Testosterone Patent Expiration

Testosterone was first introduced by Alza Corp in its drug Testoderm on Oct 12, 1993. Other drugs containing Testosterone are Androderm, Striant, Natesto, Testoderm Tts, Testim, Fortesta, Testosterone, Vogelxo, Androgel, Axiron. 23 different companies have introduced drugs containing Testosterone.


Testosterone Patents

Given below is the list of patents protecting Testosterone, 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
Natesto US11090312 Methods of treating hypogonadism with transnasal testerosterone bio-adhesive gel formulations in male with allergic rhinitis, and methods for preventing an allergic rhinitis event Mar 17, 2034 Acerus
Natesto US11744838 Methods Of Treating Hypogonadism With Transnasal Testosterone Bio-Adhesive Gel Formulations In Male With Allergic Rhinitis, And Methods For Preventing An Allergic Rhinitis Event Mar 17, 2034 Acerus
Vogelxo US8785426 Testosterone gel compositions and related methods Feb 11, 2034 Upsher Smith Labs
Vogelxo US9295675 Testosterone gel compositions and related methods Feb 11, 2034 Upsher Smith Labs
Vogelxo US9622340 Flexible circuit board and method for manufacturing same Feb 11, 2034 Upsher Smith Labs
Vogelxo US9662340 Testosterone gel compositions and related methods Feb 11, 2034 Upsher Smith Labs
Axiron US8435944 Method and composition for transdermal drug delivery Sep 27, 2027 Eli Lilly And Co
Axiron US8419307 Spreading implement Feb 26, 2027 Eli Lilly And Co
Axiron US8807861 Spreading implement Feb 26, 2027 Eli Lilly And Co
Axiron US9289586 Spreading implement Feb 26, 2027 Eli Lilly And Co
Androgel US8446138 Stability compensation circuit and DC-DC converter including the same Oct 12, 2026 Besins Hlthcare
Androgel US8466136 Testosterone gel and method of use Oct 12, 2026 Besins Hlthcare
Androgel US8466137 Testosterone gel and method of use Oct 12, 2026 Besins Hlthcare
Androgel US8466138 Testosterone gel and method of use Oct 12, 2026 Besins Hlthcare
Androgel US8486925 Testosterone gel and method of use Oct 12, 2026 Besins Hlthcare
Androgel US8729057 Testosterone gel and method of use Oct 12, 2026 Besins Hlthcare
Androgel US8741881 Testosterone gel and method of use Oct 12, 2026 Besins Hlthcare
Androgel US8754070 Testosterone gel and method of use Oct 12, 2026 Besins Hlthcare
Androgel US8759329 Testosterone gel and method of use Oct 12, 2026 Besins Hlthcare
Axiron US8993520 Method and composition for transdermal drug delivery Jun 02, 2026

(Expired)

Eli Lilly And Co
Axiron US9180194 Method and composition for transdermal drug delivery Jun 02, 2026

(Expired)

Eli Lilly And Co
Testim US7320968 Pharmaceutical composition Jan 18, 2025

(Expired)

Endo Operations
Natesto US8574622 Controlled release delivery system for nasal applications Feb 04, 2024

(Expired)

Acerus
Natesto US8784869 Controlled release delivery system for nasal applications and methods of treatment Feb 04, 2024

(Expired)

Acerus
Natesto US8784882 Controlled release delivery system for nasal applications and method of treatment Feb 04, 2024

(Expired)

Acerus
Natesto US8877230 Controlled release delivery system for nasal applications Feb 04, 2024

(Expired)

Acerus
Axiron US8784878 Transdermal delivery rate control using amorphous pharmaceutical compositions Jul 13, 2023

(Expired)

Eli Lilly And Co
Testim US7608605 Pharmaceutical composition Apr 21, 2023

(Expired)

Endo Operations
Testim US7608606 Pharmaceutical composition Apr 21, 2023

(Expired)

Endo Operations
Testim US7608607 Pharmaceutical composition Apr 21, 2023

(Expired)

