Testoderm Patent Expiration

Testoderm is a drug owned by Alza Corp. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 15, 2016. Details of Testoderm's patents and their expiration are given in the table below.

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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).
US5840327 Transdermal drug delivery device having enhanced adhesion
Aug, 2016

(10 years ago)

Expired

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US patents provide insights into the exclusivity only within the United States, but Testoderm 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 Testoderm's family patents as well as insights into ongoing legal events on those patents.

Testoderm's Family Patents


Family Patents

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Clinical Trials

Recent Clinical Trials on Testoderm:

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
Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor National Cancer Institute (NCI) NA RECRUITING
(Sep 15, 2026)
PHASE2
Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism Neurocrine UK Limited NA COMPLETED
(Sep 1, 2026)
PHASE1
High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers VA Office of Research and Development NA RECRUITING
(Sep 1, 2026)
PHASE2
A Study to Learn How Safe the Study Treatment Actinium-225-macropa-pelgifatamab (BAY3546828) is, How it Affects the Body, How it Moves Into, Through and Out of the Body, and About Its Anticancer Activity in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC) Bayer NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1
Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC Yale University NA RECRUITING
(Sep 1, 2026)
PHASE2
A Study of BMS986365 in Combination With Degarelix in People With Prostate Cancer Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering From Gender Dysphoria Assistance Publique - Hôpitaux de Paris NA RECRUITING
(Aug 1, 2026)
PHASE3
Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer Dongkook Pharmaceutical Co., Ltd. NA COMPLETED
(Aug 1, 2026)
PHASE3
Locoregional Administration of Genetically Engineered Cells (EGFR/IL13Rα2 Pool-CAR T Cells) for the Treatment of Recurrent or Progressive High-Grade Gliomas City of Hope Medical Center NA RECRUITING
(Aug 1, 2026)
PHASE1
Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency Seattle Institute for Biomedical and Clinical Research NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism Brigham and Women's Hospital NA RECRUITING
(Jul 1, 2026)
PHASE2
First-in-human Study of 225Ac-PSMA-Trillium (BAY 3563254) in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC) Bayer NA RECRUITING
(Jul 1, 2026)
PHASE1
PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate Cancer Affidea Nu-med Center of Oncological DIagnostics and Therapy NA RECRUITING
(Jul 1, 2026)
PHASE2, PHASE3
Adjuvant Rezvilutamide Monotherapy for High-Risk Prostate Cancer After Radical Prostatectomy The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School NA RECRUITING
(Jul 1, 2026)
PHASE2
ADT De-escalation in Selected High-Risk Prostate Cancer Patients (ADaPPt Trial) a GROUQ Led PCS Study (PCS XIV) Dr. Tamim Niazi NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE3
Clinical Trial to Observe the Effects of Tamoxifen on Testosterone Recovery in Medically Castrated Prostate Cancer Patients University Health Network, Toronto NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
Escalating Cycle 1 Dose of Lu-177-PSMA-617 for the Treatment of Metastatic Castration Resistant Prostate Cancer University of Michigan Rogel Cancer Center NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE1
Product Transference Study of Testagen™ TDS®-Testosterone Transdermal Delivery Solutions Corp NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone Emory University NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1
Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC H. Lee Moffitt Cancer Center and Research Institute NA RECRUITING
(May 1, 2026)
PHASE2
Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial) Brigham and Women's Hospital NA COMPLETED
(Apr 1, 2026)
PHASE2
Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-Based Anti-Cytomegalovirus (CMV) Vaccine (Triplex®) National Institute of Allergy and Infectious Diseases (NIAID) NA COMPLETED
(Apr 1, 2026)
PHASE2
Testosterone Treatment in Men With Chronic Kidney Disease St. Louis University NA RECRUITING
(Apr 1, 2026)
PHASE2
Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency Rune Skovgaard Rasmussen NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
A Randomized Controlled Trial of Combined Bu Shen Yi Qi Decoction and Dehydroepiandrosterone (DHEA) for the Treatment of Ovarian Function Decline Jiangxi University of Traditional Chinese Medicine NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone? Norwegian School of Sport Sciences NA COMPLETED
(Mar 1, 2026)
PHASE2, PHASE3
A Study Investigating the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Teverelix DP, a Gonadotropin-releasing Hormone (GnRH) Antagonist, in Patients With Advanced Prostate Cancer Antev Ltd. NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE2




Generic Launch

Generic Release Date:

Testoderm's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 15, 2016 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Testoderm Generic API suppliers:

Testosterone is the generic name for the brand Testoderm. 14 different companies have already filed for the generic of Testoderm, with Actavis Labs Ut Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Testoderm's generic

Alternative Brands for Testoderm

There are several other brand drugs using the same active ingredient (Testosterone) as Testoderm. 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
Acerus
Natesto
Alza
Testoderm Tts
Antares Pharma Inc
Xyosted (autoinjector)
Auxilium Pharms Llc
Striant
Azurity
Azmiro
Besins Hlthcare
Androgel
Eli Lilly And Co
Axiron
Endo Operations
Aveed
Fortesta
Testim
Marius
Kyzatrex
Tolmar
Jatenzo
Upsher Smith Labs
Vogelxo
Verity
Tlando


Apart from brand drugs containing the same ingredient, some generics have also been filed for Testosterone, Testoderm's active ingredient. Check the complete list of approved generic manufacturers for Testoderm





About Testoderm

Testoderm is a drug owned by Alza Corp. Testoderm uses Testosterone as an active ingredient. Testoderm was launched by Alza in 1993.

Approval Date:

Testoderm was approved by FDA for market use on 12 October, 1993.

Active Ingredient:

Testoderm uses Testosterone as the active ingredient. Check out other Drugs and Companies using Testosterone ingredient

Dosage:

Testoderm is available in film, extended release form for transdermal use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
4MG/24HR FILM, EXTENDED RELEASE Discontinued TRANSDERMAL
6MG/24HR FILM, EXTENDED RELEASE Discontinued TRANSDERMAL