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Tris announces US District Court Upholds Validity of Quillivant XR® Patents; Rules Teva Infringes Tris Patents

MONMOUTH JUNCTION, December 1, 2020 / PRNewswire/ – Tris Pharma, Inc. (“Tris”), a specialty pharmaceutical company with a robust portfolio of approved products for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and related disorders, announced the decision by the US District Court for the District of Delaware to uphold the validity of various patents relating to Quillivant XR® (methylphenidate HCl)

The decision further holds that a generic methylphenidate product proposed by Actavis Laboratories FL, incorporated in its Abbreviated New Drug Application (ANDA) will infringe the asserted Tris patents.  In particular, the Court found that “all the asserted claims of the asserted patents before me on remand are not invalid and that Defendants directly infringe, contributorily infringe, and induce the infringement of each of the asserted claims.”  The ruling prevents Activis from launching generic versions of Quillivant XR until the expiration of the patent portfolio providing exclusivity until February 2031. 

 “This is a huge win for Tris and provides for long exclusive life for a key portfolio product. We welcome this decision upholding the validity of the Quillivant XR patents, as it reflects the innovative nature of our LiquiXR® technology which was used to develop Quillivant XR and our other branded ADHD medications.” said Ketan Mehta, Founder and Chief Executive Officer of Tris Pharma.  “Validation of our intellectual property permits Tris to continue investing in innovation to develop novel treatments that improve patients’ lives.”

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 Pharma is a New Jersey-based specialty pharmaceutical company focused on the development and commercialization of innovative medicines that address unmet patient needs. Tris has used its LiquiXR technology platform to develop a portfolio of differentiated solid and liquid medications as well as a robust pipeline which spans multiple therapeutic categories, and its technology has formed the basis for numerous mutually value-adding development partnerships. Within the United States Tris promotes its portfolio of ADHD products (described at www.TrisADHD.com) using its pediatric and CNS-focused sales force. For more information, please visit www.trispharma.com.

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                              Indigestion                              Irritability

Trouble sleeping                                 Stomach pain                          Mood swings

Nausea                                                Weight loss                             Fast heart beat

Vomiting                                             Anxiety                                   Increased blood pressure

                                                            Dizziness                                

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.