Last reviewed 2026-04-20 · How we verify

Xyosted (Autoinjector) (testosterone enantate)

Endo · FDA-approved active Quality 35/100

Xyosted (Autoinjector) (generic name: testosterone enantate) is a Androgen drug developed by Endo. It is currently FDA-approved (first approved 1953) for Deficiency of testosterone biosynthesis, Delayed puberty, Hormone receptor positive malignant neoplasm of breast.

Xyosted (testosterone enantate) is an autoinjector marketed by Endo for the treatment of testosterone deficiency, positioning it in a segment with several established and emerging competitors. A key strength of Xyosted is its unique autoinjector delivery system, which may offer convenience and improve patient adherence compared to other formulations. The primary risk is the competitive landscape, particularly from off-patent drugs like bicalutamide and danazol, which could erode market share due to their lower cost and availability.

At a glance

Generic name	testosterone enantate
Sponsor	Endo
Drug class	Androgen
Target	Androgen receptor
Therapeutic area	Oncology
Phase	FDA-approved
First approval	1953

Approved indications

Deficiency of testosterone biosynthesis
Delayed puberty
Hormone receptor positive malignant neoplasm of breast
Klinefelter's syndrome, XXY
LHRH Deficiency
Male hypogonadism
Menopausal flushing
Undescended testicle

Common side effects

No common side effects on file.

Key clinical trials

Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism (PHASE3)

Patents

Patent	Expiry	Type

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
FDA label	Mechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.gov	Trial enrolment, design, endpoints, results
FDA Orange Book	Patents + exclusivity

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Xyosted (Autoinjector) CI brief — competitive landscape report
Xyosted (Autoinjector) updates RSS · CI watch RSS
Endo portfolio CI

Frequently asked questions about Xyosted (Autoinjector)

What is Xyosted (Autoinjector)?

Xyosted (Autoinjector) (testosterone enantate) is a Androgen drug developed by Endo, indicated for Deficiency of testosterone biosynthesis, Delayed puberty, Hormone receptor positive malignant neoplasm of breast.

What is Xyosted (Autoinjector) used for?

Xyosted (Autoinjector) is indicated for Deficiency of testosterone biosynthesis, Delayed puberty, Hormone receptor positive malignant neoplasm of breast, Klinefelter's syndrome, XXY, LHRH Deficiency.

Who makes Xyosted (Autoinjector)?

Xyosted (Autoinjector) is developed and marketed by Endo (see full Endo pipeline at /company/endo).

What is the generic name of Xyosted (Autoinjector)?

testosterone enantate is the generic (nonproprietary) name of Xyosted (Autoinjector).

What drug class is Xyosted (Autoinjector) in?

Xyosted (Autoinjector) belongs to the Androgen class. See all Androgen drugs at /class/androgen.

When was Xyosted (Autoinjector) approved?

Xyosted (Autoinjector) was first approved on 1953.

What development phase is Xyosted (Autoinjector) in?

Xyosted (Autoinjector) is FDA-approved (marketed).

What does Xyosted (Autoinjector) target?

Xyosted (Autoinjector) targets Androgen receptor and is a Androgen.

Drug class: All Androgen drugs
Target: All drugs targeting Androgen receptor
Manufacturer: Endo — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Deficiency of testosterone biosynthesis
Indication: Drugs for Delayed puberty
Indication: Drugs for Hormone receptor positive malignant neoplasm of breast