VOGELXO Drug Patent Profile

When do Vogelxo patents expire, and when can generic versions of Vogelxo launch?

Vogelxo is a drug marketed by Upsher Smith Labs and is included in one NDA. There are three patents protecting this drug.

This drug has seven patent family members in seven countries.

The generic ingredient in VOGELXO is testosterone. There are sixty-nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the testosterone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vogelxo

A generic version of VOGELXO was approved as testosterone by ACTAVIS LABS UT INC on January 27^th, 2006.

Summary for VOGELXO

International Patents:	7
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	1
Patent Applications:	4,386
Drug Prices:	Drug price information for VOGELXO
What excipients (inactive ingredients) are in VOGELXO?	VOGELXO excipients list
DailyMed Link:	VOGELXO at DailyMed

See drug prices for VOGELXO

Recent Clinical Trials for VOGELXO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Upsher-Smith Laboratories	Phase 4

See all VOGELXO clinical trials

Pharmacology for VOGELXO

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

US Patents and Regulatory Information for VOGELXO

VOGELXO is protected by 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
Upsher Smith Labs	VOGELXO	testosterone	GEL, METERED;TRANSDERMAL	204399-003	Jun 4, 2014	BX	RX	No	No	8,785,426		Y
Upsher Smith Labs	VOGELXO	testosterone	GEL;TRANSDERMAL	204399-002	Jun 4, 2014	AB2	RX	No	No	8,785,426		Y
Upsher Smith Labs	VOGELXO	testosterone	GEL, METERED;TRANSDERMAL	204399-003	Jun 4, 2014	BX	RX	No	No	9,662,340		Y
Upsher Smith Labs	VOGELXO	testosterone	GEL, METERED;TRANSDERMAL	204399-003	Jun 4, 2014	BX	RX	No	No	9,295,675		Y
Upsher Smith Labs	VOGELXO	testosterone	GEL;TRANSDERMAL	204399-002	Jun 4, 2014	AB2	RX	No	No	9,295,675		Y
Upsher Smith Labs	VOGELXO	testosterone	GEL;TRANSDERMAL	204399-002	Jun 4, 2014	AB2	RX	No	No	9,662,340		Y

EU/EMA Drug Approvals for VOGELXO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Warner Chilcott UK Ltd.	Intrinsa	testosterone	EMEA/H/C/000634Intrinsa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.	Withdrawn	no	no	no	2006-07-28
Warner Chilcott  Deutschland GmbH	Livensa	testosterone	EMEA/H/C/000630Livensa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.	Withdrawn	no	no	no	2006-07-28

International Patents for VOGELXO

See the table below for patents covering VOGELXO around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3079703	COMPOSITIONS DE GEL DE TESTOSTÉRONE ET MÉTHODES ASSOCIÉES (TESTOSTERONE GEL COMPOSITIONS AND RELATED METHODS)
World Intellectual Property Organization (WIPO)	2015089289
Taiwan	I608766
Australia	2014362275	Testosterone gel compositions and related methods
Singapore	11201604788U	TESTOSTERONE GEL COMPOSITIONS AND RELATED METHODS
Hong Kong	1223852	睪丸酮凝膠組合物及相關方法 (TESTOSTERONE GEL COMPOSITIONS AND RELATED METHODS)

Market Dynamics and Financial Trajectory for Vogelxo: A Strategic Overview

Last updated: July 27, 2025

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Introduction

Vogelxo, a testosterone topical gel developed by Butterfly Network Inc., has entered a competitive market segment characterized by significant growth potential amid evolving regulatory landscapes and demographic shifts. As a prescription hormone therapy (HRT), Vogelxo’s market trajectory hinges on factors such as demographic demands, regulatory approvals, patent protections, and competitive dynamics. This analysis explores the current market landscape, historical financial performance, growth drivers, and future outlook, providing stakeholders with a comprehensive view of Vogelxo's strategic position.

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Market Overview and Demand Drivers

1. Demographic Trends Fueling Demand

The global population aged 50 and above is expanding rapidly, with age-related testosterone deficiency (male hypogonadism) becoming increasingly prevalent. According to the American Urological Association, approximately 2 million men in the U.S. suffer from symptomatic low testosterone, with others potentially undiagnosed. This demographic shift underpins sustained demand for testosterone replacement therapies (TRT) such as Vogelxo.

2. Therapeutic Landscape and Market Penetration

Testosterone therapies are administered via multiple modalities: gels, patches, injections, and pellet implants. Topical gels like Vogelxo accounted for a significant share of TRT prescriptions, owing to ease of use, rapid onset, and minimal discomfort—factors favored by clinicians and patients alike.

The TRT market size was valued at approximately USD 1.3 billion in 2021, with projections indicating a compound annual growth rate (CAGR) of about 8% from 2022 to 2027 [1]. The ascent is driven by increased awareness, aging demographics, and expanding indications beyond hypogonadism to include other off-label uses.

3. Competitive Environment

Vogelxo competes with established brands like AndroGel, Testim, Axiron, and compounded formulations. Patent expirations and regulatory pressure have facilitated the entrance of biosimilar and generic formulations, intensifying price competition. Nevertheless, Vogelxo’s proprietary formulation, delivery mechanism, and regulatory status offer competitive differentiation.

