Testosterone products by country: Canada, US, UK and Australia

Testosterone products by country differ sharply. On 14 September 2026 Canada listed 13 marketed drug identification numbers across four forms, the United States carried the widest range including pellets and an auto-injector, the United Kingdom had long-acting injections and gels but no oral product since 2008, and Australia alone registered a testosterone cream for men.

Key takeaways

• Canada had 13 marketed human testosterone drug identification numbers on 14 September 2026, covering 1 percent gel, nasal gel, oral undecanoate capsules and two short-acting intramuscular injections.
• The United States carries every form on this page except the mixed-ester injection, including Testopel pellets (ANDA 080911), the Xyosted auto-injector (NDA 209863) and a 2 percent topical solution.
• The United Kingdom list comes from the Electronic Medicines Compendium and is a UK list only, because none of these products is centrally authorized by the European Medicines Agency.
• Australia is the only one of the four with a registered testosterone cream for men, AndroForte 5 at 5 percent w/v, ARTG 123764, funded as PBS item 10378F at a dispensed price of $105.62 with a $25.00 patient charge.
• The patch and the buccal system have now disappeared from all four markets, although both were available in most of them within the last decade.

Everything below describes what a regulator has registered, not what anyone should take. The clinical evidence behind these products applies to men with confirmed low testosterone, and it does not apply to men whose levels are normal. The diagnostic standard is set out in how low testosterone is diagnosed in Canada. What testing your own case needs is a decision for your doctor or nurse practitioner.

How do testosterone products compare by country?

By form rather than by brand, because brand names differ across the four markets while the dosage form is what a reader is actually asking about. Every cell below was verified in the four national regulator databases on 14 September 2026, each named in the method note at the end.

Only one form, intramuscular enanthate, is registered in all four countries. The differences between the esters themselves are set out in testosterone esters explained.

What testosterone products are available in Canada?

Thirteen marketed drug identification numbers, verified in Health Canada’s Drug Product Database on 14 September 2026: six 1 percent gel presentations across three brands (AndroGel DINs 02245345, 02245346 and 02249499, Testim 02280248, Taro-Testosterone Gel 02463792 and 02463806), one nasal gel at 4.5 percent (Natesto, 02450550), four oral undecanoate capsules (Jatenzo 02563770, 02563789 and 02563797, Taro-Testosterone 40 mg 02421186) and two intramuscular injections (Taro cypionate 100 mg/mL 02496003 and Hikma Canada enanthate 200 mg/mL 02536315).

Canada is the only one of the four where a long-acting testosterone undecanoate injection has never been authorized, and every Canadian undecanoate DIN is an oral capsule. The full Canadian picture, including the products cancelled in 2025 and the four approved but not yet marketed, is in testosterone products available in Canada.

What testosterone products are available in the United States?

The widest range of the four, verified in Drugs@FDA on 14 September 2026. Prescription-status products include AndroGel 1 percent (NDA 021015) and 1.62 percent (NDA 022309), Testim (NDA 021454), Vogelxo (NDA 204399), Natesto (NDA 205488), Jatenzo (NDA 206089), Tlando (NDA 208088), Kyzatrex (NDA 213953, the 150 mg and 200 mg strengths, with the 100 mg discontinued), Aveed (NDA 022219), Xyosted (NDA 209863), Azmiro cypionate (NDA 216318), Depo-Testosterone (ANDA 085635) and Testopel pellets (ANDA 080911), alongside many generic cypionate, enanthate, gel and 2 percent topical solution approvals.

Three of those forms exist nowhere else among the four countries: the subcutaneous auto-injector, implantable pellets and the 2 percent topical solution. The evidence behind pellets and the nasal route is covered in nasal, buccal and pellet testosterone.

Why does Aveed have a REMS?

Because of two specific risks named on its label. Aveed “is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the AVEED REMS Program,” and the label attributes that restriction to the risks of serious pulmonary oil microembolism reactions and of anaphylaxis. The program requires that the patient be observed in the healthcare setting for 30 minutes after every injection.

Aveed is the only testosterone product among the four countries with a REMS. No equivalent restriction attaches to the long-acting undecanoate injections registered in the United Kingdom or Australia.

What has the United States discontinued?

The Androderm patch in all four strengths (NDA 020489), Testoderm, the Striant buccal system (NDA 021543), and the Fortesta and Axiron brands, although generics of both remain. The Orange Book entries for the Androderm 2 mg and 4 mg strengths carry the Federal Register determination that the product “was not discontinued or withdrawn for safety or effectiveness reasons,” so the patch left commercially, not on a safety finding.

What is available in the United Kingdom, and why is there no European list?

Because there is no single European register for these products, and none of them is centrally authorized by the European Medicines Agency. Every one holds a national marketing authorization, so an equivalent product may be authorized, discontinued or absent in Germany, France, Spain or Ireland, often under a different brand name. The list below is a United Kingdom list, representative of one European market rather than of Europe.

