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Last Updated: May 26, 2022

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 seven 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. Two 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 14th, 2022.

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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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN PEDIATRIC PATIENTS

Compositions and methods of making rapidly dissolving ionically masked formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions comprising methylphenidate complexed with ion-exchange resin particles
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions comprising methylphenidate complexed with ion-exchange resin particles
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Neos Theraps Inc COTEMPLA XR-ODT methylphenidate TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 205489-002 Jun 19, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Neos Theraps Inc COTEMPLA XR-ODT methylphenidate TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 205489-001 Jun 19, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

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.

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 See Plans and Pricing
South Korea 20190107655 ADHD의 치료를 위한 메틸페니데이트의 효과적인 아동 투여 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2013003622 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Medtronic

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