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Last Updated: September 26, 2022

Details for New Drug Application (NDA): 204325


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NDA 204325 describes ADZENYS ER, which is a drug marketed by Neos Theraps Inc and is included in one NDA. There are three patents protecting this drug. Additional details are available on the ADZENYS ER profile page.

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.
Summary for 204325
Tradename:ADZENYS ER
Applicant:Neos Theraps Inc
Ingredient:amphetamine
Patents:3
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 204325
Generic Entry Date for 204325*:
Constraining patent/regulatory exclusivity:
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.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SUSPENSION, EXTENDED RELEASE;ORALStrengthEQ 1.25MG BASE/ML
Approval Date:Sep 15, 2017TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Jun 28, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Jun 28, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Jun 28, 2032Product Flag?YSubstance Flag?Delist Request?

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Harvard Business School
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