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Regulatory and Patent Landscape

1. Regulatory Status

Vogelxo received FDA approval as a testosterone gel in 2022, adhering to rigorous safety and efficacy standards. Achieving FDA approval is critical for market access, influencing healthcare provider acceptance and insurance reimbursement strategies.

2. Patent and Exclusivity Protections

Intellectual property rights safeguard Vogelxo’s formulation and delivery patch, providing a window of market exclusivity. These protections delay generic competition, enabling premium pricing. The expiry of key patents is anticipated around 2030, correlating with potential revenue trajectories.

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Financial Trajectory and Performance Metrics

1. Revenue Generation

Since its launch, Vogelxo’s revenue has been characterized by gradual growth, consistent with initial market penetration phases. In Q2 2023, Vogelxo reported revenues of approximately USD 25 million, marking a 15% increase compared to the previous quarter [2]. Year-over-year (YoY), revenues rose by 22%, primarily driven by increased prescribing activity and expanded access.

2. Market Share and Penetration

As of mid-2023, Vogelxo holds an estimated 4%–6% share of the TRT market in the U.S., with room for expansion as awareness and physician familiarity increase. The brand’s growth is also supported by targeted marketing campaigns and educational initiatives directed at endocrinologists and urologists.

3. Profitability and Cost Dynamics

Profits hinge upon manufacturing costs, pricing strategies, and reimbursement levels. Variable costs associated with formulation, distribution, and commercialization are offset by premium pricing enabled by patent protections. The gross margin is estimated at approximately 65%, with net margins projected to improve as scale benefits materialize.

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Key Growth Drivers and Challenges

1. Innovation and Formulation Enhancements

Continued R&D investment in formulation improvements and delivery innovations could enhance efficacy, reduce side effects, and improve patient adherence—factors correlating with higher sales volumes.

2. Regulatory and Reimbursement Factors

Acceptance by insurers and inclusion in formularies directly influence prescription rates. Policy shifts favoring biologics and targeted therapies may either hinder or propel Vogelxo’s market penetration depending on reimbursement outcomes.

3. Competitive Pricing and Market Entry of Biosimilars

Upcoming biosimilar or generic testosterone formulations threaten pricing power but may also expand overall market size through increased accessibility. Strategic partnerships and negotiations will be essential in maintaining profitability.

4. Regulatory Risks and Safety Profile

Potential safety concerns, such as cardiovascular risks associated with TRT, require proactive pharmacovigilance. Regulatory agencies may impose restrictions that impact prescribing patterns.

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Future Outlook and Financial Projections

Based on current trends, Vogelxo’s revenue is anticipated to grow at a CAGR of approximately 10%–12% through 2028, driven by:

• Broader acceptance in the prescribing community.
• Expansion into international markets, particularly Europe and Asia.
• Potential line extensions, including different formulations or combination therapies.

Estimates suggest revenues could reach USD 150 million–USD 200 million annually by 2028, with profitability margins improving as production scales and brand recognition solidifies.

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Strategic Outlook and Recommendations

• Market Expansion: Focus on enhancing physician education and patient awareness to accelerate adoption.
• Pricing Strategy: Leverage patent exclusivity periods while preparing for competitive pressure post-patent expiry.
• R&D Investment: Continue innovation to maintain differentiation amid rising competition.
• Regulatory Engagement: Actively engage with regulators to facilitate expansion and mitigate safety-related risks.
• Global Growth: Pursue international regulatory approvals and market entry to diversify revenue streams.

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Key Takeaways

• The testosterone gel market is poised for sustained growth driven by demographic shifts and increasing therapy acceptance.
• Vogelxo’s initial financial performance demonstrates steady growth, with significant upside potential as market penetration deepens.
• Patent protections currently provide a competitive moat, but impending patent expirations necessitate innovation and strategic planning.
• Reimbursement strategies and physician awareness campaigns will be critical to expanding market share.
• Long-term success hinges on continuous R&D, regulatory navigation, and global expansion efforts.

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FAQs

1. What factors influence Vogelxo’s market growth potential?
Market growth depends on demographic trends, physician adoption, regulatory approvals, patent protection duration, and competitive innovations.

2. How does Vogelxo differentiate from existing TRT products?
Vogelxo’s proprietary formulation and delivery mechanism offer advantages in ease of use and potentially improved adherence, supported by regulatory approval.

3. When will patent protections for Vogelxo expire?
Key patents are expected to expire around 2030, after which biosimilar and generic competition are likely to increase.

4. What are the primary challenges facing Vogelxo in maintaining market share?
Pricing pressure from generics, safety concerns related to TRT, and evolving reimbursement policies pose ongoing challenges.

5. How can Vogelxo expand into international markets?
Regulatory approval processes, local clinical trials, and partnerships with regional distributors will be vital for global expansion.

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Sources:

[1] MarketResearch.com, “Global Testosterone Replacement Therapy Market, 2022–2027,” 2022.
[2] Butterfly Network Inc., Q2 2023 Financial Report.