AXIRON Drug Patent Profile

Which patents cover Axiron, and when can generic versions of Axiron launch?

Axiron is a drug marketed by Eli Lilly And Co and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-seven patent family members in fifteen countries.

The generic ingredient in AXIRON 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 Axiron

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

Summary for AXIRON

International Patents:	37
US Patents:	6
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	9
Drug Prices:	Drug price information for AXIRON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AXIRON
What excipients (inactive ingredients) are in AXIRON?	AXIRON excipients list
DailyMed Link:	AXIRON at DailyMed

See drug prices for AXIRON

See drug sales revenues for AXIRON

Recent Clinical Trials for AXIRON

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

Sponsor	Phase
INC Research	Phase 3
Clarus Therapeutics, Inc.	Phase 3
Syneos Health	Phase 3

See all AXIRON clinical trials

Paragraph IV (Patent) Challenges for AXIRON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AXIRON	Topical Solution	testosterone	30 mg/1.5 mL	022504	1	2013-01-29

US Patents and Regulatory Information for AXIRON

AXIRON is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010		DISCN	Yes	No	8,435,944
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010		DISCN	Yes	No	8,993,520
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010		DISCN	Yes	No	9,180,194
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010		DISCN	Yes	No	8,807,861		Y
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010		DISCN	Yes	No	8,419,307
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010		DISCN	Yes	No	9,289,586

Expired US Patents for AXIRON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010	6,299,900
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010	8,071,075
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010	8,784,878
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010	6,923,983
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010	6,818,226

EU/EMA Drug Approvals for AXIRON

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 AXIRON

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

Country	Patent Number	Title	Estimated Expiration
South Africa	200904568	Spreading implement
Germany	122012000021
South Korea	20100055542	TRANSDERMAL DELIVERY RATE CONTROL USING AMORPHOUS PHARMACEUTICAL COMPOSITIONS
Denmark	0901368
Eurasian Patent Organization	200900987	ИНСТРУМЕНТ ДЛЯ НАНЕСЕНИЯ ОБЪЕМА ЖИДКОСТИ НА ОБРАБАТЫВАЕМУЮ ПОВЕРХНОСТЬ, СИСТЕМА И СПОСОБ ТРАНСДЕРМАЛЬНОГО ВВЕДЕНИЯ ФИЗИОЛОГИЧЕСКИ АКТИВНОГО ВЕЩЕСТВА В ОРГАНИЗМ БОЛЬНОГО
Denmark	1674068

Supplementary Protection Certificates for AXIRON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0901368	91973	Luxembourg		91973, EXPIRES: 20220219
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
1769785	91971	Luxembourg		91971, EXPIRES: 20220219
1769785	CA 2012 00012	Denmark
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1769785	CA 2012 00011	Denmark

Market Dynamics and Financial Trajectory for AXIRON

Last updated: July 27, 2025

Introduction

AXIRON (testosterone topical solution, 30 mg per metered dose) represents a significant niche within the male hypogonadism treatment landscape. Approved by the U.S. Food and Drug Administration (FDA) in 2011, AXIRON’s market positioning has been shaped by evolving clinical insights, regulatory decisions, and consumer preferences surrounding testosterone replacement therapy (TRT). Understanding the product’s market dynamics and financial trajectory involves analyzing competitive forces, regulatory impacts, and demographic trends influencing demand.

Market Landscape and Therapeutic Context

The global testosterone replacement therapy market has experienced growth driven by the increasing prevalence of testosterone deficiency, especially among aging males. As per reports, male hypogonadism affects approximately 2-4% of men worldwide, with a rising trend due to increased awareness and diagnosis [1].

AXIRON's mechanism of delivery—topical solution applied to the underarm—offered a non-invasive alternative to intramuscular injections and patches. While topical formulations have been favored for their convenience, their market penetration faced challenges due to safety concerns, such as transference risks, and competition from other formulations like gels, patches, pellets, and injectable testosterone.

Market Dynamics Powering AXIRON

Competitive Landscape

AXIRON entered a competitive arena dominated by established brands like AndroGel (AbbVie), Testim (Bayer), and compounded formulations. Initially positioned as a user-friendly liquid, AXIRON differentiated itself through ease of application and dosage control. However, over time, other products with similar delivery systems and better-established market share have limited AXIRON’s growth potential.

Regulatory Environment

Regulatory scrutiny has critically influenced AXIRON’s market visibility. In 2013, the FDA issued a safety communication emphasizing potential cardiovascular risks associated with testosterone therapy, which prompted clinicians and patients to reevaluate treatment options [2]. Further, in 2015, the FDA recommended that testosterone products carry boxed warnings related to increased risk of cardiovascular events, impacting all testosterone therapy products equally.

