You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 24, 2024

Details for New Drug Application (NDA): 205489


✉ Email this page to a colleague

« Back to Dashboard


NDA 205489 describes COTEMPLA XR-ODT, which is a drug marketed by Neos Theraps Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the COTEMPLA XR-ODT profile page.

The generic ingredient in COTEMPLA XR-ODT is methylphenidate. There are thirty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the methylphenidate profile page.
Summary for 205489
Tradename:COTEMPLA XR-ODT
Applicant:Neos Theraps Inc
Ingredient:methylphenidate
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 205489
Medical Subject Heading (MeSH) Categories for 205489
Suppliers and Packaging for NDA: 205489
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COTEMPLA XR-ODT methylphenidate TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 205489 NDA Neos Therapeutics Brands, LLC 70165-100 70165-100-30 5 BLISTER PACK in 1 CARTON (70165-100-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
COTEMPLA XR-ODT methylphenidate TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 205489 NDA Neos Therapeutics Brands, LLC 70165-200 70165-200-30 5 BLISTER PACK in 1 CARTON (70165-200-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORALStrength8.6MG
Approval Date:Jun 19, 2017TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jan 25, 2038Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN PEDIATRIC PATIENTS
Patent:⤷  Try a TrialPatent Expiration:Jun 5, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Jun 28, 2032Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.