TESTODERM Drug Patent Profile

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

Testoderm is a drug marketed by Alza and is included in two NDAs.

The generic ingredient in TESTODERM 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

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

Summary for TESTODERM

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	73
Patent Applications:	4,548
DailyMed Link:	TESTODERM at DailyMed

US Patents and Regulatory Information for TESTODERM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alza	TESTODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	019762-001	Oct 12, 1993		DISCN	No	No
Alza	TESTODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	019762-002	Oct 12, 1993		DISCN	No	No
Alza	TESTODERM TTS	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020791-001	Dec 18, 1997		DISCN	No	No

Expired US Patents for TESTODERM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alza	TESTODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	019762-002	Oct 12, 1993	4,704,282
Alza	TESTODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	019762-001	Oct 12, 1993	4,704,282
Alza	TESTODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	019762-002	Oct 12, 1993	4,867,982
Alza	TESTODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	019762-002	Oct 12, 1993	4,725,439

EU/EMA Drug Approvals for TESTODERM

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	Withdrawn	no	no	no	2006-07-28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

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2161073	TRANSDERMAL THERAPEUTIC SYSTEMS
Germany	3687067
Italy	1199891	SISTEMA TERAPEUTICO TRANSDERMICO CON CARATTERISTICHE DI EROGAZIONI MIGLIORATE
France	2571623	DISPOSITIF THERAPEUTIQUE TRANSDERMIQUE

TESTODERM Market Analysis and Financial Projection Experimental

Transdermal Drug Delivery Systems: Market Dynamics and Financial Trajectory for Testoderm

Introduction

Transdermal drug delivery systems have revolutionized the way medications are administered, offering a non-invasive and efficient method of drug delivery. One of the key products in this market is Testoderm, a transdermal testosterone patch. Here, we will delve into the market dynamics and financial trajectory of the transdermal drug delivery system market, with a focus on Testoderm and similar hormone replacement therapies.

Market Size and Growth

The global transdermal drug delivery system market is experiencing significant growth. As of 2023, the market size was estimated at USD 66.20 billion and is projected to grow at a compound annual growth rate (CAGR) of 11.9% from 2024 to 2030, reaching USD 145.04 billion by 2030[1].

Drivers of Market Growth

Several factors are driving the growth of the transdermal drug delivery system market:

Increasing Prevalence of Chronic Diseases

The rising incidence of chronic diseases such as diabetes, cardiovascular diseases, and hormonal imbalances is a major driver. Traditional oral drug delivery methods often suffer from lower potency due to first-pass metabolism by the liver, making transdermal delivery a preferred option[1].

Demand for Non-Invasive Drug Delivery

There is a growing demand for non-invasive drug delivery methods, which transdermal patches effectively fulfill. This preference is driven by patient comfort and the ease of administration[2].

Technological Advancements

Advancements in technology have enabled the development of more efficient and patient-friendly transdermal delivery systems. This includes the development of various types of patches such as drug-in-adhesive patches, matrix patches, and micro needle patches[2].

Segmental Overview

By Type

The transdermal drug delivery system market is segmented into transdermal patches and transdermal semisolids. Transdermal patches, which include products like Testoderm, held the largest share of the market in recent years and are expected to continue growing at a high CAGR[2].

By Application

The hormonal applications segment, which includes testosterone replacement therapy, is expected to grow exponentially. Transdermal hormone patches, such as Testoderm, have become popular due to their ease of use and sustained-release features[1].

By End User

The market is also segmented by end user, with hospitals and clinics holding the highest share. However, the home care settings segment is expected to register the highest CAGR during the forecast period, indicating a shift towards self-administration of drugs[2].

Regional Analysis

North America

North America dominated the transdermal drug delivery system market in 2023, driven by factors such as patent expirations, significant investments by market entrants, and favorable reimbursement scenarios. The U.S. accounted for the largest share in this region due to its advanced healthcare infrastructure and high prevalence of chronic diseases[1].

Asia Pacific

The Asia Pacific region is expected to grow the fastest during the forecast period, driven by growing healthcare spending, evolving healthcare infrastructure, and high research and development intensity in countries like China and India[1].

Financial Trajectory for Testoderm

Given the growth trends in the transdermal drug delivery system market, products like Testoderm are poised for significant financial growth.

Market Size and Revenue

The global transdermal drug delivery system market, which includes hormone replacement therapies like Testoderm, is expected to reach substantial revenues. For instance, the market size was valued at USD 33.32 billion in 2023 and is projected to reach USD 49.60 billion by 2032, growing at a CAGR of 4.52%[4].

Segment Growth

The hormonal applications segment, which includes testosterone replacement therapy, is expected to grow exponentially. This growth is driven by the increasing prevalence of conditions requiring hormone replacement therapy, such as menopause and diabetes[1].

Competitive Landscape

The market is competitive, with key players such as GlaxoSmithKline, Novartis, and Johnson & Johnson. These companies are investing heavily in research and development to enhance their product portfolios and technological capabilities[4].

Key Takeaways

• Market Growth: The transdermal drug delivery system market is expected to grow significantly, driven by the increasing prevalence of chronic diseases and demand for non-invasive drug delivery methods.
• Segmental Growth: The hormonal applications segment, including testosterone replacement therapy, is expected to grow exponentially.
• Regional Dominance: North America currently dominates the market, but the Asia Pacific region is expected to grow the fastest.
• Financial Trajectory: Products like Testoderm are expected to see substantial revenue growth due to the overall market trends.

FAQs

What is the projected market size of the transdermal drug delivery system market by 2030?

The global transdermal drug delivery system market is expected to reach USD 145.04 billion by 2030, growing at a CAGR of 11.9% from 2024 to 2030[1].

Which segment is expected to grow the fastest in the transdermal drug delivery system market?

The hormonal applications segment, which includes testosterone replacement therapy, is expected to grow exponentially during the forecast period[1].

What are the key drivers of the transdermal drug delivery system market?

The key drivers include the increasing prevalence of chronic diseases, demand for non-invasive drug delivery methods, and technological advancements[1][2].

Which region is expected to grow the fastest in the transdermal drug delivery system market?

The Asia Pacific region is expected to grow the fastest during the forecast period, driven by growing healthcare spending and evolving healthcare infrastructure[1].

What is the competitive landscape like in the transdermal drug delivery system market?

The market is competitive, with key players investing heavily in research and development to enhance their product portfolios and technological capabilities[4].

Sources

1. Grand View Research: Transdermal Drug Delivery System Market Size Report, 2030
2. GlobeNewswire: Transdermal Drug Delivery System Market worth $8.41 Billion by 2027
3. Maximize Market Research: Transdermal Drug Delivery Systems Market- Industry Analysis 2029
4. Zion Market Research: Transdermal Drug Delivery System Market Size, Share, Growth and Forecast to 2032