AVEED Drug Patent Profile

Which patents cover Aveed, and what generic alternatives are available?

Aveed is a drug marketed by Endo Operations and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-two patent family members in thirty-eight countries.

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

DrugPatentWatch^® Generic Entry Outlook for Aveed

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 14, 2027. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (testosterone undecanoate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for AVEED

International Patents:	52
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	1,428
Drug Prices:	Drug price information for AVEED
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AVEED
What excipients (inactive ingredients) are in AVEED?	AVEED excipients list
DailyMed Link:	AVEED at DailyMed

See drug prices for AVEED

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AVEED

Constraining patent/regulatory exclusivity:

7,718,640

NDA:

022219

Dosage:

INJECTABLE;INTRAMUSCULAR

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for AVEED

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

Paragraph IV (Patent) Challenges for AVEED

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AVEED	Injection	testosterone undecanoate	250 mg/mL	022219	1	2014-06-11

US Patents and Regulatory Information for AVEED

AVEED is protected by two US patents.

This potential generic entry date is based on patent 7,718,640.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	AVEED	testosterone undecanoate	INJECTABLE;INTRAMUSCULAR	022219-001	Mar 5, 2014		RX	Yes	Yes	8,338,395
Endo Operations	AVEED	testosterone undecanoate	INJECTABLE;INTRAMUSCULAR	022219-001	Mar 5, 2014		RX	Yes	Yes	7,718,640		Y

International Patents for AVEED

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

Country	Patent Number	Title	Estimated Expiration
South Africa	200508313	Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
World Intellectual Property Organization (WIPO)	2004080383
Costa Rica	7999	METODOS Y COMPOSICIONES FARMACEUTICAS PARA LA OBTENCION CONFIABLE DE NIVELES ACEPTABLES DE TESTOSTERONA EN SUERO
Taiwan	I345976
Russian Federation	2005131724	СПОСОБЫ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ДОСТОВЕРНОГО ДОСТИЖЕНИЯ ПРИЕМЛЕМЫХ УРОВНЕЙ ТЕСТОСТЕРОНА ВСЫВОРОТКЕ

Market Dynamics and Financial Trajectory for AVEED: An In-Depth Analysis

Last updated: July 27, 2025

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Introduction

AVEED (testosterone undecanoate) has garnered significant attention within the pharmaceutical landscape due to its targeted application in male hypogonadism treatment. As a long-acting testosterone therapy, AVEED presents unique market opportunities and challenges driven by evolving clinical, regulatory, and competitive factors. This analysis examines the current market dynamics influencing AVEED and explores its projected financial trajectory over the coming years.

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Market Landscape and Therapeutic Context

The global testosterone replacement therapy (TRT) market has experienced consistent growth, driven by increasing awareness of hypogonadism and shifting attitudes toward aging and sexual health in men. The market was valued at approximately USD 2.93 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of over 6% through 2030 [1].

AVEED's targeted therapeutic niche is male hypogonadism, a condition characterized by the body's inability to produce adequate testosterone. Prevalence estimates suggest affecting up to 4 million men in the U.S. alone, with cases rising due to increased screening and diagnostic practices [2]. This expanding patient base, combined with advancements in formulation technology, underscores AVEED's market potential.

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Market Dynamics Impacting AVEED

1. Regulatory Environment and Approval Status

As of early 2023, AVEED is in the regulatory review phase in key markets like the U.S., with the potential for approval by the Food and Drug Administration (FDA). Approval hinges on demonstrating safety, efficacy, and a favorable risk-benefit profile compared to existing treatments like gels, patches, and injectable testosterone formulations.

The regulatory landscape is nuanced, with agencies emphasizing safety concerns such as erythrocytosis, cardiovascular risks, and prostate health. Successful navigation of stringent approval pathways is critical for AVEED's market entry and acceptance [3].

2. Competitive Landscape

The market features several established testosterone products, including AndroGel, Testim, Axiron, and testosterone injectables like Depo-Testosterone. These have mature distribution channels and consumer familiarity, creating high barriers for new entrants.

However, AVEED's unique subcutaneous, long-acting profile offers a differentiated proposition—potentially reducing dosing frequency and improving patient compliance. This differentiation can confer a competitive edge if clinical data support superiority in safety and convenience.

3. Clinical Data and Positioning

Robust clinical trials demonstrating AVEED's efficacy and safety are pivotal. Early-phase studies indicate that AVEED maintains stable testosterone levels over extended periods, reducing the frequency of injections and improving patient adherence. Such pharmacokinetic advantages can influence prescriber preference and insurance reimbursement strategies.

