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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. Six 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 have been two patent litigation cases 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:	55
Patent Applications:	1,450
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
Germany	602004001893
Costa Rica	7999	METODOS Y COMPOSICIONES FARMACEUTICAS PARA LA OBTENCION CONFIABLE DE NIVELES ACEPTABLES DE TESTOSTERONA EN SUERO
Hong Kong	1069325	Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
World Intellectual Property Organization (WIPO)	2004080383
Serbia	51537	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

AVEED Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AVEED (Testosterone Undecanoate)

Overview of AVEED

AVEED, also known as testosterone undecanoate, is a hormone replacement therapy indicated for the treatment of hypogonadism in adult men. It is formulated as a solution for injection and administered intramuscularly. The drug is used to treat conditions such as primary hypogonadism and hypogonadotropic hypogonadism[1][4].

Regulatory Approval and Launch

AVEED received approval from the U.S. Food and Drug Administration (FDA) in March 2014, following a Phase III clinical study that demonstrated its efficacy and safety. Prior to its approval, the FDA issued a complete response letter outlining the necessary steps, including the implementation of a Risk Evaluation and Mitigation Strategy (REMS) to mitigate risks associated with post-injection reactions[2][4].

Market Indication and Target Population

AVEED is targeted at adult men with hypogonadism, a condition characterized by the reduced production of testosterone. The drug aims to restore normal testosterone levels, addressing symptoms such as infertility, low libido, and fatigue. Given the prevalence of hypogonadism, AVEED has a significant market potential, particularly in regions with aging populations[4].

Clinical Trials and Efficacy

The FDA approval of AVEED was based on a single-arm, open-label, multicenter clinical study involving 130 hypogonadal adult patients. The study showed that AVEED effectively increased and maintained mean serum testosterone levels within the normal range for up to ten weeks after each injection. Approximately 94% of the patients maintained average serum total testosterone concentrations within the normal range[4].

Safety Profile

The clinical trials for AVEED identified several adverse events, including acne, pain at the injection site, rise in prostatic specific antigen (PSA), rise in estradiol, fatigue, irritability, increase in hemoglobin, insomnia, and mood swings. These findings were critical in shaping the REMS and ensuring safe use of the drug[4].

Global Market Presence

While AVEED is marketed by Endo Pharmaceuticals in the U.S., it is known as Nebido and marketed by Bayer Pharma in over 86 countries worldwide. This global presence indicates a broad market reach and potential for significant revenue generation[4].

Financial Trajectory

Revenue Forecasts

The financial trajectory of AVEED is influenced by several factors, including market demand, competition, and regulatory approvals. GlobalData provides a comprehensive NPV model that includes revenue forecasts, operating profit models, and discounted cash flow analyses. These models suggest that AVEED can generate substantial revenue, particularly given its long-acting formulation which reduces the frequency of injections compared to other testosterone replacement therapies[1].

Sales Performance

Historical data on pharmaceutical sales indicates that drugs like AVEED, which address chronic conditions, often see steady growth in the initial years post-launch. Sales typically increase in the first few years as the drug gains market acceptance and then stabilize or fluctuate as the market becomes saturated or new competitors emerge. For example, many drugs in similar therapeutic areas show sales growth up to $10 to $40 million in quarterly sales after about 5 years on the market[3].

Market Competition

The market for testosterone replacement therapies is competitive, with several other products available. However, AVEED's long-acting formulation and the convenience it offers can differentiate it from competitors. The drug's approval and marketing in over 86 countries also provide a competitive edge in the global market[4].

Net Present Value (NPV) Model

GlobalData's NPV model for AVEED includes a forecasted revenue model, patent expiry model, operating profit model, net profit calculation, and discounted cash flow analysis. This comprehensive model helps in deriving the net present value of the drug, which is crucial for strategic decision-making in the pharmaceutical industry. The model provides 17-year drug forecasts, enabling users to analyze and customize valuations for pharmaceutical assets[1].

