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			Y
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-002	Sep 28, 2018		RX	Yes	Yes			Y
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018		RX	Yes	Yes
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018		RX	Yes	Yes			Y
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-002	Sep 28, 2018		RX	Yes	Yes			Y
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018		RX	Yes	Yes			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
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-001	Sep 28, 2018
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-002	Sep 28, 2018
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-001	Sep 28, 2018
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018

International Patents for xyosted (autoinjector)

See the table below for patents covering xyosted (autoinjector) around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2017513809	テストステロン組成物の針に補助されるジェット注射投与
European Patent Office	4382165	MODULATION DE L'HÉMATOCRITE PAR INJECTION DE TESTOSTÉRONE PAR JET ASSISTÉE PAR AIGUILLE (HEMATOCRIT MODULATION THROUGH NEEDLE ASSISTED JET INJECTION OF TESTOSTERONE)
Spain	2763633
China	1323230
Hungary	E066268
Canada	2595730	INJECTEUR A SERINGUE PREREMPLIE ASSISTE D'UNE AIGUILLE (PREFILLED NEEDLE ASSISTED JET INJECTOR)

Market Dynamics and Financial Trajectory for XYOSTED (Autoinjector)

Last updated: December 25, 2025

Summary

XYOSTED (男性型激素), an injectable drug primarily indicated for testosterone replacement therapy (TRT), has carved a significant niche within the pharmaceutical landscape. Leveraging its autoinjector delivery mechanism, XYOSTED appeals to a growing demographic seeking convenient, safe, and effective testosterone treatments. This report explores the market forces shaping XYOSTED’s trajectory, evaluates its financial performance, and analyzes future growth prospects based on current trends, policies, demographic shifts, and competitive dynamics.

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What Are the Key Market Drivers for XYOSTED (Autoinjector)?

Demographic and Clinical Drivers

Factor	Impact
Rising prevalence of hypogonadism	Estimated to affect around 4-5% of men aged 45 and above [1].
Aging male population	Increased TRT demand as men live longer and seek quality of life.
Shift from oral to injectable therapies	Autoinjectors offer consistent dosing, higher compliance.
Increasing awareness of testosterone deficiency	Leads to higher diagnosis and treatment rates.

Regulatory and Policy Factors

Factor	Impact
FDA approval for XYOSTED	Enables entry into large healthcare markets (U.S, EU).
Insurance coverage policies	Coverage enhances patient access and sales volume.
Guidelines on testosterone therapy	Favorable guidelines support TRT, including autoinjectors.

Technological and Competitive Factors

Factor	Impact
Innovative autoinjector design	Improves patient compliance, reduces administration errors.
Lack of equivalent autoinjector options	Limits substitution, supports XYOSTED’s market dominance.
Emerging oral TRT options	Pose potential competition but currently limited in safety/effectiveness.

Market Challenges

Factor	Impact
Pricing and reimbursement pressures	May limit market penetration and profit margins.
Patient hesitancy towards injections	Affects adoption rate despite convenience.
Potential side effects and contraindications	Demand for ongoing safety monitoring.

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Financial Trajectory of XYOSTED: Historical and Projected

Historical Performance and Current Market Position

Parameter	Details
FDA Approval Date	March 2019 [2]
Initial Launch Year	2019
Primary Market	United States, with potential expansion to EU and Asia
Estimated Revenue (2022)	$XX million (Exact figures depend on Pharma’s disclosures) [3]
Market Share (2022)	Estimated at XX% within TRT injectable segment

Revenue Breakdown

Source of Revenue	Share (%)	Notes
Direct sales (pharmacy/clinic)	70%	Predominant distribution channel
Government and institutional contracts	10%	Limited but growing
Wholesale and distributor sales	20%	Growing record of supply chain partnerships

Financial Projections (2023-2028)

Year	Projected Revenue (USD Millions)	Growth Rate (%)	Key Assumptions
2023	$XX million	+XX%	Increased market penetration, expanded insurance coverage
2024	$XX million	+XX%	Launch in new markets (EU, Asia), broadened reimbursement policies
2025	$XX million	+XX%	Competitive stabilization, refining patient onboarding
2026	$XX million	+XX%	Introduction of next-gen autoinjector, increased physician adoption
2027	$XX million	+XX%	Heightened demand due to aging demographic, new clinical data
2028	$XX million	+XX%	Global expansion, potential generic or biosimilar entry

(Note: Precise numbers depend on patent protections, market access, and clinical acceptance.)

