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 fifty patent family members in thirty countries.

The generic ingredient in ANDROGEL 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 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:	50
US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	55
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
National Heart, Lung, and Blood Institute (NHLBI)	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
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012	AB2	RX	Yes	No
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012	AB2	RX	Yes	No			Y
Besins Hlthcare	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	022309-001	Apr 29, 2011	AB	RX	Yes	Yes			Y
Besins Hlthcare	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	022309-001	Apr 29, 2011	AB	RX	Yes	Yes			Y
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-002	Sep 7, 2012	AB2	RX	Yes	No
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012	AB2	RX	Yes	No

Expired US Patents for ANDROGEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012
Besins Hlthcare	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	022309-001	Apr 29, 2011
Besins Hlthcare	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	021015-003	Sep 26, 2003
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-002	Sep 7, 2012
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-002	Sep 7, 2012
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-002	Sep 7, 2012

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/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 ANDROGEL

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4397367
Eurasian Patent Organization	007431	АНДРОГЕННАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ И СПОСОБ ДЛЯ ЛЕЧЕНИЯ ДЕПРЕССИИ (ANDROGEN PHARMACEUTICAL COMPOSITION AND METHODS FOR TREATING DEPRESSION)
Canada	2624788
Norway	20030954
Morocco	29941	GEL DE TESTOSTERONE AMELIORE ET PROCEDE D'UTILISATION
Mexico	PA03001858	METODO PARA EL TRATAMIENTO DE LA DISFUNCION ERECTIL E INCREMENTO EN EL LIBIDO DEL HOMBRE. (METHOD FOR TREATING ERECTILE DYSFUNCTION AND INCREASING LIBIDO IN MEN.)
Eurasian Patent Organization	200401210

ANDROGEL: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is ANDROGEL and its Therapeutic Role?

ANDROGEL (testosterone gel) is a topical medication prescribed for men diagnosed with hypogonadism, a condition characterized by insufficient testosterone production. It delivers testosterone through the skin, aiming to restore physiological testosterone levels and alleviate symptoms such as fatigue, decreased libido, and loss of muscle mass. ANDROGEL is formulated as a clear, colorless hydroalcoholic gel and is typically applied once daily to the shoulders and upper arms.

Who Markets ANDROGEL and What is its Regulatory Status?

AbbVie Inc. (NYSE: ABBV) markets ANDROGEL in the United States. It is also marketed by Abbott Laboratories in various international markets. ANDROGEL is approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypogonadism. The initial FDA approval for ANDROGEL was granted in 2000. As of the latest available data, ANDROGEL holds a significant position in the testosterone replacement therapy (TRT) market. Its regulatory status is maintained through ongoing post-market surveillance and adherence to FDA guidelines.

What is the Global Market Size and Growth Projection for ANDROGEL?

The global market for testosterone replacement therapy, within which ANDROGEL operates, is substantial. While specific market size figures for ANDROGEL alone are proprietary, the broader TRT market was valued at approximately \$2.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4% to 6% through 2030. This growth is driven by an aging male population, increasing awareness of hypogonadism, and a growing acceptance of TRT. Key market segments include injectable, transdermal, and oral testosterone therapies. ANDROGEL, as a leading transdermal option, is expected to maintain a stable market share within this expanding landscape.

What are the Key Drivers of ANDROGEL's Market Performance?

Several factors influence ANDROGEL's market performance:

• Prevalence of Hypogonadism: The increasing diagnosis of hypogonadism, particularly in men over 40, is a primary driver. Factors contributing to this include rising rates of obesity, diabetes, and metabolic syndrome, all of which are associated with lower testosterone levels.
• Patient and Physician Preference for Topical Delivery: ANDROGEL's gel formulation offers a convenient, once-daily application method that mimics natural testosterone release patterns. This can be preferred by some patients and physicians over injections, which may involve more frequent administrations and potential pain at the injection site.
• Brand Recognition and Established Market Presence: ANDROGEL has been available for over two decades, establishing significant brand recognition and a loyal patient base. AbbVie's marketing efforts and established distribution channels contribute to its sustained market presence.
• Technological Advancements in TRT: While ANDROGEL is a mature product, ongoing research and development in TRT delivery systems, including newer topical formulations and long-acting injectables, represent a competitive factor. However, existing products like ANDROGEL benefit from their established efficacy and safety profiles.
• Regulatory Landscape: FDA approvals and ongoing safety monitoring by regulatory bodies are critical. Any changes in regulatory guidance regarding testosterone therapy, particularly concerning cardiovascular risks or potential for abuse, can impact market dynamics.

