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Last Updated: September 26, 2022

ADZENYS ER Drug Patent Profile


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When do Adzenys Er patents expire, 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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 28, 2032. 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 ER
Drug Prices for ADZENYS ER

See drug prices for ADZENYS ER

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ADZENYS ER
Generic Entry Date for ADZENYS ER*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SUSPENSION, 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 ER

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 ER clinical trials

US Patents and Regulatory Information for ADZENYS ER

ADZENYS ER is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ADZENYS ER is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Neos Theraps Inc ADZENYS ER amphetamine SUSPENSION, EXTENDED RELEASE;ORAL 204325-001 Sep 15, 2017 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Neos Theraps Inc ADZENYS ER amphetamine SUSPENSION, EXTENDED RELEASE;ORAL 204325-001 Sep 15, 2017 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

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 M√ČTHODES DE TRAITEMENT LES UTILISANT (DOSAGE FORMS FOR ORAL ADMINISTRATION AND METHODS OF TREATMENT USING THE SAME) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2013003622 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.