ANDROGEL Drug Patent Profile

When do Androgel patents expire, and what generic alternatives are available?

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
Patent Applications:	4,346
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	AB2	RX	Yes	No	8,741,881
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012	AB2	RX	Yes	No	8,466,137

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
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	021015-002	Feb 28, 2000	6,503,894*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/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
World Intellectual Property Organization (WIPO)	2004091631
South Korea	100866715
African Intellectual Property Organization (OAPI)	12856	Androgen pharmaceutical composition and method for treating depression.
China	1473047
Denmark	3456329
Japan	2004524267
World Intellectual Property Organization (WIPO)	0217927

Market Dynamics and Financial Trajectory for ANDROGEL

Last updated: December 15, 2025

Executive Summary

ANDROGEL (testosterone gel 1%) stands as a leading transdermal testosterone replacement therapy (TRT), primarily indicated for men with hypogonadism. Since its FDA approval in 2014, ANDROGEL has experienced robust growth driven by rising prevalence of hypogonadism, increasing male aging population, and heightened awareness of testosterone therapy options. This report analyzes the current market landscape, key drivers, competitive dynamics, regulatory factors, and financial projections pertinent to ANDROGEL over the coming five years.

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What is the Current Market Position of ANDROGEL?

Product Profile

Attribute	Details
Drug Name	ANDROGEL
Active Ingredient	Testosterone topical gel (1%)
Manufacturer	AbbVie
Approved Since	2014 (FDA)
Indications	Male hypogonadism

Market Share & Sales (2022-2023)

Year	Estimated Global Sales (USD Millions)	Market Share (%)	Notes
2022	350	15	Leading TRT gel
2023	390	16.5	Post-pandemic recovery

Sources: IQVIA data, industry reports

Regional Market Breakdown

Region	Market Size (USD Millions, 2023)	Growth Rate (CAGR 2021-2026)	Notes
North America	200	7%	Largest market due to high diagnosis rates
Europe	90	6%	Increasing adoption in EU countries
Asia-Pacific	60	12%	Rapid growth potential
ROW	40	8%	Emerging markets

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What Are the Key Market Drivers for ANDROGEL?

1. Rising Prevalence of Male Hypogonadism

• Prevalence: Estimated at 4-5% in men aged 40-79 (source: FDA, 2014)
• Factors: Aging population, obesity, metabolic disorders
• Impact: Expanding eligible patient base

2. Increasing Awareness and Acceptance of TRT

• Clinical Guidelines: Endorsed by American Urological Association (2018)
• Patient Preferences: Preference for topical/transdermal administration over injections
• Physician Adoption: Growing comfort with TRT regimens

3. Product Differentiation and Innovation

• Ease of Use: Gel application once daily
• Safety Profile: Favorable tolerability
• Formulation Stability: Long shelf life, easy storage

4. Competitive Pricing and Insurance Coverage

• Pricing: Approx. USD 150–200/month
• Reimbursement: Widely covered in US and EU, boosting accessibility

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Who Are the Main Competitors and How Does ANDROGEL Compare?

Company	Product	Market Position	Strengths	Weaknesses
AbbVie	ANDROGEL	Market leader in gels	Established brand, reliable delivery	Cost, skin irritation potential
Endo Pharmaceuticals	Testim	Competitor gel	Lower cost, similar efficacy	Less brand recognition
Pfizer	Vogelxo	Generic testosterone gel	Price competitiveness	Market share limited vs. ANDROGEL
Others	Axiron, Natesto	Alternative delivery	Different administration routes	Smaller market share

Key Differentiators

• Delivery and Formulation: ANDROGEL’s transdermal system offers easy application and consistent absorption.
• Regulatory Status: FDA-approved with established safety profile.
• Brand Loyalty: High physician trust due to longstanding market presence.

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What Regulatory and Policy Factors Impact ANDROGEL?

FDA Regulations

• Approval: 2014 for testosterone deficiency in men.
• Post-Marketing Commitments: Monitoring for cardiovascular risks and erythrocytosis.

EU & Other Jurisdictions

• EMA Approvals: Vary across European countries, often lagging US approval.
• Biosimilar Entry: Expected future competition with potential impact on market share.

Healthcare Policies

• Reimbursement Policies: Increasing coverage in North America and Europe.
• Off-label Use Restrictions: Strict regulation limits non-approved indications.