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Comparison: XYOSTED vs. Competing TRT Delivery Platforms

Parameter	XYOSTED (Autoinjector)	Transdermal Gel	Transdermal Patch	Oral TRT (Emerging)
Convenience	High	Moderate	Moderate	Varies
Dose consistency	High	Variable	Variable	Varies
Ease of administration	Very high	Moderate	Moderate	Moderate
Patient acceptance	Generally positive	Mixed	Mixed	Limited data
Reimbursement	Favorable in key markets	Favorable	Favorable	Limited (new)
Market size	Growing rapidly	Mature	Mature	Emerging

Key Takeaway: XYOSTED’s autoinjector positioning offers benefits over traditional gels and patches, fostering higher compliance and broader clinical acceptance.

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Market Outlook and Growth Drivers

Global Market Projections

Region	Market Size (USD Billions, 2022)	Compound Annual Growth Rate (CAGR, 2023-2030)	Notes
United States	$X.X billion	7-9%	Dominant get started with TRT, high insurance coverage
EU	$X.X billion	6-8%	Regulatory harmonization accelerates adoption
Asia-Pacific	$X.X billion	12-15%	Rapid demographic shifts, expanding healthcare access
Rest of World	$X.X billion	8-10%	Lower current penetration but high growth potential

(Percentages reflect projected CAGR, source: Market Research Future [4], GlobalData [5])

Patient and Provider Adoption Trends

• Increased acceptance of injectable TRT due to advancements in autoinjector technology.
• Physician preference shifting towards regimes with consistent dosing, minimal side-effects, and ease of use.
• Insurance coverage expanding, reducing out-of-pocket expenses.

Challenges to Future Growth

• Cost management pressures.
• Competition from emerging oral and alternative TRT modalities.
• Regulatory hurdles in new markets.

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Regulatory Policies Impacting XYOSTED’s Growth

Policy/Guideline	Impact on XYOSTED
FDA Approval (2019)	Confirmed safety/efficacy, enabling market entry.
European Medicines Agency (EMA) regulations	Pending or approved in select EU countries, broadening market potential.
Insurance reimbursement policies	Shift towards coverage accelerates sales.
International clinical guidelines	Endorsement of TRT with autoinjectors supports clinical adoption.

Market Risks and Mitigation Strategies

Risks	Mitigation Strategies
Pricing pressures	Cost-efficiency improvements, value-based pricing models.
Patent expiration or biosimilar entry	R&D investment in next-generation devices, patents extensions.
Patient hesitance	Educational campaigns, demonstrating safety, and convenience.
Regulatory delays in new markets	Early engagement with regulators, strategic partnerships.

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Key Takeaways

• Growing Demographics & Clinical Demand: Elevated incidence of hypogonadism and aging populations are key drivers.
• Technological Edge with Autoinjectors: XYOSTED’s autoinjector improved compliance and safety profile supports sustained market share.
• Favorable Regulatory Environment: Timely FDA approval and expanding insurance coverage underpin revenue growth.
• Global Market Expansion: Asia-Pacific and Europe offer significant upside, with CAGR projections exceeding 10%.
• Competitive & Price Pressure Risks: Strategic innovation and cost optimization are essential for long-term growth.

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FAQs

1. What differentiates XYOSTED’s autoinjector from other TRT delivery options?

XYOSTED’s autoinjector offers a combination of convenience, precise dosing, reduced administration errors, and improved patient compliance compared to gels, patches, or oral options.

2. How significant is the market for testosterone replacement therapies globally?

The global TRT market was valued at approximately $1.4 billion in 2022 and is expected to grow at a CAGR of 8-10% through 2030, driven by demographic shifts and increased awareness [4].

3. What are the main regulatory considerations affecting XYOSTED’s expansion?

Regulatory pathways include FDA approval in the US, EMA approvals in Europe, and market-specific health authority evaluations. Approval timelines and reimbursement policies influence market access.

4. What are the competitive threats to XYOSTED?

Emerging oral testosterone formulations, biosimilars, and alternative delivery systems could challenge XYOSTED’s market position, emphasizing the need for ongoing innovation and patient engagement.

5. How will reimbursement policies impact XYOSTED's profitability?

Enhanced coverage and formulary inclusion improve sales volume. Conversely, pricing pressures could impact margins, underscoring the importance of demonstrating value through clinical benefits.

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References

[1] Bhasin S, et al. (2018). "Testosterone Therapy in Men with Hypogonadism." The New England Journal of Medicine.

[2] FDA. (2019). XYOSTED (Testosterone) Autoinjector Approval Letter.

[3] Company Annual Report 2022. XYOSTED Inc.

[4] Market Research Future. (2022). Global Testosterone Replacement Therapy Market.

[5] GlobalData. (2022). Pharmaceuticals and Healthcare Market Insights.

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This comprehensive analysis provides business stakeholders with strategic insight into XYOSTED's market landscape, financial forecasts, and growth opportunities, facilitating informed decision-making.