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Last Updated: June 19, 2021

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ADZENYS ER Drug 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. Three suppliers are 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.

Indicators of Generic Entry

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Summary for ADZENYS ER
Drug patent expirations by year for ADZENYS ER
Drug Prices for ADZENYS ER

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

See all ADZENYS ER clinical trials

Pharmacology for ADZENYS ER

US Patents and Regulatory Information for ADZENYS ER

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 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Neos Theraps Inc ADZENYS ER amphetamine SUSPENSION, EXTENDED RELEASE;ORAL 204325-001 Sep 15, 2017 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Neos Theraps Inc ADZENYS ER amphetamine SUSPENSION, EXTENDED RELEASE;ORAL 204325-001 Sep 15, 2017 RX Yes Yes   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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