Last Updated: September 24, 2026

Details for New Drug Application (NDA): 205489

✉ Email this page to a colleague

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 two suppliers. 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 is one drug master file entry for this compound. Five 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

Pharmacology for NDA: 205489

Physiological Effect	Central Nervous System Stimulation

Medical Subject Heading (MeSH) Categories for 205489

Central Nervous System Stimulants
Dopamine Uptake Inhibitors

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 AUTHORIZED GENERIC	Neos Therapeutics, LP	62542-100	62542-100-31	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62542-100-31)
COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489	NDA AUTHORIZED GENERIC	Neos Therapeutics, LP	62542-250	62542-250-31	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62542-250-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL			Strength	8.6MG
Approval Date:	Jun 19, 2017	TE:	AB	RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Jan 25, 2038	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN PEDIATRIC PATIENTS
Patent:	⤷ Start Trial	Patent Expiration:	Jun 5, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Start Trial	Patent Expiration:	Jun 28, 2032	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 205489

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-001	Jun 19, 2017	⤷ Start Trial	⤷ Start Trial
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-003	Jun 19, 2017	⤷ Start Trial	⤷ Start Trial
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-002	Jun 19, 2017	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.