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

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.

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
Endo Operations	AVEED	testosterone undecanoate	INJECTABLE;INTRAMUSCULAR	022219-001	Mar 5, 2014		RX	Yes	Yes			Y

International Patents for AVEED

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1457208	Procédés et compositions pour atteindre avec fiabilité à un niveau de testostérone acceptable dans le sérum (Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels)
New Zealand	542321	Methods and pharmaceutical compositions comprising testosterone esters
Ecuador	SP056095	MÉTODOS Y COMPOSICIONES FARMACÉUTICAS PARA LA OBTENCIÓN CONFIABLE DE NIVELES ACEPTABLES DE TESTOSTERONA EN SUERO
Montenegro	P14508	POSTUPCI I FARMACEUTSKI SASTAVI ZA POUZDANO POSTIZANJE PRIHVATLJIVIH NIVOA SERUMA TESTOSTERONA (METHODS AND PHARMACEUTICAL COMPOSITIONS FOR RELIABLE ACHIEVEMENT OF ACCEPTABLE SERUM TESTOSTERONE LEVELS)
Eurasian Patent Organization	200501819	СПОСОБЫ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ДОСТОВЕРНОГО ДОСТИЖЕНИЯ ПРИЕМЛЕМЫХ УРОВНЕЙ ТЕСТОСТЕРОНА В СЫВОРОТКЕ

Market Dynamics and Financial Trajectory for AVEED (Testosterone Undecanoate)

Last updated: December 27, 2025

Summary

AVEED (Testosterone Undecanoate) is a long-acting testosterone replacement therapy (TRT) designed for adult males with hypogonadism. Approved by the FDA in 2014, AVEED's market trajectory is shaped by evolving regulatory landscapes, competitive dynamics, clinical efficacy, safety profiles, and healthcare policy shifts. Despite its promising pharmacokinetics, AVEED faces challenges from newer formulations such as gels, patches, and injections that impact market share. This analysis explores the current and projected market environment, financial performance, regulatory considerations, and strategic factors influencing AVEED’s commercial potential.

---

What Is AVEED and How Does It Fit Into the Testosterone Therapy Market?

Product Overview:

Attribute	Details
Generic Name	Testosterone Undecanoate
Brand Name	AVEED
Approval Date	March 2014 (FDA)
Indication	Testosterone replacement in adult males with hypogonadism
Dosage	1000 mg (intramuscular injection, every 10 weeks)

Key Features:

• Long-acting injectable formulation
• Administered via intramuscular injection every 10 weeks
• Designed for improved compliance over daily topical gels or patches

Market Position:

• Positioned as a convenient alternative to shorter-acting injections
• Competes mainly in the male hypogonadism treatment segment, valued at approximately $2.3 billion globally in 2022 (source: IQVIA)

---

What Are the Market Dynamics Affecting AVEED?

Regulatory Environment

• FDA Approval: AVEED achieved FDA approval based on clinical trials demonstrating sustained testosterone levels with once every 10-week dosing.
• Safety Concerns: Post-marketing safety communicated via FDA boxed warnings, primarily regarding testosterone's potential to increase cardiovascular risks and erythrocytosis.
• Market Withdrawals: In 2020, Teva Pharmaceuticals, the manufacturer of AVEED, voluntarily withdrew the product from the U.S. market citing manufacturing issues, which remains a critical barrier to growth.

Competitive Landscape

Competitor	Formulation	Dosing Interval	Market Share (2022)	Approximate Sales (USD)	Notes
AndroGel (AbbVie)	Gel	Daily	45%	$1.0B	Most widely prescribed TRT
Axiron (Eli Lilly)	Topical solution	Daily	10%	$220M	Declining due to safety/efficacy concerns
TESTIM (Endo)	Gel	Daily	8%	$180M	Generic market presence
Depo-Testosterone (Pfizer)	Injection	Every 2-4 weeks	12%	$250M	Established injectable option
AVEED	Injection	Every 10 weeks	1-2% (pre-2020)	--	Limited post-withdrawal

Implication:

• AVEED’s market share significantly declined post-withdrawal, with other formulations dominating due to established safety profiles and widespread physician familiarity.

Clinical and Safety Considerations

• Efficacy: Demonstrates sustained testosterone levels over 10 weeks, with positive effects on sexual function, mood, and muscle mass.
• Safety Profile: Risks include erythrocytosis, prostate effects, cardiovascular incidents—prompting cautious prescribing.
• Patient Preference: Long-acting injections appeal for convenience but are less used compared to daily topical formulations.

Reimbursement & Market Access

• Coverage: Reimbursement largely aligned with standard TRTs, provided with insurance plans covering injectable formulations.
• Pricing: Premium pricing due to long dosing interval (~$600 per injection), but sensitive to generic competition.

