Amphetamine Patent Expiration

Amphetamine was first introduced by Neos Therapeutics in its drug Adzenys Xr-Odt on Jan 27, 2016. Another drug containing Amphetamine is Adzenys Er. 3 different companies have introduced drugs containing Amphetamine.


Amphetamine Patents

Given below is the list of patents protecting Amphetamine, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Adzenys Er US8709491 Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles Jun 28, 2032 Neos Theraps Inc
Adzenys Er US9017731 Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles Jun 28, 2032 Neos Theraps Inc
Adzenys Er US9265737 Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles Jun 28, 2032 Neos Theraps Inc
Adzenys Xr-odt US8709491 Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles Jun 28, 2032 Neos Theraps
Adzenys Xr-odt US9017731 Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles Jun 28, 2032 Neos Theraps
Adzenys Xr-odt US9265737 Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles Jun 28, 2032 Neos Theraps
Adzenys Xr-odt US9839619 Method for treating ADD or ADHD comprising administering amphetamine complexed with ion-exchange resin particles Jun 28, 2032 Neos Theraps
Adzenys Xr-odt US8840924 Compositions and methods of making rapidly dissolving ionically masked formulations Apr 09, 2026

(Expired)

Neos Theraps



Amphetamine's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Amphetamine:

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
Clinical Trials
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


Amphetamine Generic API Manufacturers

Several generic applications have been filed for Amphetamine.

Given below is the list of companies who have filed for Amphetamine generic, along with the locations of their manufacturing plants worldwide.