Adzenys Xr-odt is a drug owned by Neos Therapeutics. It is protected by 5 US drug patents filed from 2016 to 2024. Out of these, 4 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 28, 2032. Details of Adzenys Xr-odt's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8709491 | Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles |
Jun, 2032
(5 years from now) | Active |
| US9017731 | Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles |
Jun, 2032
(5 years from now) | Active |
| US9265737 | Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles |
Jun, 2032
(5 years from now) | Active |
| US9839619 | Method for treating ADD or ADHD comprising administering amphetamine complexed with ion-exchange resin particles |
Jun, 2032
(5 years from now) | Active |
| US8840924 | Compositions and methods of making rapidly dissolving ionically masked formulations |
Apr, 2026
(6 months ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Adzenys Xr-odt's patents.
Latest Legal Activities on Adzenys Xr-odt's Patents
Given below is the list of recent legal activities going on the following patents of Adzenys Xr-odt.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Yr, Small Entity | 25 Feb, 2026 | US8840924 (Litigated) |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 29 Jul, 2025 | US8709491 (Litigated) |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 01 May, 2025 | US9839619 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 21 Jul, 2023 | US9265737 (Litigated) |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 21 Oct, 2022 | US9017731 (Litigated) |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 20 Jan, 2022 | US8840924 (Litigated) |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 21 Oct, 2021 | US8709491 (Litigated) |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 03 Jun, 2021 | US9839619 |
| Email Notification | 14 Apr, 2020 | US9265737 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) | 14 Apr, 2020 | US9265737 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but
Adzenys Xr-odt is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Adzenys Xr-odt's family patents as well as insights into
ongoing legal events
on those patents.
Adzenys Xr-odt's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Adzenys Xr-odt:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| Ketamine for Methamphetamine Use Disorder | University of Texas Southwestern Medical Center | NA | ACTIVE NOT RECRUITING
(Sep 1, 2026) | PHASE2 |
| Psilocybin for Methamphetamine Use Disorder | Peter Hendricks | NA | NOT YET RECRUITING
(Sep 1, 2026) | PHASE2 |
| Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder | University of Texas Southwestern Medical Center | NA | NOT YET RECRUITING
(Sep 1, 2026) | PHASE2 |
| MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder | Stephen Robert Marder | NA | RECRUITING
(Aug 1, 2026) | PHASE2 |
| Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder | Virginia Commonwealth University | NA | COMPLETED
(Aug 1, 2026) | PHASE2 |
| MDMA-assisted Massed Prolonged Exposure for PTSD | Healing Breakthrough | NA | ACTIVE NOT RECRUITING
(Aug 1, 2026) | PHASE3 |
| Ketamine-Assisted Recovery for Methamphetamine Use Disorder & HIV | Nicky Mehtani, MD, MPH | NA | COMPLETED
(Aug 1, 2026) | PHASE2 |
| Methamphetamine Isomer Pharmacology in Humans | University of Wisconsin, Madison | NA | NOT YET RECRUITING
(Aug 1, 2026) | PHASE1 |
| Methylphenidate and Response to Alcohol Cues | University of Florida | NA | NOT YET RECRUITING
(Aug 1, 2026) | PHASE2 |
| An Open-Label Tirzepatide Trial for Comorbid Obesity and Stimulant Use Disorder | University of Texas Southwestern Medical Center | NA | ENROLLING BY INVITATION
(Aug 1, 2026) | PHASE2 |
| Psilocybin Therapy for Methamphetamine Use Disorder and HIV | Nicky Mehtani, MD, MPH | NA | NOT YET RECRUITING
(Aug 1, 2026) | PHASE2 |
| Preliminary Effectiveness of Individual and Group MDMA-assisted Therapy for Israeli Veterans With PTSD and Moral Injury. | HaEmek Medical Center, Israel | NA | RECRUITING
(Jul 1, 2026) | PHASE2 |
| MDMA Plus Exposure Therapy for PTSD | Emory University | NA | ENROLLING BY INVITATION
(Jul 1, 2026) | PHASE2 |
| Tolerability of MDMA in Schizophrenia | Anya Bershad, MD, PhD | NA | RECRUITING
(Jul 1, 2026) | PHASE1, PHASE2 |
| Mirtazapine for the Treatment of Methamphetamine Use in Opioid Use Disorder Patients Receiving Medication Assisted Treatment | Washington State University | NA | RECRUITING
