Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Boehringer Ingelheim
Colorcon
Medtronic
Dow

Last Updated: August 19, 2022

ADZENYS XR-ODT Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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

< Available with Subscription >

  Try it Free

Drug patent expirations by year for ADZENYS XR-ODT
Drug Prices for ADZENYS XR-ODT

See drug prices for ADZENYS XR-ODT

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

SponsorPhase
Duke UniversityPhase 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
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 M√ČTHODES 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
AstraZeneca
Baxter
Merck
Johnson and Johnson
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.