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Last Updated: August 10, 2020

DrugPatentWatch Database Preview

ADZENYS XR-ODT Drug Profile

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

Adzenys Xr-odt is a drug marketed by Neos Theraps and is included in one NDA. There are four patents protecting this drug.

This drug has two patent family members in two countries.

The generic ingredient in ADZENYS XR-ODT is amphetamine. There are fifty-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amphetamine profile page.

US ANDA Litigation and Generic Entry Outlook for Adzenys 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.

Indicators of Generic Entry

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Drug patent expirations by year for ADZENYS XR-ODT
Drug Prices for ADZENYS XR-ODT

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Recent Clinical Trials for ADZENYS XR-ODT

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SponsorPhase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 2
Duke UniversityPhase 2

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Pharmacology for ADZENYS XR-ODT
Paragraph IV (Patent) Challenges for ADZENYS XR-ODT
Tradename Dosage Ingredient NDA Submissiondate
ADZENYS XR-ODT TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL amphetamine 204326 2016-05-10

US Patents and Regulatory Information for ADZENYS 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 ADZENYS XR-ODT amphetamine TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 204326-001 Jan 27, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Neos Theraps ADZENYS XR-ODT amphetamine TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 204326-005 Jan 27, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Neos Theraps ADZENYS XR-ODT amphetamine TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 204326-006 Jan 27, 2016 RX Yes Yes   Start Trial   Start Trial Y   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:

Express Scripts
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