ADZENYS ER Drug Patent Profile

When do Adzenys Er patents expire, and when can generic versions of Adzenys Er launch?

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

Summary for ADZENYS ER

International Patents:	2
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	1
Patent Applications:	6,542
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ADZENYS ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADZENYS ER
What excipients (inactive ingredients) are in ADZENYS ER?	ADZENYS ER excipients list
DailyMed Link:	ADZENYS ER at DailyMed

See drug prices for ADZENYS ER

Recent Clinical Trials for ADZENYS ER

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

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

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

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

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)
World Intellectual Property Organization (WIPO)	2013003622