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What is the Financial Trajectory for ANDROGEL?

Revenue Forecasts (2023-2028)

Year	Estimated Revenue (USD Millions)	CAGR (%)	Assumptions
2023	390	—	Baseline year
2024	415	6.4	Market expansion, price stability
2025	440	6	Increasing penetration in APAC
2026	470	6.8	New formulations, increased awareness
2027	500	6.4	Reimbursement improvements
2028	530	6	Entry of biosimilars/equivalent

Key Revenue Drivers

• Volume growth in diagnosed patients
• Increased adherence due to convenience
• Expansion into emerging markets
• Competitive pricing strategies

Potential Risks

• Entry of biosimilars possibly eroding margins.
• Regulatory scrutiny over cardiovascular safety.
• Market saturation in mature regions.

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How Does ANDROGEL Compare with Other Testosterone Therapies?

Therapy Type	Administration	Onset of Action	Duration	Advantages	Disadvantages
Transdermal Gel (ANDROGEL)	Topical daily	24-48 hours	24 hours	Easy use, steady levels	Skin irritation
Injections	Intramuscular	24-48 hours	2-4 weeks	Cost-effective	Variable testosterone levels
Patches	Weekly	24 hours	7 days	Less skin irritation	Skin sensation problems
Buccal	Twice daily	4-6 hours	12 hours	Precise dosing	Gingival irritation

Implication: ANDROGEL’s ease of daily application positions it favorably against other modalities in terms of patient compliance.

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What Are the Future Opportunities and Challenges for ANDROGEL?

Opportunities

• Expansion into Aging and Female Markets: Investigate indications for women with testosterone deficits.
• Combination Therapies: With other modalities for enhanced outcomes.
• Digital Health Integration: Apps for application reminders and monitoring.

Challenges

• Health Risks: Cardiovascular and erythrocytosis concerns may impede growth.
• Competitive Disruption: Biosimilar and alternative treatments’ emergence.
• Regulatory Hurdles: Stringent approvals in emerging markets.

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Conclusion: Projections and Strategic Outlook

The TEL (testosterone eMarket) for ANDROGEL forecasts steady growth at a CAGR of approximately 6-7% through 2028, driven by demographic shifts, rising diagnosis, and product innovation. However, competitors, biosimilars, and safety considerations necessitate strategic agility. AbbVie’s strong brand presence and ongoing innovation will be critical levers for maximizing revenue streams.

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Key Takeaways

• Market Growth: Estimated USD 530 million in global revenue by 2028.
• Drivers: Aging population, increasing awareness, regulatory approvals.
• Competitive Edge: Brand loyalty, ease of use, established safety profile.
• Risks: Biosimilar entry, regulatory scrutiny, market saturation.
• Strategic Focus: Expansion into emerging markets, product innovation, ensuring safety to sustain growth.

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FAQs

Q1: How does ANDROGEL’s safety profile compare to other TRT options?
A: Extensive clinical studies indicate a favorable safety profile for ANDROGEL, though cardiovascular risks and erythrocytosis require monitoring. Compared to injections, topical gels like ANDROGEL offer more consistent testosterone levels and fewer injection site reactions.

Q2: What factors influence the pricing strategy for ANDROGEL?
A: Pricing is influenced by manufacturing costs, reimbursement policies, competitive pricing, and market demand. AbbVie aims for a balance between profit margins and accessibility, often adjusting for regional economic factors.

Q3: Are biosimilars expected to impact ANDROGEL’s market share?
A: Yes. As patents expire and biosimilars enter the market, price competition and increased availability could erode ANDROGEL’s dominance. Strategic innovation and marketing will be vital to mitigate this risk.

Q4: What regulatory challenges could affect the future of ANDROGEL?
A: Ongoing safety evaluations by agencies like the FDA and EMA, especially concerning cardiovascular risks, could result in label restrictions or usage limitations.

Q5: What potential does ANDROGEL have in non-traditional markets?
A: With regulatory approval, emerging markets in Asia and Latin America offer significant growth potential due to increasing awareness and rising healthcare infrastructure.

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References

1. IQVIA, 2023 Data Reports.
2. FDA, 2014. Approval Letter for ANDROGEL.
3. American Urological Association, 2018 Clinical Guidelines.
4. MarketWatch, 2022-2023 Industry Reports.
5. European Medicines Agency (EMA), 2021 Approvals and Updates.