COTEMPLA XR-ODT Drug Patent Profile

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When do Cotempla Xr-odt patents expire, and when can generic versions of Cotempla Xr-odt launch?

Cotempla Xr-odt is a drug marketed by Neos Theraps Inc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has eight patent family members in five countries.

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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cotempla Xr-odt

A generic version of COTEMPLA XR-ODT was approved as methylphenidate by MYLAN TECH VIATRIS on March 14^th, 2022.

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Summary for COTEMPLA XR-ODT

International Patents:	8
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Patent Applications:	4,972
Drug Prices:	Drug price information for COTEMPLA XR-ODT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COTEMPLA XR-ODT
What excipients (inactive ingredients) are in COTEMPLA XR-ODT?	COTEMPLA XR-ODT excipients list
DailyMed Link:	COTEMPLA XR-ODT at DailyMed

Drug patent expirations by year for COTEMPLA XR-ODT

Pharmacology for COTEMPLA XR-ODT

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

Paragraph IV (Patent) Challenges for COTEMPLA XR-ODT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COTEMPLA XR-ODT	Extended-release Orally Disintegrating Tablets	methylphenidate	8.6 mg, 17.3 mg and 25.9 mg	205489	1	2017-09-01

US Patents and Regulatory Information for COTEMPLA XR-ODT

COTEMPLA XR-ODT is protected by four US patents.

Patents protecting COTEMPLA XR-ODT

Effective dosing of a child for the treatment of ADHD with methylphenidate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN PEDIATRIC PATIENTS

Compositions and methods of making rapidly dissolving ionically masked formulations
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Patent Expiration: ⤷ Sign Up

Compositions comprising methylphenidate complexed with ion-exchange resin particles
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-001	Jun 19, 2017		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-002	Jun 19, 2017		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-001	Jun 19, 2017		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for COTEMPLA XR-ODT

When does loss-of-exclusivity occur for COTEMPLA XR-ODT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

European Patent Office

Patent: 26066
Patent: FORMES POSOLOGIQUES POUR ADMINISTRATION ORALE ET MÉTHODES DE TRAITEMENT LES UTILISANT (DOSAGE FORMS FOR ORAL ADMINISTRATION AND METHODS OF TREATMENT USING THE SAME)
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering COTEMPLA XR-ODT around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	2020504763	メチルフェニデートを用いてＡＤＨＤを処置するための小児の有効な投薬	⤷ Sign Up
European Patent Office	3585439	DOSAGE EFFICACE D'UN ENFANT POUR LE TRAITEMENT DU TDAH AVEC DU MÉTHYLPHÉNIDATE (EFFECTIVE DOSING OF A CHILD FOR THE TREATMENT OF ADHD WITH METHYLPHENIDATE)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2018085256		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration