[{"orgOrder":0,"company":"Ironshore Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ironshore to Present a Dose Conversion Poster at the 2020 American Society of Clinical Psychopharmacology Virtual Scientific Poster Session","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase IV"},{"orgOrder":0,"company":"Tris Pharma Inc","sponsor":"KYE Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Tris Pharma and KYE Pharmaceuticals Announce Exclusive License Agreement to Commercialize Tris ADHD Products in Canada","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase IV"},{"orgOrder":0,"company":"Tris Pharma Inc","sponsor":"Medison Pharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Tris Pharma and Medison Pharma Announce Exclusive License Agreement to Commercialize Tris' Quillivant XR in Israel","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase IV"},{"orgOrder":0,"company":"InfectoPharm Drugs and Consilium","sponsor":"Societal CDMO","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Societal CDMO Signs Three-Year Manufacturing and Supply Agreement With InfectoPharm for Ritalin LA in Europe","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase IV","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase IV"},{"orgOrder":0,"company":"Adlon Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Supplemental New Drug Application for Adhansia XR\u00ae (methylphenidate HCl) Extended-Release Capsules CII","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase IV"},{"orgOrder":0,"company":"Societal CDMO","sponsor":"InfectoPharm Drugs and Consilium","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Societal CDMO Signs Three-Year Manufacturing and Supply Agreement With InfectoPharm for Ritalin LA\u00ae in Europe","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase IV"},{"orgOrder":0,"company":"Dr. Reddy\\'s Laboratories","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dr. Reddy's Laboratories Announces the Launch of Methylphenidate Hydrochloride Extended-Release Tablets USP, in the U.S. Market","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase IV","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase IV"},{"orgOrder":0,"company":"Brand Institute","sponsor":"Osmotica Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Brand Institute Partners on Brand Name Development for FDA Approved Treatment for Attention Deficit Hyperactivity Disorder (ADHD)","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase IV","country":"","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase IV"},{"orgOrder":0,"company":"Tris Pharma Inc","sponsor":"Teva Pharmaceutical Industries","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Tris Pharma Announces US District Court Upholds Validity of QuilliChew ER\u00ae Patents; Rules Teva Infringes Tris Patents","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase IV"},{"orgOrder":0,"company":"Tris Pharma Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Tris Pharma Secures First ex-US Authorizations for Quillivant ER Oral Suspension and Quillivant ER Chewable Tablet for the Treatment of Attention Deficit Hyperactivity Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase IV"},{"orgOrder":0,"company":"Alora Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alora Pharmaceuticals, LLC Announces the Availability of Once-Daily Relexxii\u00ae for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase IV"}]
Find Clinical Drug Pipeline Developments & Deals for Methylphenidate HCl
Dr. Reddy’s Methylphenidate Hydrochloride Extended-Release Tablets, USP are available in strengths of 18 mg, 27 mg, 36 mg, and 54 mg tablets in bottle count sizes of 100.
Relexxii (methylphenidate HCl) is a dopamine/norepinephrine reuptake inhibitor, small molecule drug candidate, which is currently being evaluated for the treatment of attention deficit hyperactivity disorder in patients aged 6 to 65 years.
Quillivant ER (methylphenidate) Oral Suspension and Chewable Tablet R is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder.
QuilliChew ER (methylphenidate hydrochloride) 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.
RELEXXII® (methylphenidate hydrochloride extended-release tablets) is an oral medication indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults up to the age of 65 and pediatric patients 6 years of age and older.
Ritalin LA is indicated for the treatment of attention deficit hyperactivity disorder. The product is an extended-release formulation of methylphenidate hydrochloride with a bi-modal release profile using the SODAS (Spheroidal Oral Drug Absorption System) technology.
Ritalin LA is indicated for the treatment of attention deficit hyperactivity disorder. The product is an extended-release formulation of methylphenidate hydrochloride with a bi-modal release profile using the proprietary SODAS® technology.
The sNDA approval was based on data from a randomized, double-blind, parallel-group, placebo-controlled, Phase 3 Adult Laboratory Classroom (ALC) study evaluating the safety and efficacy of Adhansia XR in adult patients diagnosed with ADHD.
Under the terms of the agreement, KYE has received exclusive rights to commercialize Tris' FDA-approved ADHD product portfolio in Canada. Also, KYE will handle all ongoing Canadian regulatory activities for the products.