Marketed per the Electronic Medicines Compendium on 14 September 2026: Nebido testosterone undecanoate 1000 mg/4 mL (PL 21727/0099) plus four generics from Roxadin, Orifarm, Laboratorios Farmalan and Teva; Sustanon 250 mixed esters (PL 39699/0059); Testosterone Enantate 250 mg/mL from Alliance (PL 16853/0116); and five gels, Testogel 16.2 mg/g pump, Testogel 40.5 mg sachet, Tostran 2 percent, Testavan 2 percent and Irisel 16.2 mg/g, first authorized 18 June 2026. The Testogel 50 mg sachet is flagged discontinued.

The United Kingdom has no oral testosterone: Restandol Testocaps was discontinued on 25 February 2008. It has no patch, no cream for men, no buccal product, no nasal gel and no pellets.

What testosterone products are available in Australia?

Long-acting injection, short-acting enanthate, mixed esters, gel and cream, verified in the Australian Register of Therapeutic Goods on 14 September 2026. The long-acting group is Reandron 1000 testosterone undecanoate (ARTG 106946 ampoule, 213942 vial) plus Rejunon 1000, Reanmed, Testosterone ADVZ 1000, Testosterone SUN and Gonadron, all at 1000 mg/4 mL. Primoteston Depot enanthate 250 mg/mL is ARTG 10707 and Sustanon 250 is ARTG 14521 and 190717. Testogel 1 percent is registered as a pump (ARTG 227563) and as sachets (ARTG 96131).

Australia has no oral testosterone, because Andriol Testocaps was cancelled, and no patch, because Androderm was cancelled. It has no pellets: the 100 mg implant was cancelled under section 30(1)(c) of the Therapeutic Goods Act, a sponsor request with no published safety reason. It also has no nasal gel, no buccal product and no short-acting cypionate.

The one product Australia has that the others do not

AndroForte 5, a testosterone cream at 5 percent w/v, ARTG 123764. It is the only registered testosterone cream for men among the four countries. It is funded through the Pharmaceutical Benefits Scheme as item 10378F, at a dispensed price of $105.62 with a patient charge of $25.00. Within the same scheme, PBS item 10205D, the long-acting undecanoate injection, has a dispensed price of $92.91 and the same $25.00 patient charge. The Testogel items are 10380H (pump) and 8830R (sachets).

Those are Australian figures under an Australian subsidy scheme and do not transfer to any other country. How creams and gels behave is covered in testosterone gels and creams.

Which forms exist in only one country, and which in none?

Four forms are registered in exactly one market. Three are American: the subcutaneous auto-injector, implantable pellets and the 2 percent topical solution. The fourth is Australian: the testosterone cream for men.

Two forms are now registered in none of the four. The patch and the buccal system have disappeared from all four markets, although both existed in most of them within the last decade, which is why older articles still describe them as choices. In Canada the last patch DIN was cancelled on 14 April 2022, and in the United States the Striant buccal system (NDA 021543) is listed as discontinued.

Why are some products missing, with no reason on record?

Because regulators publish decisions, not always explanations, and in three cases the published record does not say. These are unknowns, not gaps to fill with a plausible story.

• Why Canada has never authorized the long-acting testosterone undecanoate injection. No public reason on record. Neither Nebido nor Aveed has ever held a Canadian authorization and no Health Canada document explaining that was found.
• Why no testosterone cream for men exists outside Australia. No public reason on record. A cream is registered and subsidized in Australia and no equivalent exists in Canada, the United States or the United Kingdom.
• Why the original oral Andriol formulation was never approved in the United States. No public reason on record. The modern oral undecanoate products were approved in the US decades later on their own applications, a separate matter covered in oral testosterone evidence.

What the evidence does not show

• None of these registers shows supply. A product in marketed or registered status can still be back-ordered, and the database will not say so.
• A wider product list is not evidence of better outcomes. No trial has randomized patients to one national formulary against another.
• Registration status is not a safety ranking. The Aveed REMS is a US restriction on one product, and its absence elsewhere does not mean another product is safer.
• The Australian PBS figures are dispensed prices and patient charges within a subsidy scheme on 14 September 2026. They are not the cost of treatment in any other country.
• No public reason could be found for three of the absences above, so the honest answer in each case is unknown.

How this list was verified, and where the gaps are

Four regulator databases were queried on 14 September 2026: Health Canada’s Drug Product Database, the US Drugs@FDA and Orange Book, the UK Electronic Medicines Compendium, and the Australian Register of Therapeutic Goods with the Pharmaceutical Benefits Scheme schedule.

The Australian Register search interface blocked automated enumeration, so every Australian product named here was confirmed from its own public summary record and a very recently registered product could be missing. The FDA’s bulk REMS data files returned a 404 error, so the Aveed REMS description above comes from the approved product label rather than from the REMS database. The MHRA products database returned no data to automated retrieval, so the UK list comes from the Electronic Medicines Compendium, which carries only products whose licence holder has uploaded a summary of product characteristics.

