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Last Updated: November 20, 2019

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ADZENYS XR-ODT Drug Profile

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When do Adzenys Xr-odt patents expire, and what generic alternatives are available?

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. Two suppliers are listed for this compound. Additional details are available on the amphetamine profile page.

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

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Recent Litigation for ADZENYS XR-ODT

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District Court Litigation
Case NameDate
Neos Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc.2017-12-13

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Pharmacology for ADZENYS XR-ODT
Synonyms for ADZENYS XR-ODT
24 HR Amphetamine aspartate
ADDERALL 10
ADDERALL 12.5
ADDERALL 15
ADDERALL 20
ADDERALL 30
ADDERALL 5
ADDERALL 7.5
ADDERALL XR 10
ADDERALL XR 15
ADDERALL XR 20
ADDERALL XR 25
ADDERALL XR 30
ADDERALL XR 5
Amphetamine aspartate mixture with amphetamine sulfate, dextroamphetamine saccharate and dextroamphetamine sulfate
Dextroamphetamine sulfate mixture with dextroamphetamine saccharate and amphetamine aspartate monohydrate and amphetamine sulfate
S900000010
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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