ANDROGEL Drug Patent Profile

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

Androgel is a drug marketed by Besins Hlthcare and is included in two NDAs. There are eight patents protecting this drug.

This drug has forty-five patent family members in twenty-nine countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Androgel

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

Summary for ANDROGEL

International Patents:	45
US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	55
Patent Applications:	5,172
Drug Prices:	Drug price information for ANDROGEL
Drug Sales Revenues:	Drug sales revenues for ANDROGEL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ANDROGEL
What excipients (inactive ingredients) are in ANDROGEL?	ANDROGEL excipients list
DailyMed Link:	ANDROGEL at DailyMed

See drug prices for ANDROGEL

See drug sales revenues for ANDROGEL

Recent Clinical Trials for ANDROGEL

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

Sponsor	Phase
VA Office of Research and Development	Phase 2
University Medical Center Groningen	N/A
Harvard University	Phase 4

See all ANDROGEL clinical trials

Pharmacology for ANDROGEL

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

US Patents and Regulatory Information for ANDROGEL

ANDROGEL is protected by eight US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Besins Hlthcare	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	022309-001	Apr 29, 2011	AB	RX	Yes	Yes	8,466,138
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012	AB2	RX	Yes	No	8,741,881
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012	AB2	RX	Yes	No	8,486,925		Y
Besins Hlthcare	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	022309-001	Apr 29, 2011	AB	RX	Yes	Yes	8,466,136		Y
Besins Hlthcare	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	022309-001	Apr 29, 2011	AB	RX	Yes	Yes	8,729,057		Y
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-002	Sep 7, 2012		DISCN	Yes	No	8,741,881

Expired US Patents for ANDROGEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	021015-001	Feb 28, 2000	9,132,089*PED
Besins Hlthcare	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	021015-003	Sep 26, 2003	6,503,894*PED
Besins Hlthcare	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	022309-001	Apr 29, 2011	6,503,894*PED
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	021015-001	Feb 28, 2000	9,125,816*PED
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012	6,503,894*PED
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012	9,132,089*PED

EU/EMA Drug Approvals for ANDROGEL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Warner Chilcott UK Ltd.	Intrinsa	testosterone	EMEA/H/C/000634 Intrinsa 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/000630 Livensa 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 ANDROGEL

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

Country	Patent Number	Title	Estimated Expiration
Portugal	1322336
Israel	190522	תכשיר רפואי המכיל ג'ל טסטוסטרון הידרואלכוהולי ושימוש בטסטוסטרון ליצור התכשיר (Hydroalcoholic testosterone gel pharmaceutical composition and the use of testosterone for the manufacture of a composition)
Brazil	0113649
South Korea	20030043949
Hungary	0302921
Spain	2341090

ANDROGEL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AndroGel

Introduction to AndroGel

AndroGel, a testosterone replacement therapy (TRT) developed by Unimed Pharmaceuticals and later acquired by AbbVie, has been a significant player in the men's health market. Here, we delve into the market dynamics and financial trajectory of AndroGel, exploring its rise, challenges, and current market standing.

Development and Initial Success

AndroGel was guided to market by Robert Dudley, who later became the Chairman, CEO, and President of Clarus Therapeutics. The product was a major advancement in TRT, offering a convenient topical gel formulation that improved patient compliance compared to earlier treatments like injections[3].

Peak Sales and Market Dominance

AndroGel achieved remarkable success, with sales peaking at $1.15 billion in 2012. It became AbbVie's second most lucrative drug, following Humira, which treats rheumatoid arthritis[1].

Regulatory Challenges and Label Changes

However, the landscape shifted in 2014 when the U.S. Food and Drug Administration (FDA) announced investigations into the health risks associated with FDA-approved testosterone products. This followed two studies that raised concerns about the potential increased risk of heart attacks and strokes with testosterone use. As a result, the FDA required label changes to clarify approved uses and warn of these potential risks[1].