Endo Operations
Testim US7608608 Pharmaceutical composition Apr 21, 2023

(Expired)

Endo Operations
Testim US7608609 Pharmaceutical composition Apr 21, 2023

(Expired)

Endo Operations
Testim US7608610 Pharmaceutical composition Apr 21, 2023

(Expired)

Endo Operations
Testim US7935690 Pharmaceutical composition Apr 21, 2023

(Expired)

Endo Operations
Testim US8063029 Pharmaceutical composition Apr 21, 2023

(Expired)

Endo Operations
Testim US8178518 Pharmaceutical composition Apr 21, 2023

(Expired)

Endo Operations
Androgel US6503894

(Pediatric)

Pharmaceutical composition and method for treating hypogonadism Mar 02, 2021

(Expired)

Besins Hlthcare
Androgel US9125816

(Pediatric)

Pharmaceutical composition and method for treating hypogonadism Mar 02, 2021

(Expired)

Besins Hlthcare
Androgel US9132089

(Pediatric)

Pharmaceutical composition and method for treating hypogonadism Mar 02, 2021

(Expired)

Besins Hlthcare
Androgel US6503894

(Pediatric)

Pharmaceutical composition and method for treating hypogonadism Mar 01, 2021

(Expired)

Besins Hlthcare
Androgel US6503894 Pharmaceutical composition and method for treating hypogonadism Aug 30, 2020

(Expired)

Besins Hlthcare
Androgel US9125816 Pharmaceutical composition and method for treating hypogonadism Aug 30, 2020

(Expired)

Besins Hlthcare
Androgel US9132089 Pharmaceutical composition and method for treating hypogonadism Aug 30, 2020

(Expired)

Besins Hlthcare
Testoderm Tts US6348210 Methods for transdermal drug administration Nov 10, 2019

(Expired)

Alza
Striant US6248358 Bioadhesive progressive hydration tablets and methods of making and using the same Aug 23, 2019

(Expired)

Auxilium Pharms Llc
Fortesta US6319913 Penetration enhancing and irritation reducing systems Nov 09, 2018

(Expired)

Endo Operations
Fortesta US6579865 Penetration enhancing and irritation reducing systems Nov 09, 2018

(Expired)

Endo Operations
Axiron US6299900 Dermal penetration enhancers and drug delivery systems involving same Feb 19, 2017

(Expired)

Eli Lilly And Co
Axiron US6818226 Dermal penetration enhancers and drug delivery systems involving same Feb 19, 2017

(Expired)

Eli Lilly And Co
Axiron US6923983 Transdermal delivery of hormones Feb 19, 2017

(Expired)

Eli Lilly And Co
Axiron US8071075 Dermal penetration enhancers and drug delivery systems involving the same Feb 19, 2017

(Expired)

Eli Lilly And Co
Testoderm US5840327 Transdermal drug delivery device having enhanced adhesion Aug 15, 2016

(Expired)

Alza



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 Testosterone's patents.

Given below is the list recent legal activities going on the following patents of Testosterone.

Activity Date Patent Number
Patent litigations
Maintenance Fee Reminder Mailed 09 Mar, 2026 US8785426
Payment of Maintenance Fee, 8th Year, Large Entity 14 Sep, 2024 US9622340
Expire Patent 17 Jun, 2024 US8178518(Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 12 Jun, 2024 US9662340
Maintenance Fee Reminder Mailed 01 Jan, 2024 US8178518(Litigated)
Expire Patent 25 Dec, 2023 US8063029
Maintenance Fee Reminder Mailed 10 Jul, 2023 US8063029
Expire Patent 05 Jun, 2023 US7935690(Litigated)
Maintenance Fee Reminder Mailed 19 Dec, 2022 US7935690(Litigated)
Expire Patent 29 Nov, 2021 US7608607(Litigated)


Testosterone's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Testosterone:

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


Testosterone Generic API Manufacturers

Several generic applications have been filed for Testosterone. The first generic version for Testosterone was by Endo Operations Ltd and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Encube Ethicals Private Ltd and was approved on Jul 11, 2024.

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