X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
Details:
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.
Lead Product(s): Methylphenidate Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Methylphenidate Hydrochloride-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2020
Details:
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.
Lead Product(s): Methylphenidate Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Relexxii
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2023
Details:
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.
Lead Product(s): Methylphenidate Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Quillivant ER
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2023
Details:
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.
Lead Product(s): Methylphenidate Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: QuilliChew
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Teva Pharmaceutical Industries
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 18, 2022
Details:
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.
Lead Product(s): Methylphenidate Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Relexxii
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Osmotica Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 11, 2022
Details:
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.
Lead Product(s): Methylphenidate Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Ritalin LA
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Societal CDMO
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 05, 2022
Details:
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.
Lead Product(s): Methylphenidate Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Ritalin LA
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: InfectoPharm Drugs and Consilium
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 05, 2022
Details:
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.
Lead Product(s): Methylphenidate Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Adhansia XR
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2021
Details:
Under the terms of the licensing agreement, Medison has been granted exclusive rights to commercialize Tris’ FDA-approved Quillivant XR in Israel.
Lead Product(s): Methylphenidate Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Quillivant XR
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Medison Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement November 17, 2020
Details:
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.
Lead Product(s): Methylphenidate Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Quillivant XR
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: KYE Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 09, 2020
Details:
The data presented in the poster may help guide clinicians to target an appropriate dose range of JORNAY PM extended-release capsules CII, which was approved in August 2018 by the U.S. FDA for the treatment of ADHD in patients 6 years and older.
Lead Product(s): Methylphenidate Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Jornay PM
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
