Grünenthal licenses exclusive Canadian rights to testosterone replacement therapy Nebido® to Apotex

madman · 2026-02-07T09:57:20-0600

Great news for Canadians!

The first long-acting injectable esterifed T formulation will be available soon!

* Apotex Inc. ("Apotex"), the largest Canadian-based pharmaceutical company, today announced they have entered into a licensing agreement whereby Apotex will have the exclusive Canadian rights to Nebido® (testosterone undecanoate), a long-acting injectable therapy indicated for the treatment of male hypogonadism (testosterone deficiency).[1]

Apotex licenses exclusive Canadian rights to testosterone replacement therapy Nebido® from Grünenthal

Aachen, Germany & Toronto, Canada, February 5, 2026 – Grünenthal, a global leader in pain management and related diseases, and Apotex Inc. ("Apotex"), the largest Canadian-based pharmaceutical company, today announced they have entered into a licensing agreement whereby Apotex will have the exclusive Canadian rights to Nebido® (testosterone undecanoate), a long-acting injectable therapy indicated for the treatment of male hypogonadism (testosterone deficiency).[1]

Under the agreement, Searchlight Pharma, Apotex's branded medicine division, will pursue marketing authorisation and will market and distribute the product in Canada upon regulatory approval. Grünenthal will receive an upfront payment, regulatory milestone payments, and a margin on the sales.

This agreement deepens the existing partnership between Grünenthal and Apotex and strengthens their shared commitment to expanding Canadian patients' access to important therapies.

"We are delighted to expand our partnership with Apotex and further strengthen the global presence of the brand," says Jan Adams, Chief Commercial Officer (CCO) at Grünenthal. "Through this agreement, we are providing a valuable and well-established brand that can benefit countless people living with testosterone deficiency in Canada."

"This marks an important step in Apotex's mission to broaden access to innovative medicines and advance our purpose as a Force for Health," says Mark Nawacki, President, Searchlight Pharma. "Nebido® addresses a recognised need in men's health and represents our first entry into testosterone therapy – opening a meaningful new therapeutic area for Apotex while strengthening our branded portfolio and expanding our presence in specialty care."

Grünenthal acquired the global rights for the brand in 2022 as part of its growth strategy. Since 2017, the company has invested over €2 billion in successful mergers and acquisitions (M&A) transactions, diversifying its portfolio, enhancing its profitability, and driving business growth. Grünenthal continues to expand the footprint of these brands and to create synergies throughout Grünenthal's infrastructure, including manufacturing, supply, logistics, and commercial activities.

https://www.bayer.com/sites/default/files/NEBIDO_EN_PIL.pdf

madman · 2026-02-07T10:06:41-0600

Thread 'Use of oral and injectable testosterone undecanoate TRT'

Mar 31, 2023

Safety Aspects and Rational Use of Testosterone Undecanoate in the Treatment of Testosterone Deficiency: Clinical Insights (2023)
Katherine Campbell, Akhil Muthigi, Armin Ghomeshi, Kyle Schuppe, Max D Sandler, Ranjith Ramasamy

Abstract

Testosterone deficiency is diagnosed by a serum total testosterone level below 300 ng/dL in combination with symptoms such as decreased energy and libido. These symptoms can be ameliorated by restoring serum testosterone to the physiologic range with testosterone therapy (TT). There are numerous forms of testosterone therapy, such as...

Injectable Testosterone Undecanoate Formulations

Aveed
-History and Development
-Efficacy
-Dosing
-Adverse Effects

Nebido
-History and Development
-Efficacy
-Dosing
-Adverse Effects

Patient Selection for Injectable Testosterone Undecanoate

Intramuscular injections of testosterone have been the most commonly prescribed form of TT since their development in the 1930s.64 IM formulations of TT remain the most cost-effective and most frequently covered by insurance, making them an ideal option for those wishing for cost-effective treatment. IM injections of T often require dose optimization based on body habitus and individual metabolism; therefore, dosing may vary and should be guided by an individual’s serologic and symptomatic response. Though IM injections are commonly used, and generally safe, this formulation may not be a suitable option for patients who are averse to self-injecting the medication. Additionally, those with physical or cognitive impairment that prevents them from drawing up testosterone from a small vial and then injecting it may not be candidates for IM TT.

Thread 'Pharmacological management of TD in men current advances and future directions'

Jul 27, 2024

ABSTRACT

Introduction

Testosterone deficiency (TD) is relatively common in aging men, affecting around 2% of the general population. Testosterone replacement therapy (TRT) represents the most common medical approach for subjects who are not interested in fathering.

