ADZENYS XR-ODT Drug Patent Profile

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When do Adzenys Xr-odt patents expire, and when can generic versions of Adzenys Xr-odt launch?

Adzenys Xr-odt is a drug marketed by Neos Theraps and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has two patent family members in two countries.

The generic ingredient in ADZENYS XR-ODT 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 Xr-odt

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 9, 2026. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases 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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Summary for ADZENYS XR-ODT

International Patents:	2
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ADZENYS XR-ODT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADZENYS XR-ODT
What excipients (inactive ingredients) are in ADZENYS XR-ODT?	ADZENYS XR-ODT excipients list
DailyMed Link:	ADZENYS XR-ODT at DailyMed

Drug patent expirations by year for ADZENYS XR-ODT

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for ADZENYS XR-ODT

Generic Entry Date for ADZENYS XR-ODT^: See Plans and Pricing* Constraining patent/regulatory exclusivity: See Plans and Pricing NDA: 204326 Dosage: TABLET, ORALLY DISINTEGRATING, 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 XR-ODT

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

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

See all ADZENYS XR-ODT clinical trials

Pharmacology for ADZENYS XR-ODT

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

Paragraph IV (Patent) Challenges for ADZENYS XR-ODT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADZENYS XR-ODT	Extended-release Orally Disintegrating Tablets	amphetamine	3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg	204326	1	2016-05-10

US Patents and Regulatory Information for ADZENYS XR-ODT

ADZENYS XR-ODT is protected by four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ADZENYS XR-ODT 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 XR-ODT

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

Compositions and methods of making rapidly dissolving ionically masked formulations
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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-001	Jan 27, 2016		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-005	Jan 27, 2016		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-006	Jan 27, 2016		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-002	Jan 27, 2016		RX	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 XR-ODT

See the table below for patents covering ADZENYS XR-ODT around the world.

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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)	See Plans and Pricing
World Intellectual Property Organization (WIPO)	2013003622		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration