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MONMOUTH JUNCTION, NJ, August 18, 2022/ PRNewswire/ – Tris Pharma, Inc. (“Tris”) a fully integrated pharmaceutical company with a robust portfolio of CNS products announced today the decision by the US District Court for the District of New Jersey to uphold the validity of various patents relating to QuilliChew ER^® (methylphenidate hydrochloride) extended-release chewable tablets, for oral use, CII.

The decision further holds that a generic methylphenidate product proposed by Teva Pharmaceuticals USA, Inc., incorporated in its Abbreviated New Drug Application (ANDA) will infringe the asserted Tris patents. In particular, the Court found that “Tris has shown by a preponderance of the evidence that all valid asserted claims … were infringed by Teva’s ANDA product”. The ruling prevents Teva from launching generic versions of QuilliChew ER until the expiration of Tris’s patent portfolio providing exclusivity until August 2033.

“The decision of the District Court not only confirms the validity and infringement of our QuilliChew ER patents, but also validates the innovative nature of our LiquiXR^® technology which we utilized to develop QuilliChew ER and our other branded ADHD medications.” said Ketan Mehta, Founder and Chief Executive Officer of Tris Pharma. “This victory will confirm exclusivity for a key portfolio product and support ongoing innovation to address unmet needs in ADHD patients.”

QuilliChew ER is approved for treatment of ADHD in people 6 years and older. See products’ Approved Use and Important Safety Information, including Boxed Warning about Abuse and Dependence, below.

QuilliChew ER is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep QuilliChew ER in a safe place to protect it from theft. Never give your QuilliChew ER to anyone else because it may cause death or harm them. Selling or giving away QuilliChew ER may harm others and is against the law. See additional important safety information below.

About Tris Pharma
Tris is a fully integrated, innovation-driven CNS company that provides a differentiated approach to target unmet medical needs, including the application of novel technologies designed to enhance patient benefits across therapeutic categories. Tris’s CNS portfolio includes treatments for pain; addiction; spasticity in multiple sclerosis, cerebral palsy; narcolepsy; and ADHD. For more information, please visit www.trispharma.com and www.trismedical.com.

APPROVED USE
QuilliChew ER is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years and older. QuilliChew ER may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if QuilliChew ER is safe and effective in children under 6 years of age.

IMPORTANT SAFETY INFORMATION
QuilliChew ER is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep QuilliChew ER in a safe place to prevent misuse and abuse. Selling or giving away QuilliChew ER may harm others and is against the law. Tell your physician if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

QuilliChew ER should not be taken if you or your child are allergic to methylphenidate hydrochloride or any of the ingredients in QuilliChew ER, or are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.

QuilliChew ER can cause serious side effects. Tell the doctor:

• if you or your child have heart problems, heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in children 6 to 17 years old with heart problems or defects, and sudden death, stroke, and heart attack have happened in adults. Your doctor should check you or your child carefully for heart problems before starting QuilliChew ER. Since increases in blood pressure and heart rate may occur, the doctor should regularly check these during treatment. Call the doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking QuilliChew ER.
• if you or your child have mental problems, or a family history of suicide, bipolar illness, or depression. This is important because new or worsening behavior and thought problems or bipolar illness may occur. New symptoms such as seeing or hearing things that are not real, believing things that are not true, being suspicious, or having new manic symptoms may occur. Call the doctor right away if there are any new or worsening mental symptoms during treatment.
• if you or your child have circulation problems in fingers and toes (called peripheral vasculopathy, including Raynaud’s phenomenon). Fingers or toes may feel numb, cool, painful, sensitive to temperature, and/or change color from pale, to blue, to red. Call the doctor right away if any signs of unexplained wounds appear on fingers or toes while taking QuilliChew ER.
• if your child is having slowing of growth (height and weight); Your child should have his or her height and weight checked often while taking QuilliChew ER.
• if you or your child develop painful and prolonged erections (priapism), seek medical help right away. Priapism has occurred with methylphenidate (QuilliChew ER). Because priapism can cause long-lasting damage, it should be checked by a doctor right away.
• if you or your child have phenylketonuria (PKU). QuilliChew ER contains phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with PKU or who are allergic to phenylalanine
• if you or your child are pregnant or plan to become pregnant. It is not known if QuilliChew ER will harm your unborn baby. Tell your doctor if you or your child become pregnant during treatment with QuilliChew ER.
• if you or your child is breastfeeding or plan to breastfeed. QuilliChew ER passes into breast milk. You or your child should not breastfeed while you are taking QuilliChew ER.

Common side effects of methylphenidate products include:

• decreased appetite
• indigestion
• irritability
• trouble sleeping
• stomach pain
• mood swings
• nausea
• weight loss
• fast heart beat
• vomiting
• anxiety
• increased blood pressure
• dizziness

Talk to your doctor if you or your child have any side effects that bother you or do not go away.

Avoid drinking alcohol while taking QuilliChew ER.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see Full Prescribing Information, including Boxed Warning about Abuse and Dependence, and Medication Guide.

QuilliChew ER^® and LiquiXR^® are registered trademarks of Tris Pharma, Inc.
©2022 Tris Pharma, Inc. All rights reserved.