{"id":1709,"date":"2022-08-18T16:52:45","date_gmt":"2022-08-18T15:52:45","guid":{"rendered":"https:\/\/tris.sambrownprojects.com\/tris-pharma-announces-us-district-court-upholds-validity-of-quillichew-er-patents-rules-teva-infringes-tris-patents\/"},"modified":"2022-08-18T16:52:45","modified_gmt":"2022-08-18T15:52:45","slug":"tris-pharma-announces-us-district-court-upholds-validity-of-quillichew-er-patents-rules-teva-infringes-tris-patents","status":"publish","type":"post","link":"https:\/\/www.trispharma.com\/tris-pharma-announces-us-district-court-upholds-validity-of-quillichew-er-patents-rules-teva-infringes-tris-patents\/","title":{"rendered":"Tris Pharma Announces US District Court Upholds Validity of QuilliChew ER\u00ae Patents; Rules Teva Infringes Tris Patents"},"content":{"rendered":"\n

MONMOUTH JUNCTION, NJ, August 18, 2022\/ PRNewswire\/ – Tris Pharma, Inc. (\u201cTris\u201d) 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\u00ae<\/sup> (methylphenidate hydrochloride) extended-release chewable tablets, for oral use, CII.<\/p>\n\n\n\n

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 \u201cTris has shown by a preponderance of the evidence that all valid asserted claims \u2026 were infringed by Teva\u2019s ANDA product\u201d. The ruling prevents Teva from launching generic versions of QuilliChew ER until the expiration of Tris\u2019s patent portfolio providing exclusivity until August 2033. <\/p>\n\n\n\n

\u201cThe 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\u00ae<\/sup> technology which we utilized to develop QuilliChew ER and our other branded ADHD medications.\u201d said Ketan Mehta, Founder and Chief Executive Officer of Tris Pharma. \u201cThis victory will confirm exclusivity for a key portfolio product and support ongoing innovation to address unmet needs in ADHD patients.\u201d <\/p>\n\n\n\n

QuilliChew ER is approved for treatment of ADHD in people 6 years and older. See products\u2019 Approved Use and Important Safety Information, including Boxed Warning about Abuse and Dependence, below.<\/p>\n\n\n\n

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.<\/strong> 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.<\/p>\n\n\n\n

About Tris Pharma<\/strong>
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\u2019s CNS portfolio includes treatments for pain; addiction; spasticity in multiple sclerosis, cerebral palsy; narcolepsy; and ADHD. For more information, please visit www.trispharma.com<\/a> and www.trismedical.com<\/a>.<\/p>\n\n\n\n

APPROVED USE<\/strong>
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.<\/p>\n\n\n\n

It is not known if QuilliChew ER is safe and effective in children under 6 years of age.<\/p>\n\n\n\n

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.<\/strong> Tell your physician if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.<\/p>\n\n\n\n

QuilliChew ER should not be taken if you or your child<\/strong> 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.<\/p>\n\n\n\n

QuilliChew ER can cause serious side effects. Tell the doctor:<\/strong><\/p>\n\n\n\n