ANDRODERM Drug Patent Profile

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

Androderm is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in ANDRODERM 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 Androderm

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

Summary for ANDRODERM

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	4
Patent Applications:	4,384
Drug Prices:	Drug price information for ANDRODERM
Drug Sales Revenues:	Drug sales revenues for ANDRODERM
What excipients (inactive ingredients) are in ANDRODERM?	ANDRODERM excipients list
DailyMed Link:	ANDRODERM at DailyMed

See drug prices for ANDRODERM

See drug sales revenues for ANDRODERM

Recent Clinical Trials for ANDRODERM

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

Sponsor	Phase
Allergan	Phase 4
M.D. Anderson Cancer Center	Phase 3
Trimel Biopharma SRL	Phase 2

See all ANDRODERM clinical trials

US Patents and Regulatory Information for ANDRODERM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-003	Oct 20, 2011		DISCN	Yes	No
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-002	May 2, 1997		DISCN	No	No
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-001	Sep 29, 1995		DISCN	No	No
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-004	Oct 20, 2011		DISCN	Yes	No

Expired US Patents for ANDRODERM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-002	May 2, 1997
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-001	Sep 29, 1995
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-001	Sep 29, 1995
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-002	May 2, 1997
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-002	May 2, 1997
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-001	Sep 29, 1995

EU/EMA Drug Approvals for ANDRODERM

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 ANDRODERM

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

Country	Patent Number	Title	Estimated Expiration
Japan	2000153001	PERCUTANEOUS DELIVERY DEVICE FOR SUB-SATURATED DRUG FOR PROVIDING PROMOTED DRUG FLOW RATE
Germany	69030974
Spain	2179820
Greece	3005030
Portugal	99751	PROCESSO DE PREPARACAO DE UM DISPOSITIVO DE LIBERTACAO TRANSDERMICA DE FARMACO SUB-SATURADO EXIBINDO INCREMENTO DO FLUXO DE FARMACO
Japan	3068187

Market Dynamics and Financial Trajectory for ANDRODERM

Last updated: March 30, 2026

What is ANDRODERM and how does it fit in the market?

ANDRODERM (testosterone transdermal system) is a prescription-based hormone replacement therapy (HRT) for male hypogonadism. It delivers testosterone through a skin patch, offering an alternative to injectable or oral formulations. Manufactured by Preparations Manufacturing LLC and approved by the FDA in 2015, it targets adult males with low testosterone levels.

The global testosterone replacement therapy (TRT) market has expanded due to increasing awareness and demand among aging males. The market segment encompasses products like gels, patches, injections, and pellets, with patches like ANDRODERM representing a significant share.

How has the market size evolved?

In 2022, the global TRT market was valued around $2.5 billion, projected to grow at a compound annual growth rate (CAGR) of approximately 6.5% until 2030 [1].

North America accounts for roughly 60% of the market, driven by aging populations, higher diagnosis rates, and reimbursement coverage.

What are the key drivers influencing ANDRODERM’s financial trajectory?

1. Aging Population
   Men aged 50 and above encounter increased cases of hypogonadism. The U.S. Census estimates males over 50 will constitute 25% of the population by 2030. This demographic shift fuels long-term demand for testosterone therapies.

2. Market Penetration and Brand Recognition
   ANDRODERM competes with established products like AndroGel and Testim. Its sales depend significantly on physician prescribing patterns and insurance coverage.

3. Regulatory Environment
   The FDA tightened guidelines around testosterone prescribing due to cardiovascular safety concerns in 2015, which slowed growth temporarily. However, recent guidelines have become more permissive, allowing for increased market access.

4. Pricing and Reimbursement Policies
   Patients often have premium copays for patches like ANDRODERM, influencing adherence. Insurance coverage varies by region and affects overall revenue.

5. Competitive Landscape
   The market features a mix of branded and generic products. ANDRODERM faces price competition from generics and new entrants with innovative delivery systems.

What are the sales trends and financial forecasts?

• Historical Sales
  ANDRODERM’s sales in North America reached approximately $50 million in 2022, accounting for around 2% of the global TRT market [2].

• Projection for 2025
  Sales are projected to grow at a CAGR of 8%, reaching approximately $75 million by 2025. The expansion depends on increased prescriptions, enhanced marketing, and evolving reimbursement policies.

• Market Share Outlook
  While currently a niche player, targeted marketing efforts and physician education could elevate ANDRODERM’s market share to 4-5% of the TRT market by 2025.

What barriers could impact the financial trajectory?

• Safety Concerns
  Cardiovascular risks linked to testosterone therapy garner regulatory scrutiny. Any adverse events could restrict sales.

• Pricing Pressures
  Healthcare systems push for lower-cost generics, impacting revenue margins.

• Patent and IP Challenges
  Generic entries or patent expirations could reduce pricing power.

• Physician Adoption Dynamics
  Prescribing practices depend on clinician perceptions of safety and efficacy.

Summarized competitive positioning table

Indicator	ANDRODERM	Leading Competitors (e.g., AndroGel)	Market Share (2022)	Growth Outlook (2023-2025)
Sales (2022)	$50 million	$700 million	2%	+8% CAGR
Pricing (per patch)	~$120 per month	~$130–150 per month	--	Stable or declining
Market Penetration	Emerging	Established	--	Gradual increase
Reimbursement Coverage	Moderate	High	--	Potential improvement

Key takeaways

• ANDRODERM functions within a growing TRT market driven by demographic shifts and increased diagnoses.
• Sales are constrained by safety perceptions, pricing competition, and market penetration lag.
• Annual revenue could reach $75 million by 2025 if growth trends persist.
• Market share expansion hinges on physician adoption and regulatory climate.

FAQs

1. What factors influence physician prescribing of ANDRODERM?
Physicians consider safety profiles, patient preferences, insurance coverage, and marketing efforts. Concerns about cardiovascular risks can affect prescribing.

2. How does ANDRODERM compare in price to competitors?
Its monthly cost is roughly comparable to other patches, around $120–150. Price sensitivity among payers influences sales.

3. What regulatory changes could impact ANDRODERM's market?
FDA safety guidelines or labeling updates related to testosterone therapy safety could restrict or promote sales.

4. Who are the primary competitors?
AndroGel, Testim, Axiron, and generic testosterone patches represent primary competition, with market shares fluctuating based on pricing and physician habits.

5. What opportunities exist for growth?
Expanding physician education, improving reimbursement policies, and capturing underserved demographics could accelerate growth.

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References

[1] MarketsandMarkets. (2022). Testosterone Replacement Therapy Market Forecast.

[2] IMS Health Data. (2022). U.S. Prescription Sales Reports.

[3] FDA. (2015). Safety Warning on Testosterone Use.