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MONMOUTH JUNCTION, July 20, 2022 / PRNewswire/ – Tris Pharma, Inc. (“Tris”), a fully integrated pharmaceutical company with a robust portfolio of CNS products announced that the U.S. Court of Appeals for the Federal Circuit (CAFC) issued its decision on July 7, 2022 upholding the validity and infringement of various patents relating to Quillivant XR® (methylphenidate HCl).

In December 2020, the U.S. Federal District Court for the District of Delaware issued a favorable decision finding that the Quillivant XR patents were valid and that a generic methylphenidate product proposed by Actavis Laboratories FL, incorporated in its Abbreviated New Drug Application (ANDA) would infringe the asserted patents. The CAFC decision confirms the lower court finding and prevents Actavis from launching a generic version of Quillivant XR until the expiration of the patent portfolio providing exclusivity until February 2031.

As Tris’s most used and fastest growing branded product, this decision will continue to allow the thousands of patients who benefit from the product to continue to do so with no interruption or change in experience for a long time.

“We are very pleased with the ruling of the CAFC, which affirms the strength of our patents protecting Quillivant XR.” said Ketan Mehta, Founder and Chief Executive Officer of Tris Pharma. “The decision validates Tris’s pioneering research to develop innovative new medicines that improve the lives of patients.”

Quillivant XR is approved for treatment of ADHD in people 6 years and older. See Approved Use and Important Safety Information, including Boxed Warning about Abuse and Dependence, 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.

Tris Pharma and the Tris Pharma logo are trademarks of Tris Pharma, Inc.

© 2022 Tris Pharma, Inc. All rights reserved.

APPROVED USE

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

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

IMPORTANT SAFETY INFORMATION

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

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

The following have been reported with the use of methylphenidate hydrochloride and other stimulant medicines:

• Heart-related problems:
  • Sudden death in patients who have heart problems or heart defects
  • Stroke and heart attack in adults
  • Increased blood pressure and heart rate
  • Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with Quillivant XR
• Mental (psychiatric) problems:
  • New or worse behavior and thought problems
  • New or worse bipolar illness
  • May cause new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms
• Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon):
  • Fingers or toes may feel numb, cool, painful, or may change color from pale, to blue, to red

Call your healthcare provider right away if you or your child have any:

• Heart-related symptoms such as chest pain, shortness of breath, or fainting
• New or worsening mental (psychiatric) symptoms or new manic symptoms
• Signs of unexplained wounds appearing on fingers or toes while taking Quillivant XR

Quillivant XR may not be right for you or your child. Tell your healthcare provider if:

• You or your child have, or have a family history of, heart problems, heart defects, or high blood pressure
• You or your child have mental problems, including psychosis (hearing voices, believing things that are not true, are suspicious), mania, bipolar illness, or depression, or a family history of suicide, bipolar illness, or depression
• You or your child have circulation problems in fingers and toes
• You are pregnant or plan to become pregnant. It is not known if Quillivant XR will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant
• You are breastfeeding or plan to breastfeed. Quillivant XR passes into your breast milk. You and your doctor should decide if you will take Quillivant XR or breastfeed

What should I avoid while taking Quillivant XR?
Quillivant XR should not be taken with MAOI medicines or if you stopped taking an MAOI in the last 14 days. Do not drink alcohol while taking Quillivant XR. This may cause a faster release of your methylphenidate dose.

What are the possible side effects of Quillivant XR?
Quillivant XR may cause serious side effects, including:

• See “What is the most important information I should know about Quillivant XR?” for information on reported heart and mental problems

Other serious side effects include:

• Painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism seek medical help right away. Because priapism can cause long-lasting damage, it should be checked by a healthcare provider right away
• Slowing of growth (height and weight) in children

Common side effects include:

• Decreased appetite
• Trouble sleeping
• Nausea
• Vomiting
• Indigestion
• Stomach pain
• Weight loss
• Anxiety
• Dizziness
• Irritability
• Mood swings
• Fast heart beat
• Increased blood pressure

These are not all the possible side effects of Quillivant XR.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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