What is ANDROGEL's Competitive Landscape?

The TRT market is competitive, with several therapeutic classes and individual products vying for market share.

Key Competitors and Product Categories:

• Other Transdermal Gels: ANDROGEL competes with other testosterone gels, such as Testim (Auxilium Pharmaceuticals/Endo International) and Fortesta (Endo International). These products offer similar delivery mechanisms and therapeutic benefits, often differentiated by minor formulation differences or pricing strategies.
• Injectable Testosterone: This remains a significant segment of the TRT market. Examples include:
  • Testosterone Enanthate and Cypionate: Long-established injectable formulations.
  • Nebido (Testosterone Undecanoate): A long-acting injectable providing infrequent dosing.
• Testosterone Pellets: Subcutaneous implants that release testosterone over several months, such as Testopel.
• Oral Testosterone: While less common due to concerns about liver toxicity, some oral formulations exist.

Market Share Dynamics:

ANDROGEL historically held a leading position among topical testosterone products. However, the competitive landscape is dynamic, with market share influenced by factors such as:

• New Product Launches: The introduction of novel TRT formulations or delivery systems can shift market preferences.
• Generic Competition: While ANDROGEL has patent protection, the potential for generic alternatives or biosimil-like products in the future (though less common for small molecules/formulations) is a long-term consideration.
• Pricing and Reimbursement: Payer policies and drug pricing significantly impact product adoption.
• Physician Prescribing Habits: Physician familiarity and comfort with specific TRT agents play a crucial role.

What is the Patent and Exclusivity Status of ANDROGEL?

ANDROGEL benefits from patent protection and market exclusivity granted by regulatory authorities. The original patents protecting ANDROGEL's composition of matter and method of use have largely expired. However, secondary patents related to specific formulations, manufacturing processes, or new indications may still be in effect or have recently expired.

• Key Patent Expirations: Original composition of matter patents for testosterone gels have expired, allowing for the potential development of generic versions.
• Exclusivity Periods: ANDROGEL has benefited from periods of U.S. market exclusivity granted by the FDA. For instance, the 5-year New Chemical Entity (NCE) exclusivity would have applied to its initial approval.
• Ongoing Litigation: As patents expire, there is potential for patent litigation if generic manufacturers attempt to enter the market. AbbVie has a history of defending its patents for key products.
• Impact of Exclusivity Loss: The expiration of key patents and exclusivity periods generally leads to the introduction of generic or biosimilar competitors, resulting in significant price erosion and a decrease in the branded product's market share.

As of recent filings, ANDROGEL continues to face competition from generic testosterone products and other TRT options. The precise status of all active patents and their expiration dates is complex and subject to ongoing legal challenges and regulatory filings.

What is ANDROGEL's Financial Performance and Sales Trajectory?

AbbVie's financial reporting provides insights into ANDROGEL's performance within its broader portfolio. As a mature product, ANDROGEL's sales trajectory is influenced by market maturity, competition, and pricing pressures.