Risk Evaluation and Mitigation Strategy (REMS)

The REMS for AVEED, which includes a Medication Guide and Elements to Assure Safe Use (ETASU), is a critical component of its market dynamics. This strategy helps mitigate the risks associated with post-injection reactions, ensuring safe use and maintaining regulatory compliance. The implementation of REMS can impact the drug's adoption and revenue, as it may influence prescribing habits and patient compliance[2][5].

Industry Expert Insights

Industry experts emphasize the importance of long-term data and real-world evidence in supporting the financial trajectory of drugs like AVEED. "The long-acting nature of AVEED provides a significant advantage in patient compliance and convenience, which can drive market acceptance and revenue growth," said Ivan Gergel, Executive Vice President of Research and Development and Chief Scientific Officer of Endo Health Solutions[2].

Key Statistics

• Approval Date: March 2014
• Target Population: Adult men with hypogonadism
• Global Presence: Approved in over 86 countries
• Clinical Trial Participants: Over 3,556 subjects worldwide
• Efficacy Rate: Approximately 94% of patients maintained normal testosterone levels[4]

Market Performance Analysis

The sales performance of AVEED can be analyzed in the context of other pharmaceuticals. For instance, quarterly sales data for similar drugs show growth in the initial years, followed by stabilization or fluctuation. AVEED's unique formulation and global market presence suggest it could follow a similar trajectory, with potential for significant revenue generation in the long term[3].

"Most other AM drugs reached between $5 and $10 million in quarterly sales after 1–2 years and up to $10 to $40 million in quarterly sales after about 5 years on the market."[3]

Conclusion

AVEED's market dynamics and financial trajectory are influenced by its regulatory approval, clinical efficacy, safety profile, and global market presence. The drug's long-acting formulation and the implementation of a REMS strategy are key factors in its market acceptance and revenue growth. As the pharmaceutical market continues to evolve, AVEED is positioned to remain a significant player in the testosterone replacement therapy segment.

Key Takeaways

• Regulatory Approval: AVEED was approved by the FDA in March 2014 with a REMS to mitigate post-injection risks.
• Clinical Efficacy: The drug effectively maintains normal testosterone levels in hypogonadal men.
• Global Presence: AVEED is approved in over 86 countries, marketed by Endo Pharmaceuticals in the U.S. and Bayer Pharma globally.
• Financial Trajectory: The drug is expected to show steady revenue growth, influenced by its long-acting formulation and market acceptance.
• Market Competition: AVEED competes in a crowded market but stands out due to its convenience and global reach.

FAQs

Q: What is AVEED used for?

AVEED is used for the treatment of hypogonadism in adult men, specifically for conditions such as primary hypogonadism and hypogonadotropic hypogonadism.

Q: When was AVEED approved by the FDA?

AVEED was approved by the FDA in March 2014.

Q: What is the unique feature of AVEED compared to other testosterone replacement therapies?

AVEED is a long-acting testosterone undecanoate injection, which reduces the frequency of injections compared to other therapies.

Q: What are the common adverse events associated with AVEED?

Common adverse events include acne, pain at the injection site, rise in PSA, rise in estradiol, fatigue, irritability, increase in hemoglobin, insomnia, and mood swings.

Q: How widely is AVEED available globally?

AVEED is approved and marketed in over 86 countries worldwide, with Endo Pharmaceuticals handling the U.S. market and Bayer Pharma managing the global market outside the U.S.

Sources

1. GlobalData, "Net Present Value Model: Aveed," November 24, 2022.
2. PR Newswire, "Endo Pharmaceuticals Provides Regulatory Update On AVEED™ Testosterone Undecanoate Injection," May 30, 2013.
3. NCBI, "MARKET PERFORMANCE ANALYSIS - Antimicrobial Drugs," accessed December 17, 2024.
4. Clinical Trials Arena, "Aveed (testosterone undecanoate) for the Treatment of Men with Hypogonadism," March 14, 2014.
5. Endo Pharmaceuticals, "Endo Pharmaceuticals Provides Regulatory Update On AVEED™ Testosterone Undecanoate Injection," May 30, 2013.