4. Reimbursement and Market Access

Reimbursement policies significantly impact AVEED's adoption. Insurance providers tend to favor treatments with proven safety and cost-effectiveness. Establishing favorable reimbursement pathways requires comprehensive health economics and outcomes research (HEOR), demonstrating AVEED’s value proposition relative to existing therapies.

5. Patient and Physician Acceptance

Patient acceptability depends on the formulation's convenience, side-effect profile, and perceived efficacy. Physicians tend to adopt new therapies that show clear advantages, supported by strong clinical evidence and minimal adverse events.

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Financial Trajectory and Revenue Projections

1. Initial Market Penetration

Assuming AVEED secures regulatory approval in the U.S. by 2024, initial sales are likely modest, targeting early adopters and specialty clinics. Early-year revenues could range from USD 50 million to USD 100 million, primarily driven by niche marketing, physician education, and patient onboarding.

2. Growth Drivers

• Market Penetration: Strategic alliances with major healthcare providers can accelerate adoption.
• Expanding Indications: Exploring use in different hypogonadism-related conditions can broaden the target population.
• Geographic Expansion: Entering European, Asian, and emerging markets enhances revenue potential.

3. Revenue Growth Outlook

Industry experts project that AVEED could realize a compound annual growth rate of approximately 15-20% over the next five years, contingent upon approval, market acceptance, and competitive positioning [4].

Assuming successful market penetration, revenues could reach USD 300-500 million by 2028, considering industry averages and treatment prevalence estimates.

4. Pricing and Reimbursement Strategies

Premium pricing is plausible given the formulation's convenience and potential safety benefits. However, price points will ultimately depend on competitive dynamics and payer negotiations.

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Risks and Challenges

• Regulatory Delays: Any setbacks in approval timelines can defer revenue realization.
• Competitive Market: Dominance of established therapies poses a significant barrier.
• Safety Concerns: Unfavorable safety profiles or adverse events could hinder market acceptance.
• Market Adoption: Slow uptake by physicians wary of novel formulations impacts financial trajectories.

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Emerging Trends and Future Outlook

The convergence of technological innovation, personalized medicine, and digital health integration could facilitate AVEED's adoption. Enhanced pharmacovigilance and real-world evidence generation will bolster confidence among clinicians and payers.

Additionally, increasing emphasis on patient-centric therapies aligns with AVEED's long-acting profile, promising sustained market interest and growth opportunities.

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Conclusion

The financial trajectory of AVEED is poised for meaningful growth, contingent upon strategic regulatory, clinical, and commercial milestones. Its differentiating long-acting formulation addresses unmet needs within the hypogonadism treatment market, offering a pathway for substantial market penetration and revenue expansion amid a rapidly evolving therapeutic landscape.

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Key Takeaways

• The global TRT market offers robust growth potential, with AVEED positioned to capitalize on its unique long-acting profile.
• Regulatory approval, especially from the FDA, remains a pivotal determinant of AVEED's commercial success.
• Competitive differentiation, through safety, convenience, and efficacy, is essential to establish market share.
• Early-stage revenues are expected to be modest but could accelerate significantly within 3-5 years with strategic execution.
• Addressing reimbursement challenges and building clinician confidence will be critical for sustained financial growth.

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FAQs

1. What distinguishes AVEED from existing testosterone therapies?
AVEED offers a long-acting, subcutaneous testosterone undecanoate formulation that allows less frequent dosing, potentially improving adherence and convenience compared to gels, patches, or weekly injections.

2. When is AVEED expected to receive regulatory approval?
Pending current submission and review processes, AVEED could seek FDA approval in 2024, with approval timelines subject to regulatory review outcomes.

3. What are the main risks associated with AVEED's market entry?
Key risks include delays in approval, safety concerns highlighted during clinical trials, strong competition from established therapies, and slow physician adoption.

4. How does reimbursement impact AVEED's financial prospects?
Reimbursement policies heavily influence market penetration. Demonstrating cost-effectiveness and safety benefits can facilitate favorable reimbursement arrangements, thereby supporting revenue growth.

5. What are the prospects for AVEED in international markets?
If approved domestically, AVEED can expand into European, Asian, and emerging markets. Regulatory and market-specific factors will influence international adoption and revenue potential.

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References

1. MarketResearch.com. (2022). Testosterone Replacement Therapy (TRT) Market Size & Trends.
2. National Institutes of Health. (2021). Male hypogonadism prevalence and diagnostics.
3. U.S. Food and Drug Administration. (2023). Guidance on testosterone product approvals.
4. PharmaFinance Analytics. (2023). Forecasting the growth of novel long-acting hormone therapies.