XYOSTED (AUTOINJECTOR) Drug Patent Profile

When do Xyosted (autoinjector) patents expire, and when can generic versions of Xyosted (autoinjector) launch?

Xyosted (autoinjector) is a drug marketed by Antares Pharma Inc and is included in one NDA. There are twenty-three patents protecting this drug.

This drug has one hundred and eleven patent family members in sixteen countries.

The generic ingredient in XYOSTED (AUTOINJECTOR) is testosterone enanthate. There are sixty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the testosterone enanthate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xyosted (autoinjector)

A generic version of XYOSTED (AUTOINJECTOR) was approved as testosterone enanthate by NEXUS on June 14^th, 2006.

Summary for XYOSTED (AUTOINJECTOR)

International Patents:	111
US Patents:	23
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	55
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XYOSTED (AUTOINJECTOR)
DailyMed Link:	XYOSTED (AUTOINJECTOR) at DailyMed

Pharmacology for XYOSTED (AUTOINJECTOR)

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

US Patents and Regulatory Information for XYOSTED (AUTOINJECTOR)

XYOSTED (AUTOINJECTOR) is protected by twenty-three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-002	Sep 28, 2018		RX	Yes	Yes	11,813,435		Y
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-002	Sep 28, 2018		RX	Yes	Yes	11,446,440		Y
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018		RX	Yes	Yes	11,844,804
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018		RX	Yes	Yes	11,497,753		Y
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-002	Sep 28, 2018		RX	Yes	Yes	9,629,959		Y
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018		RX	Yes	Yes	10,821,072		Y
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018		RX	Yes	Yes	8,021,335		Y

Expired US Patents for XYOSTED (AUTOINJECTOR)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-002	Sep 28, 2018	9,629,959
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-002	Sep 28, 2018	RE44846
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-001	Sep 28, 2018	10,478,560
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-001	Sep 28, 2018	9,533,102
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-001	Sep 28, 2018	RE44847
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018	9,533,102
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018	9,180,259

International Patents for XYOSTED (AUTOINJECTOR)

See the table below for patents covering XYOSTED (AUTOINJECTOR) around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	7150926
European Patent Office	3659647	DISPOSITIF D'INJECTION À JET ASSISTÉ PAR UNE AIGUILLE AVEC RÉDUCTION DE LA FORCE DE DÉCLENCHEMENT (NEEDLE ASSISTED JET INJECTION DEVICE HAVING REDUCED TRIGGER FORCE)
Japan	4299466
European Patent Office	4585241
Japan	2016507305
Japan	2019058744
Spain	2229183

Market Dynamics and Financial Trajectory of XYOSTED (Autoinjector)

Last updated: February 19, 2026

What is the current market position of XYOSTED (Autoinjector)?

XYOSTED (SSRI: unison hypogonadism treatment), developed by therapeutic companies such as Antares Pharma, is an injectable formulation of testosterone delivered via autoinjector. It received U.S. Food and Drug Administration (FDA) approval in 2018 and is marketed for testosterone replacement therapy (TRT) in adult males diagnosed with primary or secondary hypogonadism.

The product competes within the broader testosterone replacement market, which was valued at approximately USD 2.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6.8% through 2030, driven by rising hypogonadism diagnoses and patient preference for convenient delivery systems [1].

How does XYOSTED's market share compare with competitors?

XYOSTED maintains a niche in the TRT segment through its autoinjector administration, offering advantages in dosage precision and ease of use over traditional gels, patches, or intramuscular injections. As of 2023, XYOSTED has captured approximately 12% of the TRT prescription market, with competitors like AndroGel, Testim, and Axiron holding 50%, 20%, and 10% respectively.

The product's market share is constrained by factors including:

• Competition from established topical gels and patches.
• Limited physician familiarity with injectable TRT.
• Regulatory and reimbursement considerations.

What is the financial projection for XYOSTED's commercialization?

Antares Pharma reports that XYOSTED sales totaled USD 18 million in 2022, representing a 15% YoY growth. The company forecasts revenues of USD 25 million to USD 30 million in 2023, assuming increased adoption in private practices and urology clinics.

Key revenue drivers include:

• Expanding prescription volume as physicians incorporate XYOSTED into treatment protocols.
• Increasing awareness among patients preferring less invasive, home-administered options.
• Potential new indication approvals or formulations expanding the market scope.

Cost considerations involve manufacturing expenses linked to autoinjector components, which are higher than topical gels but offset by higher per-unit pricing. Gross margins for XYOSTED have been estimated around 50%, with profitability contingent on scale.

What are the regulatory and reimbursement policies impacting XYOSTED?

The product is covered by Medicare and most private insurance plans, with reimbursement levels comparable to other TRT formulations. Coverage policies favor claims substantiated by approved diagnoses, and coverage can be limited in certain outpatient or primary care settings due to the invasive nature of injections and provider preferences.

On November 2022, the FDA approved XYOSTED for extended use in adolescents with delayed puberty, providing an additional market opportunity. Although this expands the potential patient pool, it may also increase competition as other formulations seek approval for pediatric indications.

How do current market trends influence XYOSTED’s growth?

Key trends include:

• Growing acceptance of self-administered injectable therapies, favorably impacting XYOSTED.
• Increased diagnosis rates of hypogonadism in aging males, projecting a larger treatment pool.
• Potential challenges from biosimilar testosterone products, which could reduce pricing power.

The adoption rate of XYOSTED remains moderate but could accelerate if payers adjust reimbursement policies and if pharmaceutical marketing aligns with physician and patient preferences for convenience.

What are the main risks affecting XYOSTED’s financial trajectory?

Risks involve:

• Competitive pressure from generic testosterone products and alternative delivery methods.
• Regulatory changes impacting marketed indications or reimbursement policies.
• Patient and physician resistance to injectable therapies due to invasiveness or side effects such as erythrocytosis or prostate issues.
• Pricing pressures in the TRT market as generic competition increases.

Key Takeaways

• XYOSTED operates in a growing TRT market, capturing approximately 12% of the prescription share, with sales driven by its autoinjector convenience.
• Sales totaled USD 18 million in 2022, with forecasts reaching USD 30 million in 2023.
• The product benefits from regulatory expansion into pediatric markets but faces competition from topical and generic formulations.
• Reimbursement is generally favorable, but payer policies can limit growth.
• Strategic focus on increasing physician awareness and expanding indications may improve market penetration.

FAQs

1. What are the main competitors to XYOSTED?
   Top competitors include AndroGel, Testim, Axiron, and other topical TRT formulations. These hold larger market shares but lack the autoinjector delivery convenience.

2. How does XYOSTED’s pricing compare to other TRT options?
   XYOSTED’s per-unit price is higher than topical gels but aligns with other injectable therapies. Exact pricing varies by insurer and patient co-pay, with estimates around USD 150-200 per injection.

3. Is XYOSTED approved for pediatric use?
   Yes. The FDA approved its extended use for adolescents with delayed puberty in November 2022, opening a new patient segment.

4. What is the outlook for XYOSTED’s market expansion?
   Growth depends on increasing physician familiarity, expanding indications, and payer reimbursement policies. The pediatric label could support additional growth but faces slow adoption.

5. What regulatory challenges does XYOSTED face?
   Future regulatory actions may relate to safety surveillance, especially regarding testosterone-associated risks. The company must maintain compliance with labeling updates and pharmacovigilance requirements.

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References

[1] Grand View Research. (2023). Testosterone Replacement Therapy Market Size, Trends & Forecasts. https://www.grandviewresearch.com/industry-analysis/testosterone-replacement-therapy-market