TESTODERM TTS Drug Patent Profile

When do Testoderm Tts patents expire, and when can generic versions of Testoderm Tts launch?

Testoderm Tts is a drug marketed by Alza and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Testoderm Tts

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

Summary for TESTODERM TTS

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	73
Patent Applications:	4,087
DailyMed Link:	TESTODERM TTS at DailyMed

US Patents and Regulatory Information for TESTODERM TTS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alza	TESTODERM TTS	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020791-001	Dec 18, 1997		DISCN	No	No

Expired US Patents for TESTODERM TTS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alza	TESTODERM TTS	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020791-001	Dec 18, 1997
Alza	TESTODERM TTS	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020791-001	Dec 18, 1997

EU/EMA Drug Approvals for TESTODERM TTS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Warner Chilcott UK Ltd.	Intrinsa	testosterone	EMEA/H/C/000634 Intrinsa 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	Withdrawn	no	no	no	2006-07-28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/000630 Livensa 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	Withdrawn	no	no	no	2006-07-28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 TESTODERM TTS

See the table below for patents covering TESTODERM TTS around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	90687	DOSAGE FORM FOR COADMINISTERING DRUG AND PERCUTANEOUS ABSORPTION ENHANCER
Australia	7954582
Japan	S57154122	ADMINISTRATION VEHICLE FOR COADMINISTRATION OF DRUG AND PERCUTANEOUS ABSORPTION PROMOTING AGENT
United Kingdom	2093694	DOSAGE FORM FOR COADMINISTERING DRUG AND PERCUTANEOUS ABSORPTION ENHANCER

TESTODERM TTS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Testoderm TTS

Introduction

Testoderm TTS, a transdermal testosterone delivery system, is a significant player in the hormone replacement therapy market, particularly for males with hypogonadism. This article delves into the market dynamics and financial trajectory of Testoderm TTS, exploring its usage, market status, and the broader financial implications of transdermal drug delivery systems (TDDS).

Market Overview of Transdermal Testosterone Delivery Systems

The market for transdermal testosterone delivery systems is robust and growing, driven by the increasing demand for hormone replacement therapies. Testoderm TTS, along with other products like Androderm and Testim, caters to this demand by providing continuous testosterone delivery through the skin[1][5].

Usage and Indications

Testoderm TTS is designed to deliver testosterone continuously for 24 hours following application to intact, non-scrotal skin. It is primarily used for testosterone replacement therapy in males with hypogonadism, a condition characterized by low levels of testosterone. The system ensures a steady and controlled release of testosterone, mimicking the body's natural production[1][4].

Market Status

Testoderm TTS is a prescription-only medication, indicating its regulated market status. The product is manufactured by companies such as Watson Labs and is available in various strengths to accommodate different patient needs. The prescription status ensures that the product is used under medical supervision, which can impact its market dynamics and financial performance[1].

Financial Trajectory

Revenue and Market Size

The transdermal drug delivery market, including products like Testoderm TTS, has seen significant growth over the years. This market segment represents a multi-billion dollar industry, with annual sales exceeding $1 billion for certain products like transdermal fentanyl. The success of these products is attributed to their convenience, efficacy, and patient compliance[2].

Competitive Landscape

The market for transdermal testosterone delivery systems is competitive, with several products available, including Androderm, Testim, and Striant. Each product has its unique delivery mechanism, such as gels, patches, or buccal systems, which cater to different patient preferences and needs. This competition drives innovation and pricing strategies, influencing the financial trajectory of Testoderm TTS[1][5].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of Testoderm TTS. Regulatory bodies like the FDA and EMA set stringent standards for the development, production, and approval of TDDS. Compliance with these regulations can be costly but is essential for maintaining market approval and ensuring patient safety. The guidelines encompass quality requirements, pharmaceutical development, manufacturing processes, and bioequivalence testing, all of which impact the financial investment required for these products[5].

Patient Compliance and Preference

Patient compliance is a key factor in the financial success of Testoderm TTS. The convenience of transdermal delivery systems, which eliminate the need for daily injections or oral medications, enhances patient adherence. However, skin irritation and other adverse effects can affect patient preference and compliance, potentially impacting sales and revenue[2].

Technological Advancements

Technological advancements in TDDS, such as iontophoresis, sonophoresis, and microneedles, are enhancing the delivery efficiency and reducing the side effects of these systems. These innovations can improve the market position and financial performance of Testoderm TTS by offering better therapeutic outcomes and improved patient comfort[5].

Challenges and Limitations

Skin Permeability and Irritation

One of the significant challenges in the development and use of TDDS like Testoderm TTS is skin permeability and irritation. The stratum corneum acts as a barrier, limiting the penetration of many drugs. Additionally, skin irritation is a common adverse effect, which can lead to discontinuation of therapy. These factors can affect the market dynamics and financial performance by increasing development costs and reducing patient compliance[2][5].

Regulatory Hurdles

The regulatory approval process for TDDS is rigorous and time-consuming. The need to establish bioequivalence, conduct extensive safety and efficacy trials, and comply with quality standards can delay market entry and increase development costs. These regulatory hurdles can impact the financial trajectory by delaying revenue generation and increasing investment requirements[5].

Future Outlook

Growing Demand for Hormone Replacement Therapies

The demand for hormone replacement therapies, including testosterone replacement, is expected to grow due to an aging population and increasing awareness of hypogonadism. This growing demand is likely to drive the sales and revenue of Testoderm TTS and other similar products[1].

Innovations in Delivery Systems

Advancements in TDDS technology, such as the use of nanotechnology and hyaluronic-based systems, are expected to improve the efficacy and safety of these products. These innovations can enhance patient compliance and preference, contributing to a positive financial trajectory for Testoderm TTS[5].

Key Takeaways

• Market Growth: The market for transdermal testosterone delivery systems is growing, driven by increasing demand for hormone replacement therapies.
• Competitive Landscape: The market is competitive with several products available, each with unique delivery mechanisms.
• Regulatory Environment: Compliance with regulatory standards is crucial for market approval and patient safety.
• Patient Compliance: Convenience and efficacy of TDDS enhance patient compliance, but skin irritation remains a challenge.
• Technological Advancements: Innovations in TDDS technology are expected to improve therapeutic outcomes and patient comfort.

FAQs

What is Testoderm TTS used for?

Testoderm TTS is used for testosterone replacement therapy in males with hypogonadism, delivering testosterone continuously through the skin.

How does Testoderm TTS work?

Testoderm TTS works by delivering testosterone through a transdermal patch applied to intact, non-scrotal skin, providing a steady and controlled release of testosterone.

What are the common side effects of Testoderm TTS?

Common side effects include skin irritation, redness, and itching at the application site. Cardiovascular events, such as myocardial infarction or stroke, have also been reported in some cases[1][2].

How does the regulatory environment impact Testoderm TTS?

The regulatory environment sets stringent standards for development, production, and approval, which can be costly but are essential for ensuring patient safety and maintaining market approval.

What are the future prospects for Testoderm TTS?

The future outlook is positive, driven by growing demand for hormone replacement therapies and innovations in TDDS technology that are expected to improve efficacy and safety.

Sources

1. Pharmacompass: Testoderm TTS - Uses, DMF, Dossier, Manufacturer, Supplier.
2. University of Bath: Transdermal Drug Delivery.
3. CDC: 2010 nhamcs micro-data file documentation.
4. FDA: 20791 Testodem TTS 5mg per Day Administrative Documents.
5. MDPI: The Design Features, Quality by Design Approach, Characterization and Regulatory Guidance of Transdermal Drug Delivery Systems.