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Last Updated: October 12, 2024

ADZENYS ER Drug Patent Profile


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Which patents cover Adzenys Er, and what generic alternatives are available?

Adzenys Er 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 ADZENYS ER is amphetamine. There are fifty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amphetamine profile page.

DrugPatentWatch® Generic Entry Outlook for Adzenys Er

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 ER
Drug Prices for ADZENYS ER

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Recent Clinical Trials for ADZENYS ER

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

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

See all ADZENYS ER clinical trials

US Patents and Regulatory Information for ADZENYS ER

ADZENYS ER is protected by three US patents.

Patents protecting ADZENYS ER

Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 ADZENYS ER amphetamine SUSPENSION, EXTENDED RELEASE;ORAL 204325-001 Sep 15, 2017 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Neos Theraps Inc ADZENYS ER amphetamine SUSPENSION, EXTENDED RELEASE;ORAL 204325-001 Sep 15, 2017 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Neos Theraps Inc ADZENYS ER amphetamine SUSPENSION, EXTENDED RELEASE;ORAL 204325-001 Sep 15, 2017 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 ADZENYS ER

When does loss-of-exclusivity occur for ADZENYS ER?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

European Patent Office

Patent: 26066
Patent: FORMES POSOLOGIQUES POUR ADMINISTRATION ORALE ET MÉTHODES DE TRAITEMENT LES UTILISANT (DOSAGE FORMS FOR ORAL ADMINISTRATION AND METHODS OF TREATMENT USING THE SAME)
Estimated Expiration: ⤷  Sign Up

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 ADZENYS ER around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 2726066 FORMES POSOLOGIQUES POUR ADMINISTRATION ORALE ET MÉTHODES DE TRAITEMENT LES UTILISANT (DOSAGE FORMS FOR ORAL ADMINISTRATION AND METHODS OF TREATMENT USING THE SAME) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2013003622 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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