Manufacturers faced increasing pressure to implement risk mitigation strategies, affecting market expansion. For AXIRON, FDA warnings translated into cautious prescribing behaviors, restraining substantial sales growth.

Safety and Side Effect Profile

Safety concerns regarding the transference of testosterone from topical applications to others via skin contact put additional constraints on AXIRON's market growth. Although the product was formulated to minimize this risk, public perception and physician prescribing habits shifted accordingly. The risk of potential side effects such as erythrocytosis, sleep apnea exacerbation, and prostate issues further constrained aggressive marketing and adoption.

Consumer Preferences and Compliance

Patient preference for less visible and more discreet testosterone delivery systems influenced market shares. While AXIRON's liquid formulation was convenient, some patients favored gels with quicker absorption or longer-lasting patches. Moreover, self-application convenience was compromised due to potential skin transfer risks, impacting compliance and repeat prescriptions.

Financial Trajectory

Sales Performance

AXIRON’s initial sales post-approval in 2011 showed promise; however, growth plateaued within a few years. According to IQVIA data, AXIRON's U.S. quarterly sales peaked around $20 million in 2013 but declined gradually due to market saturation and competitive pressures [3].

Market Share and Revenue Trends

Market share for AXIRON remained modest relative to leading competitors like AndroGel, which historically commanded a dominant position. The decline in sales was exacerbated by the entry of newer formulations and safety advisories, reducing physician confidence.

Strategic Responses and Portfolio Adjustments

AbbVie, the original manufacturer, and later other industry players have occasionally re-evaluated their testosterone portfolios in response to regulatory and safety challenges. Recognizing limited growth potential for AXIRON, some companies shifted focus toward alternative delivery systems with improved safety profiles, such as patches or buccal formulations.

Impact of Regulatory and Social Factors

The combination of regulatory warnings, safety concerns, and shifting medical guidelines curtailed AXIRON’s financial trajectory. Consequently, sales figures deteriorated, and the product was relegated to a niche position in the growing testosterone therapy landscape.

Market Exit and Product Discontinuation

As of recent industry reports, AXIRON has been discontinued by certain manufacturers due to unsustainable sales, limited market uptake, and strategic portfolio re-prioritization. This trend reflects a broader industry shift toward safer and more effective testosterone formulations.

Conclusion

AXIRON's market dynamics reflect the complex interplay of clinical safety concerns, regulatory scrutiny, competitive pressures, and evolving patient preferences. While initially promising, its financial trajectory was hampered by safety communication impacts, stiff competition in the testosterone replacement market, and safety concerns related to topical formulations. The product’s experience underscores the importance of safety profiles, regulatory compliance, and consumer preferences in defining the success of pharmaceutical therapies.

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Key Takeaways

• Market Entry and Competition: AXIRON entered a highly competitive testosterone therapy market dominated by established brands, facing challenges from alternative formulations offering improved safety and convenience.

• Regulatory Impact: Safety advisories from the FDA and other regulatory bodies significantly constrained product growth, emphasizing the importance of safety profiles in therapy adoption.

• Safety Concerns: Transference risks and cardiovascular safety concerns limited clinical and patient enthusiasm, adversely affecting market penetration.

• Financial Decline: Peak sales in the early 2010s waned due to competitive displacement, safety messaging, and declining physician and patient confidence.

• Strategic Market Shift: Industry trends have moved toward safer, longer-lasting, and discreet formulations, contributing to AXIRON’s phased discontinuation and limited future prospects.

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FAQs

1. What was the primary advantage of AXIRON over other testosterone therapies?
   AXIRON’s liquid topical formulation allowed for convenient, controlled dosing applied under the arm, offering an alternative to injections and patches.

2. Why did AXIRON’s sales decline after initial market success?
   Safety concerns, regulatory warnings about cardiovascular risks and transference potential, along with stiff competition, led to declining sales.

3. Has AXIRON been discontinued or withdrawn from the market?
   Several manufacturers have ceased production or marketing AXIRON due to limited sales and shifting industry focus toward safer alternatives.

4. What factors are influencing the future of testosterone replacement therapies?
   Growing safety concerns, regulatory warnings, and consumer preferences for discreet, longer-lasting formulations are shaping market evolution.

5. How do safety concerns impact the financial potential of testosterone therapies?
   Safety issues lead to regulatory restrictions, reduced physician prescribing, and consumer hesitation, constraining revenue growth.

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Sources

[1] Miller, K. (2020). The global market for testosterone replacement therapy: Trends and forecasts. Pharma Marketwatch.
[2] FDA. (2014). Safety communication: Testosterone products and cardiovascular risks. U.S. Food and Drug Administration.
[3] IQVIA. (2022). US Prescription Drug Market Data.