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
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 |


DrugPatentWatch® Estimated Generic Entry Opportunity Date for ADZENYS XR-ODT
Generic Entry Date for ADZENYS XR-ODT*:
Constraining patent/regulatory exclusivity:
NDA:
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 |
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
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 | 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.
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 |