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Last Updated: June 6, 2020

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COTEMPLA XR-ODT Drug 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 three patents protecting this drug.

This drug has two patent family members in two 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.

US ANDA Litigation and Generic Entry Outlook for Cotempla Xr-odt

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (methylphenidate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Paragraph IV (Patent) Challenges for COTEMPLA XR-ODT
Tradename Dosage Ingredient NDA Submissiondate
COTEMPLA XR-ODT TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL methylphenidate 205489 2017-09-01

US Patents and Regulatory Information for COTEMPLA XR-ODT

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   Start Trial   Start Trial Y   Start Trial
Neos Theraps Inc COTEMPLA XR-ODT methylphenidate TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 205489-002 Jun 19, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
Neos Theraps Inc COTEMPLA XR-ODT methylphenidate TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 205489-001 Jun 19, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Neos Theraps Inc COTEMPLA XR-ODT methylphenidate TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 205489-003 Jun 19, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
McKesson
Merck
Harvard Business School
Medtronic

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