Commission, FORM 20-F. Filed on January 25, 2012.
http://www.sec.gov/Archives/edgar/data/1114448/000104746912000354/a2205643z20-f.htm
Centers for Disease Control and Prevention. Vital signs: prevalence, treatment, and control of
hypertension--United States, 1999-2002 and 2005-2008. MMWR. 2011; 60(4):103-8.2.
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Novartis Media Relations
Julie Masow
Novartis Corporation
+1 212 830 2465 (direct)
+1 862 579 8456 (mobile)
julie.masow@novartis.com
Anna Frable
Novartis Pharmaceuticals Corporation
+1 862 778 5388 (direct)
+1 732 673 5262 (mobile)
anna.frable@novartis.com
Chris Lewis
Sandoz US Communications
+1 609 627 5287 (direct)
+1 609 619 7454 (mobile)
chris.lewis@sandoz.com
e-mail: us.mediarelations@novartis.com
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