None of these gaps affects a product that is listed, only what might be missing, which is why every entry here carries an identifier and a date. Preparations made by a pharmacy appear in none of the four registers, as covered in compounded testosterone in Canada, and what each regulator has said about testosterone is covered in testosterone rules in Canada, the US, Europe and Australia.

Frequently asked questions

Which country has the most testosterone products?

The United States, verified in Drugs@FDA on 14 September 2026. It is the only one of the four countries with implantable pellets (Testopel, ANDA 080911), a subcutaneous auto-injector (Xyosted, NDA 209863) and a 2 percent topical solution, and it also carries gels, oral undecanoate capsules, nasal gel and both short-acting injectable esters. The only form it lacks is the mixed-ester injection.

Why can Canadians not get long-acting testosterone undecanoate injection?

Because it has never been authorized in Canada. Nebido and Aveed, the long-acting castor oil depot products used in the United Kingdom, Australia and the United States, have never held a Canadian authorization, and every testosterone undecanoate drug identification number in Canada is an oral capsule. No public reason for the absence appears in Health Canada’s published record, so the accurate answer is that it is unknown.

Is testosterone cream available anywhere?

Yes, in Australia only among these four countries. AndroForte 5, a testosterone cream at 5 percent w/v, is registered as ARTG 123764 and subsidized as Pharmaceutical Benefits Scheme item 10378F at a dispensed price of $105.62 with a $25.00 patient charge. No testosterone cream for men is registered in Canada, the United States or the United Kingdom, checked on 14 September 2026.

What is the Aveed REMS and the 30 minute observation?

Aveed (NDA 022219) is the only testosterone product among these four countries supplied under a Risk Evaluation and Mitigation Strategy. Its US label states the product is available only through that restricted program because of the risks of serious pulmonary oil microembolism reactions and anaphylaxis, and requires the patient to be observed in the healthcare setting for 30 minutes after every injection.

Why is this a UK list rather than a European one?

Because there is no single European register for testosterone products and none of them is centrally authorized by the European Medicines Agency. Every product holds a national marketing authorization, so an equivalent medicine may be authorized, discontinued or absent in Germany, France, Spain or Ireland, frequently under a different brand name. The United Kingdom list is treated here as representative of one European market, not of Europe.

Which testosterone form is available in all four countries?

Only one: the intramuscular enanthate injection. It is registered in Canada (Testosterone Enanthate Injection USP 200 mg/mL, DIN 02536315), in the United States as multiple approvals, in the United Kingdom (Testosterone Enantate 250 mg/mL, PL 16853/0116) and in Australia (Primoteston Depot 250 mg/mL, ARTG 10707). Every other form on the comparison table is missing from at least one country.

References

1. Health Canada. Drug Product Database. Retrieved 14 September 2026. https://health-products.canada.ca/dpd-bdpp/search/
2. US Food and Drug Administration. Drugs@FDA and the Orange Book. Retrieved 14 September 2026. https://www.accessdata.fda.gov/scripts/cder/daf/
3. US National Library of Medicine. DailyMed label for AVEED (testosterone undecanoate injection), NDA 022219, including the AVEED REMS Program statement. Retrieved 14 September 2026. URL not recorded in the source review.
4. Datapharm. Electronic Medicines Compendium. Retrieved 14 September 2026. https://www.medicines.org.uk/emc
5. Therapeutic Goods Administration, Australia. Australian Register of Therapeutic Goods. Retrieved 14 September 2026. https://www.tga.gov.au/resources/artg
6. Pharmaceutical Benefits Scheme, Australia. Schedule of Pharmaceutical Benefits, items 10205D, 10378F, 10380H and 8830R. Retrieved 14 September 2026. https://www.pbs.gov.au
7. Wittert G, et al. 2016. An open-label, phase 2, single centre, randomized, crossover design bioequivalence study of AndroForte 5 testosterone cream and Testogel 1% testosterone gel in hypogonadal men: study LP101. Andrology. PMID 26754331. DOI: https://doi.org/10.1111/andr.12129
8. Pastuszak AW, et al. 2020. Occurrence of Pulmonary Oil Microembolism After Testosterone Undecanoate Injection: A Postmarketing Safety Analysis. Sexual Medicine. PMID 32184081. DOI: https://doi.org/10.1016/j.esxm.2020.01.009
9. Government of Canada. Controlled Drugs and Substances Act, Schedule IV. Retrieved 14 September 2026. https://laws-lois.justice.gc.ca/eng/acts/c-38.8/page-12.html

This page is educational information, not medical advice. Testosterone is a prescription medication and a controlled substance in Canada. Talk to your doctor or pharmacist about your own situation.