Impact on Sales

The regulatory changes and increased scrutiny significantly impacted AndroGel's sales. By 2017, sales had dropped to $577 million, a nearly 15% decline from 2016. AbbVie anticipated further decline, projecting sales to reach $475 million in 2018[1].

Market Competition and Evolution

The testosterone gel market has evolved, with several products now available, including Fortesta, Testim, and Natesto. Despite the competition, AndroGel remains a prominent player. The market is driven by factors such as the high prevalence of male hypogonadism, obesity, and the side effects of treatments like chemotherapy and radiation therapy, which can lead to testosterone deficiency[4].

Global Market Trends

The global testosterone gel market is expected to grow from $1.81 billion in 2022 to $2.96 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 6.3%. North America dominates this market due to high government approval rates and the availability of various testosterone gel products. The Asia Pacific region is also expected to show steady growth due to the prevalence of chronic disorders like AIDS and diabetes, which can lead to hypogonadism[4].

Financial Performance of AbbVie

Despite the challenges faced by AndroGel, AbbVie has maintained strong financial performance. In 2018, AbbVie reported full-year net revenues of $32.753 billion, with adjusted net revenues growing 15.2% on an operational basis. The company's adjusted diluted EPS grew by 41.3% to $7.91. Humira, AbbVie's top-selling drug, contributed significantly to these figures, with global sales of $19.936 billion[2].

Future Outlook and Guidance

In subsequent years, AbbVie continued to show robust financial health. For 2019, the company reported full-year net revenues of $33.266 billion, with adjusted net revenues growing 2.7% operationally. The adjusted diluted EPS increased by 13.0% to $8.94. AbbVie provided guidance for 2020, expecting standalone revenue growth of around 8.0% on an operational basis[5].

Lessons Learned and Market Adaptation

The journey of AndroGel highlights the importance of regulatory compliance and market adaptation. Robert Dudley's experience with AndroGel and later with Jatenzo, an oral testosterone formulation, underscores the need for thorough data and rigorous regulatory review. The success of AndroGel also emphasized the prevalence and impact of testosterone deficiency, driving further innovation in TRT[3].

Key Takeaways

• Regulatory Impact: Changes in FDA regulations significantly affected AndroGel's sales and market trajectory.
• Market Growth: The global testosterone gel market is expected to grow, driven by increasing prevalence of male hypogonadism and other health conditions.
• Financial Performance: Despite challenges, AbbVie has maintained strong financial performance, largely due to its diversified portfolio and the success of other drugs like Humira.
• Innovation and Compliance: The development and approval process for TRT products have become more rigorous, emphasizing the need for comprehensive data and regulatory compliance.

FAQs

What was the peak sales year for AndroGel?

AndroGel's sales peaked in 2012, reaching $1.15 billion.

How did FDA label changes affect AndroGel sales?

The FDA's requirement for label changes to warn of potential cardiovascular risks led to a significant decline in AndroGel sales, from $577 million in 2017 to a projected $475 million in 2018.

What drives the growth of the testosterone gel market?

The market is driven by factors such as the high prevalence of male hypogonadism, obesity, and the side effects of treatments like chemotherapy and radiation therapy.

How has AbbVie's financial performance been despite AndroGel's decline?

AbbVie has maintained strong financial performance, driven by the success of other drugs like Humira and overall operational revenue growth.

What are the future prospects for the testosterone gel market?

The global testosterone gel market is expected to grow to $2.96 billion by 2030, with a CAGR of 6.3% from 2023 to 2030.

Sources

1. Chicago Tribune: "AbbVie, facing thousands of lawsuits about its AndroGel testosterone supplement, notches a significant win"
2. AbbVie Investors: "AbbVie Reports Full-Year and Fourth-Quarter 2018 Financial Results"
3. The Medicine Maker: "Devoted to Men's Health: Lessons Learned with Robert Dudley"
4. Next MSC: "Testosterone Gel Market Size and Share | Statistics – 2030"
5. AbbVie Investors: "AbbVie Reports Full-Year and Fourth-Quarter 2019 Financial Results"