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Aralez Announces District Court Decision to Uphold VIMOVO (Naproxen/Esomeprazole Magnesium) Patents
-Patents Covering VIMOVO Infringed by Proposed Generics Developed by
"We are very pleased that the fair and appropriate ruling regarding this litigation was rendered by the
VIMOVO has 14 Orange Book listed patents with terms that extend to 2031. The '907 patent is also listed in the Orange Book for Yosprala (aspirin/omeprazole) and has been asserted against
VIMOVO (naproxen/esomeprazole magnesium) is a fixed-dose combination of delayed-release enteric-coated naproxen, a non-steroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole magnesium, a stomach acid-reducing proton pump inhibitor (PPI), approved for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO is not interchangeable with the individual components of naproxen and esomeprazole magnesium.
VIMOVO is not recommended for use in children younger than 18 years of age. VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond six months. VIMOVO should be used at the lowest dose and for the shortest amount of time as directed by your health care provider. For Full Prescribing Information please see www.VIMOVO.com.
Important Safety Information
- Nonsteroidal anti-inflammatory drugs (NSAIDs), including naproxen, a component of VIMOVO, may increase the chance of a heart attack or stroke, which can be fatal. This chance increases with longer use and in people who have heart disease or risk factors for heart disease.
- VIMOVO should not be used before or after a type of heart surgery called coronary artery bypass graft (CABG).
- NSAID-containing medications like VIMOVO may increase the chance of stomach and intestinal problems, such as bleeding or an ulcer. These problems can happen without warning and can lead to death. Older patients may have a greater chance of developing these problems.
VIMOVO is not right for everyone, including patients who have had an asthma attack, hives or other allergic reaction with aspirin or any other NSAID medicine, patients who are allergic to any of the ingredients in VIMOVO or women in late stages of pregnancy.
Serious allergic reactions, including skin reactions, can occur without warning and can be life-threatening; discontinue use of VIMOVO at the first appearance of a skin rash or if you develop sudden wheezing; swelling of the lips, tongue or throat; fainting or problems swallowing.
VIMOVO should be used at the lowest dose and for the shortest amount of time as directed by your health care provider.
Tell your health care provider right away if you develop signs of active bleeding from any source.
VIMOVO can lead to onset of new hypertension or worsening of existing high blood pressure, either of which may contribute to an increased risk of a heart attack or stroke.
Speak with your health care provider before starting VIMOVO if you
- Have a history of ulcers or bleeding in the stomach or intestines
- Have heart problems, high blood pressure, or are taking high blood pressure medications
- Have kidney or liver problems
Tell your doctor about all of the medicines you take, prescription and non-prescription drugs, including clopidogrel, vitamins and herbal supplements. VIMOVO may affect how other medicines work and other medicines may affect how VIMOVO works.
VIMOVO may increase your risk of getting severe diarrhea. Call your doctor right away if you have watery stool, stomach pain and fever that does not go away.
Talk to your health care provider about your risk for bone fractures and developing low levels of magnesium if you take VIMOVO for a long period of time.
Talk to your health care provider about your risk for developing low levels of magnesium if you take VIMOVO for a long period of time.
The most common side effects of VIMOVO include: inflammation of the lining of the stomach, indigestion, diarrhea, stomach ulcers, abdominal pain and nausea.
This press release includes certain statements that constitute "forward-looking statements" within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, statements regarding the impact of the District Court's ruling on the '907 and '285 patents; patent protection with respect to VIMOVO and Yosprala; the strength of the Company's intellectual property portfolio for VIMOVO and Yosprala; the Company's commitment to aggressively defending its intellectual property; and other statements that are not historical facts, and such statements are typically identified by use of terms such as "may," "will," "would," "should," "could," "expect," "plan," "intend," "anticipate," "believe," "estimate," "predict," "likely," "potential," "continue" or the negative or similar words, variations of these words or other comparable words or phrases, although some forward-looking statements are expressed differently.
You should be aware that the forward-looking statements included herein represent management's current judgment and expectations, and are based on current estimates and assumptions made by management in light of its experience and perception of historical trends, current conditions and expected future developments, as well as other factors that it believes are appropriate and reasonable under the circumstances, but there can be no assurance that such estimates and assumptions will prove to be correct and, as a result, the forward-looking statements based on those estimates and assumptions could prove to be incorrect. Accordingly, actual results, level of activity, performance or achievements or future events or developments could differ materially from those expressed or implied in the forward-looking statements.
In addition, the Company's operations involve risks and uncertainties, many of which are outside of its control, and any one or any combination of these risks and uncertainties could also affect whether the forward-looking statements ultimately prove to be correct and could cause its actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward- looking statements. These risks and uncertainties include, without limitation, risks regarding appeal of the District Court's decision and whether the decision is upheld on such an appeal and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in the Company's
Executive Director, Investor Relations & Corporate Communications
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