Technological & Innovation Trends

• Shift towards transdermal and novel delivery methods, such as subcutaneous pellets and implants.
• Advances in bioengineering could render current formulations obsolete without innovation.

---

What Is the Financial Trajectory for AVEED?

Historical Sales Performance

Year	Sales (USD)	Notes
2014	~$30 million	Launch year, early adoption
2015	~$50 million	Peak sales period
2016–2019	Declined	Due to market saturation, safety concerns, and limited awareness
2020–2022	$0	Product withdrawn from the market

Forecast Scenarios

Scenario	Assumptions	5-Year Outlook (USD)	Key Drivers
Renewed Market Entry	Manufacturing restored, new clinical data supporting safety	$150–300 million	Regulatory approval, marketing push, clinician acceptance
Limited Reintroduction	Niche patient segment, cautious prescribers	<$50 million	Post-market surveillance, targeted marketing
No Re-entry	Continued market dominance of topical/formulation competitors	<$10 million	Market erosion, patient preference shifts

Revenue Drivers & Challenges

Drivers	Impact	Challenges
Long dosing interval	Differentiation	Market skepticism due to safety concerns
FDA approval & labeling	Validation	Post-market risks and product withdrawal history
Clinical efficacy	Patient adherence	Competition from newer, better-tolerated options
Pricing strategies	Revenue potential	Price sensitivity among payers and patients

---

How Do Policy & Health Systems Influence AVEED’s Market Trajectory?

Regulatory Policies:

• Stringent post-approval safety monitoring essential
• Potential for REMS (Risk Evaluation and Mitigation Strategies) to influence prescribing

Healthcare System Trends:

• Shift toward personalized medicine favors patient-specific formulations
• Cost containment pressures favor generic and lower-cost alternatives

Reimbursement Policies:

• Favor cost-effective, convenient TRTs
• High-cost injectable formulations face reimbursement hurdles unless proven superior

Impact of COVID-19:

• Disrupted supply chains
• Reduced outpatient visits, limiting initial reintroduction

---

Comparison of AVEED Versus Other TRT Formulations

Attribute	AVEED	Gels	Patches	Short-acting injections	Implants
Dosing Frequency	Every 10 weeks	Daily	Daily	Every 2-4 weeks	Every 6–12 months
Administration	Intramuscular	Topical	Transdermal	Intramuscular	Surgical implant
Efficacy	Sustained	Variable	Variable	Fast onset	Long-term
Safety Profile	Blood pressure, erythrocytosis	Skin irritation	Skin reactions	Fluctuations in testosterone levels	Surgical risks
Patient Preference	Moderate	High	Moderate	Moderate	High

---

What Are the Key Success Factors for AVEED’s Market Rebound?

• Regulatory Re-entry approval with clear safety profile reassurances
• Manufacturing assurance to prevent supply disruptions
• Robust clinical data demonstrating safety versus competitors
• Targeted marketing focusing on long-acting convenience
• Strategic partnerships with healthcare providers and payers

---

Key Takeaways

• AVEED’s initial market success was promising but hampered by safety concerns, manufacturing issues, and market competition.
• Post-2020, the drug's removal from the U.S. market limits current revenue, but opportunities remain if reintroduced with improved safety and manufacturing processes.
• Long-acting injectables address adherence issues but face stiff competition from emerging therapies.
• The future of AVEED hinges on regulatory clearance, strategic repositioning, and demonstrating a clear safety advantage.
• Market dynamics favor flexible, patient-centric TRT options, emphasizing the importance of innovation and safety in product development.

---

FAQs

1. Is AVEED currently available in the U.S. market?

No. Teva Pharmaceuticals voluntarily withdrew AVEED from the U.S. market in 2020 due to manufacturing issues, and as of 2023, it remains unavailable.

2. What factors contributed to AVEED’s decline in market share?

Safety concerns, manufacturing challenges, stiff competition from daily topical gels and patches, and limited clinician familiarity contributed significantly.

3. What are the regulatory considerations for reintroducing AVEED?

Reintroduction requires demonstrating manufacturing consistency, safety profile, and possibly new clinical data to satisfy FDA safety standards.

4. How does AVEED compare financially to newer TRT therapies?

Initial sales peaked at approximately $50 million annually pre-withdrawal; future revenues depend on re-entry success, with competition favoring lower-cost, flexible options.

5. What technological advancements could enhance AVEED's market adoption?

Innovations include improved formulations with better safety profiles, extended dosing intervals, and combination therapies tailored for individual patient needs.

---

References

[1] IQVIA. (2022). US revenue and market share report for testosterone therapies.
[2] FDA. (2014). Approval summary for AVEED (Testosterone Undecanoate).
[3] Teva Pharmaceuticals. (2020). Press release on market withdrawal of AVEED.
[4] MarketResearch.com. (2022). Global testosterone replacement therapy market analysis.