(Jul 1, 2026) | PHASE2 |
| A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine | Clear Scientific, Inc. | NA | RECRUITING
(Jul 1, 2026) | PHASE2 |
| Decreasing Risk of Psychosis by Sulforaphane (DROPS Trial) | Shanghai Jiao Tong University School of Medicine | NA | ACTIVE NOT RECRUITING
(Jun 1, 2026) | PHASE3 |
| Naltrexone for Overdose Prevention | University of California, San Francisco | NA | RECRUITING
(Jun 1, 2026) | PHASE2, PHASE3 |
| Glutide for Ending Methamphetamine | San Francisco Department of Public Health | NA | RECRUITING
(Jun 1, 2026) | PHASE2 |
| Semaglutide for Treatment of People With Methamphetamine Use Disorder: the SHIFT Study | Kirby Institute | NA | NOT YET RECRUITING
(Jun 1, 2026) | PHASE2 |
| Effects of Stimulant Medications in PTSD | University of Chicago | NA | NOT YET RECRUITING
(Jun 1, 2026) | PHASE1 |
| Study of the Safety and Feasibility of Psilocybin in Adults With Methamphetamine Use Disorder | University of Wisconsin, Madison | NA | TERMINATED
(May 1, 2026) | PHASE1 |
| Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder | Parnassia Addiction Research Centre | NA | RECRUITING
(May 1, 2026) | PHASE2 |
| Comparative Acute Effects of R-MDMA and S-MDMA in Healthy Participants | University Hospital, Basel, Switzerland | NA | COMPLETED
(May 1, 2026) | PHASE1 |
| MDMA-Assisted Massed Exposure Therapy for PTSD | Emory University | NA | RECRUITING
(May 1, 2026) | PHASE2 |
| A Study to Evaluate the Abuse Potential of EB-1020 Immediate-Release in Healthy Recreational Stimulant Users | Otsuka Pharmaceutical Development & Commercialization, Inc. | NA | COMPLETED
(Apr 1, 2026) | PHASE1 |
| Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder | Portland VA Research Foundation, Inc | NA | ACTIVE NOT RECRUITING
(Apr 1, 2026) | PHASE1, PHASE2 |
| MDMA for Co-occurring PTSD and OUD After Childbirth | University of New Mexico | NA | RECRUITING
(Mar 1, 2026) | PHASE2 |
| Effects of Ketone Supplement and Alcohol on Brain Metabolism | University of Pennsylvania | NA | RECRUITING
(Mar 1, 2026) | PHASE2, PHASE3 |
Generic Launch
Generic Release Date:
Adzenys Xr-odt's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 28, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Adzenys Xr-odt Generic API suppliers:
Amphetamine is the generic name for the brand Adzenys Xr-odt. 1 company has already filed for the generic of Adzenys Xr-odt. Check out the entire list of companies who have already received approval for Adzenys Xr-odt's generic
How can I launch a generic of Adzenys Xr-odt before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Adzenys Xr-odt's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Adzenys Xr-odt's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Adzenys Xr-odt -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 10 May, 2016 | 28 Jan, 2032 | Deferred | 22 Jun, 2023 | Less |
Alternative Brands for Adzenys Xr-odt
There are several other brand drugs using the same active ingredient (Amphetamine) as Adzenys Xr-odt. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |||||||
|---|---|---|---|---|---|---|---|---|
| Azurity |
| |||||||
| Neos Theraps Inc |
| |||||||
| Noven Pharms Inc |
| |||||||
| Takeda Pharms Usa |
| |||||||
| Teva Womens |
| |||||||
| Tris Pharma Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Amphetamine, Adzenys Xr-odt's active ingredient. Check the complete list of approved generic manufacturers for Adzenys Xr-odt
About Adzenys Xr-odt
Adzenys Xr-Odt is a drug owned by Neos Therapeutics. Adzenys Xr-Odt uses Amphetamine as an active ingredient. Adzenys Xr-Odt was launched by Neos in 2016.
Approval Date:
Adzenys Xr-odt was approved by FDA for market use on 27 January, 2016.
Active Ingredient:
Adzenys Xr-odt uses Amphetamine as the active ingredient. Check out other Drugs and Companies using Amphetamine ingredient
Dosage:
Adzenys Xr-odt is available in tablet, orally disintegrating, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 18.8MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | Prescription | ORAL |
| EQ 15.7MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | Prescription | ORAL |
| EQ 3.1MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | Prescription | ORAL |
| EQ 6.3MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | Prescription | ORAL |
| EQ 12.5MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | Prescription | ORAL |
| EQ 9.4MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | Prescription | ORAL |