XYOSTED (AUTOINJECTOR) Drug Patent Profile

Which patents cover Xyosted (autoinjector), 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 three patent family members in fourteen 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:	103
US Patents:	23
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	55
Patent Applications:	2,688
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	209863-002	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	11,844,804
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018		RX	Yes	Yes	11,497,753		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	RE44846
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-001	Sep 28, 2018	RE44846
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018	RE44847
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-001	Sep 28, 2018	RE44847
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-002	Sep 28, 2018	RE44847

International Patents for XYOSTED (AUTOINJECTOR)

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

Country	Patent Number	Title	Estimated Expiration
Australia	5470499
Japan	6640907
Japan	2017523858	注射装置で使用するためのシリンジ緩衝器
Spain	2763633
World Intellectual Property Organization (WIPO)	2010108116

Market Dynamics and Financial Trajectory for XYOSTED (Autoinjector)

Introduction to XYOSTED

XYOSTED is a groundbreaking autoinjector developed for the subcutaneous delivery of testosterone replacement therapy. It is the first and only weekly autoinjector of its kind, providing a convenient and efficient treatment option for patients requiring testosterone therapy.

Market Drivers

The market for XYOSTED and similar autoinjectors is driven by several key factors:

Increasing Demand for Targeted Therapies

The rise in targeted therapies, particularly for chronic conditions such as hypogonadism, is a significant driver. XYOSTED's weekly dosing regimen offers a more convenient alternative to traditional daily or bi-weekly injections, enhancing patient compliance and satisfaction[4].

Regulatory Approvals

Regulatory approvals play a crucial role in the growth of the autoinjector market. Recent approvals and partnerships, such as the agreement between Antares Pharma and Lunatus Global for the distribution of XYOSTED in the UAE and Saudi Arabia, have expanded the market reach of these products[1][4].

COVID-19 Impact

The COVID-19 pandemic has accelerated the demand for home-based treatments, including autoinjectors. The convenience and safety of self-administration at home have contributed to the increased adoption of autoinjectors like XYOSTED[4].

Financial Performance of XYOSTED

Revenue Growth

XYOSTED has demonstrated strong revenue growth. In 2023, it achieved $100 million in sales, marking a significant milestone for the product. This growth is expected to continue, driven by increasing demand and expanded distribution agreements[3].

Partnerships and Collaborations

The success of XYOSTED is also attributed to strategic partnerships. For instance, Halozyme's ENHANZE technology, which enables rapid and large-volume subcutaneous delivery, has been instrumental in the product's development and market acceptance. Partnerships with companies like Antares Pharma and Lunatus Global have further enhanced the product's market penetration[3][5].

Halozyme's Financial Outlook and XYOSTED's Role

Halozyme, the company behind the ENHANZE technology used in XYOSTED, has reported robust financial results that reflect the product's impact:

Total Revenue

Halozyme's total revenue has seen significant growth, with a 34% year-over-year increase in the third quarter of 2024, reaching $290 million. This growth is largely driven by increases in royalty revenue, collaboration revenue, and product sales from XYOSTED[5].

Royalty Revenue

Royalty revenue from products like XYOSTED has been a key contributor to Halozyme's financial performance. For 2024, the company expects royalty revenue to grow by 23% to 26% over 2023, reaching $550 million to $565 million[5].

Adjusted EBITDA and EPS

Halozyme's adjusted EBITDA and non-GAAP diluted EPS have also shown substantial growth. The adjusted EBITDA is expected to increase by 40% to 47% over 2023, reaching $595 million to $625 million, while non-GAAP diluted EPS is projected to grow by 44% to 52%, reaching $4.00 to $4.20[5].

Distribution and Market Expansion

Global Distribution Agreements

The distribution agreement between Antares Pharma and Lunatus Global is a significant step in expanding XYOSTED's market reach. This agreement covers regulatory approvals, promotion, and distribution in the UAE and Saudi Arabia, further solidifying the product's global presence[1][4].

Regulatory Approvals and Launches

Recent regulatory approvals and product launches have been crucial for XYOSTED's market trajectory. The product's approval and relaunch in various regions have helped in increasing its market share and user base[4].

Technological Advancements

ENHANZE Technology

The ENHANZE technology by Halozyme has been a game-changer for subcutaneous delivery systems. This technology enables the rapid administration of large volumes of drugs, making it an essential component of XYOSTED's success. The advancement of this technology continues to support the development of new products and the expansion of existing ones[3][5].

Future Growth Prospects

Pipeline Development

Halozyme's strong pipeline, including products like ocrelizumab SC, nivolumab SC, and amivantamab SC, is expected to contribute significantly to future growth. The company projects an increase in new product launches from 7 in 2023 to 10 by the end of 2025, which will further boost revenue from XYOSTED and other ENHANZE-based products[3].

Market Expansion and Partnerships

Continued market expansion through strategic partnerships and regulatory approvals will be key drivers for XYOSTED's future growth. The increasing demand for convenient and effective treatment options will continue to propel the market for autoinjectors like XYOSTED[1][4].

Key Takeaways

• Strong Revenue Growth: XYOSTED has achieved significant revenue growth, reaching $100 million in sales in 2023.
• Regulatory Approvals: Expansive regulatory approvals and distribution agreements have enhanced the product's market reach.
• Technological Advancements: The ENHANZE technology has been instrumental in the product's success and continues to drive innovation.
• Future Prospects: A robust pipeline and continued market expansion are expected to drive future growth.

Frequently Asked Questions (FAQs)

1. What is XYOSTED, and how does it differ from other testosterone replacement therapies? XYOSTED is a weekly autoinjector for subcutaneous delivery of testosterone replacement therapy, offering a more convenient dosing regimen compared to traditional daily or bi-weekly injections.

2. What are the key drivers of the XYOSTED market? The key drivers include increasing demand for targeted therapies, regulatory approvals, and the impact of the COVID-19 pandemic on home-based treatments.

3. Which companies are involved in the distribution and development of XYOSTED? Antares Pharma, Lunatus Global, and Halozyme are key players involved in the distribution and development of XYOSTED.

4. How has Halozyme's financial performance been impacted by XYOSTED? Halozyme has seen significant revenue growth driven by royalty revenue, collaboration revenue, and product sales from XYOSTED, with a 34% year-over-year increase in total revenue in the third quarter of 2024.

5. What are the future growth prospects for XYOSTED? Future growth is expected to be driven by a robust pipeline of new products, continued market expansion, and strategic partnerships.

Cited Sources

1. Strategic Market Research: Autoinjectors Market Global Industry Growth Trends, 2030.
2. Halozyme: Fourth Quarter and Full Year 2023 Financial and Operating Results.
3. Halozyme: 2023 Annual Report.
4. Cognitive Market Research: Auto injector Market Report.
5. PR Newswire: Halozyme Reports Third Quarter 2024 Financial and Operating Results.