• Historical Sales Trends: ANDROGEL was a significant revenue generator for AbbVie and its predecessor, Abbott Laboratories, in the early to mid-2000s. Peak sales were achieved during its period of strong market exclusivity.
• Recent Sales Performance: In recent years, ANDROGEL's sales have experienced a decline due to increased generic competition and the availability of alternative TRT options. For example, AbbVie's reported net revenues for ANDROGEL in the U.S. have shown a downward trend. In 2022, U.S. net revenue for ANDROGEL was approximately \$200 million, a decrease from previous years. (Source: AbbVie Annual Reports, 2021-2022).
• Global Sales: While U.S. sales are a significant indicator, global sales figures, which include markets managed by Abbott, also contribute to the overall financial picture. However, aggregated global sales data for ANDROGEL specifically is often not broken out separately in public filings.
• Projected Trajectory: The financial trajectory for ANDROGEL is expected to continue to be influenced by generic penetration. While it remains a prescribed treatment, its revenue contribution is likely to diminish gradually. AbbVie's strategic focus has shifted towards newer, higher-growth products in its pipeline, such as immunology and oncology drugs.

What are the Key Risks and Challenges Facing ANDROGEL?

• Generic Competition: The most significant risk is the ongoing and increasing competition from generic testosterone products. Once patents expire, the market becomes susceptible to price erosion as multiple manufacturers offer lower-cost alternatives.
• Regulatory Scrutiny and Safety Concerns: Testosterone therapies, including ANDROGEL, have faced scrutiny regarding potential cardiovascular risks, stroke, and other adverse events. Regulatory bodies and medical associations continue to monitor safety data, which could lead to revised prescribing guidelines or warnings, impacting physician prescribing and patient demand. A 2015 FDA safety review recommended including a warning about increased risk of heart attack and stroke in testosterone product labeling.
• Shifting Treatment Paradigms: Advances in TRT, such as new long-acting injectables or improved topical formulations, may offer superior efficacy, convenience, or safety profiles, leading patients and physicians to switch from ANDROGEL.
• Pricing Pressures and Reimbursement Policies: Payers, including insurance companies and government health programs, are increasingly scrutinizing the cost-effectiveness of TRT. Changes in reimbursement policies or preferred drug lists can significantly impact ANDROGEL's market access and affordability for patients.
• Patient Adherence and Side Effects: While generally well-tolerated, some patients may experience skin irritation or other side effects from topical application. Non-adherence to the daily regimen can also limit therapeutic effectiveness.

Key Takeaways

• ANDROGEL is a leading topical testosterone replacement therapy with significant historical market presence.
• The broader TRT market is growing, driven by increasing diagnoses of hypogonadism.
• ANDROGEL faces substantial competition from other topical gels, injectables, and pellets, as well as generic versions.
• Original patents for ANDROGEL have expired, leading to price erosion and declining U.S. sales, which were approximately \$200 million in 2022.
• Key risks include ongoing generic competition, regulatory scrutiny regarding safety, and the development of newer TRT alternatives.

FAQs

1. What is the primary therapeutic indication for ANDROGEL?

ANDROGEL is indicated for men diagnosed with hypogonadism, a condition characterized by insufficient testosterone production.

2. Which company currently markets ANDROGEL in the United States?

AbbVie Inc. (NYSE: ABBV) markets ANDROGEL in the United States.

3. What are the main competing product categories for ANDROGEL in the testosterone replacement therapy market?

Competing product categories include other transdermal gels, injectable testosterone formulations, and testosterone pellets.

4. What has been the trend in ANDROGEL's U.S. sales in recent years?

ANDROGEL's U.S. sales have experienced a decline in recent years due to generic competition and market dynamics.

5. What is a significant safety concern associated with testosterone therapies, including ANDROGEL?

A significant safety concern is the potential increased risk of cardiovascular events, such as heart attack and stroke, which has led to updated warnings on product labeling.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Prescription Drug Information. Retrieved from [FDA Website] [2] AbbVie Inc. (2022). Annual Report on Form 10-K for the fiscal year ended December 31, 2022. [3] Global Market Insights. (2023). Testosterone Replacement Therapy Market Analysis Report. [4] Market Research Future. (2023). Testosterone Replacement Therapy Market Research Report. [5] FDA. (2015, June 18). FDA Drug Safety Communication: FDA strengthens warning for testosterone products about potential for abuse or misuse. Retrieved from [FDA Website]