Areas covered

This review summarizes advances in TRT, including approved or non-approved pharmacological options to overcome TD. When possible, a meta-analytic approach was applied to minimize subjective and biased interpretations of the available data.

Expert opinion

During the last...

3.3. New intramuscular formulation for TRT

Although TU intramuscular formulations have been available worldwide for more than 20 years and are approved in more than 100 countries and marketed in more than 80 parts of the world, including Europe (Nebido, originally by Bayer AG, Kaiser Wilhelm-Allee 1 51,373 Leverkusen, Germany [45]), in the USA injectable TU was FDA-approved only in 2014 with the brandname AVEED (Endo Pharmaceuticals Solutions Inc.). The main difference between Nebido and AVEED is in their single-use vial dose, i.e. 1000 mg in 4 mL for the former and 750 mg in 3 mL for the latter. At variance with Nebido, following the first intramuscular injection of 3 mL of AVEED (750 mg), a second 3 mL dose isinjected four weeks later, and then 3 mL is injected every ten weeks thereafter. The approval of AVEED is based on data from an 84-week Phase 3 trial of hypogonadal men in the USA. The men enrolled in the study had an average age of 54 years and a serum total T level of less than 10.4 nmol/l. In the Phase 3 study, AVEED increased mean serum T levels, maintaining them for up to 10 weeks at a steady state (between weeks 14–24) [46]. Clinical experience in the USA with TU 750 mg provides evidence for good patient satisfaction and persistence with treatment, together with a favorable safety profile [47]. However, its prescription is available only through a Risk Evaluation and Mitigation Strategies (REMS) program. In addition, AVEED carries a black box warning for serious pulmonary oil microembolism(POME) reactions (the urge to cough, dyspnea, throat tightening,chest pain, dizziness, syncope) and episodes of anaphylaxis. However, of the 633 individual case safety reports in the Endo Pharmaceuticals Inc. safety database, 28 spontaneously reported adverse events were classified as POME, for a yearly spontaneously reported adverse event per injection rate of <0.1% [48]. Most (21/22) events resolved, and of those with a resolution time reported, most (13/17) were resolved in less than 30 minutes (32).More than 60% (13/21) of patients required no medical intervention [48]. In a meta-analysis of injectable TU preparations, it was found that in either controlled or uncontrolled trials, injectable TU was associated with a reduction of fat mass and HbA1c and an improvement of erectile function, without an increased risk of prostate cancer or severe CV events [45]. A recent Australian RCT[49] - the T4DM trial enrolling more than 1.000 men aged 50 years with prediabetes or newly diagnosed type 2 diabetes mellitus (T2DM) with a mild TD (total T < 14 nmol/L) – reported that a two-year treatment with TU 1000 mg, along with a lifestyle program, reduced the likelihood of T2DM diagnosis by 40% compared to placebo. This effect was accompanied by a decrease in fasting serum glucose and was associated with favorable changes in body composition, hand grip strength,bone mineral density, skeletal microarchitecture, and sexual function [49,50].Interestingly, a recent network meta-analysis showed that the rate of hematocrit increase upon injectable TUis lower than with other injectable preparations and similar to that associated with gels, patches, or oral TU preparations [51].

Post in thread 'Pulmonary Oil Micro Embolism Research - Intro'

Dec 22, 2025

DiegoMarinDO said:
Hello everyone,

My name is Diego Marin D.O. and I am a Pulmonologist and Intensivist.

I am working on a research project with a medical resident based around a patient that I saw that I diagnosed with POME. We found that this appears grossly under-reported in the medical literature and we are writing a case report with review of the literature. As part of this, I thought it would be a great addition to gauge a "real world" incidence of coughing, coughing fits, shortness of breath, or other respiratory symptoms associated with testosterone injections or other anabolics. What better...

madman · 2026-02-07T10:23:01-0600

Thread 'State-of-the-Art Lecture: Updates on testosterone replacement therapy CUA 2025'

Aug 3, 2025

Nelson's house.....you know where it's at!

Conclusions

madman · 2026-02-07T10:24:02-0600

Thread 'Testosterone Products in Canada - (oral, nasal, transdermal, injectable)'

Oct 12, 2024

Big pharma transdermal T patch Androderm manufactured by Allergan Inc. was discontinued back in 2018!

Big pharma brand name Andriol (oral TU) manufactured by Merck was also discontinued back in 2018 and more recently 2024 our beloved Delatestryl (testosterone enanthate) manufactured by Valeant has been discontinued.

The only oral TU available is the generic PMS-Testosterone and Taro-Testosterone capsules.

Come 2025 we may have the option to use the newer versions of oral TU Kyzatrex or Tlando which are available in the US as Marius Pharmaceuticals and Verity Pharmaceuticals are...