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Last Updated: June 25, 2021

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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 and one Paragraph IV challenge.

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.

DrugPatentWatch® Generic Entry Outlook for Adzenys Xr-odt

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 9, 2026. This may change due to patent challenges or generic licensing.

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

See drug prices for ADZENYS XR-ODT

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ADZENYS XR-ODT
Generic Entry Date for ADZENYS XR-ODT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ADZENYS XR-ODT

Identify potential brand extensions & 505(b)(2) entrants

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

See all ADZENYS XR-ODT clinical trials

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   Get Started Free   Get Started Free Y   Get Started Free
Neos Theraps ADZENYS XR-ODT amphetamine TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 204326-005 Jan 27, 2016 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Neos Theraps ADZENYS XR-ODT amphetamine TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 204326-006 Jan 27, 2016 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Neos Theraps ADZENYS XR-ODT amphetamine TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 204326-002 Jan 27, 2016 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Neos Theraps ADZENYS XR-ODT amphetamine TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 204326-001 Jan 27, 2016 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Neos Theraps ADZENYS XR-ODT amphetamine TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 204326-003 Jan 27, 2016 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Neos Theraps ADZENYS XR-ODT amphetamine TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 204326-005 Jan 27, 2016 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
>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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