TESTIM Drug Patent Profile

When do Testim patents expire, and what generic alternatives are available?

Testim is a drug marketed by Endo Operations and is included in one NDA.

The generic ingredient in TESTIM 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 Testim

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

Summary for TESTIM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	16
Patent Applications:	4,317
Drug Prices:	Drug price information for TESTIM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TESTIM
What excipients (inactive ingredients) are in TESTIM?	TESTIM excipients list
DailyMed Link:	TESTIM at DailyMed

See drug prices for TESTIM

See drug sales revenues for TESTIM

Recent Clinical Trials for TESTIM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Endo Pharmaceuticals	Phase 4
Instituto de Investigacion Sanitaria La Fe	Phase 3
Marianne Andersen	Phase 4

See all TESTIM clinical trials

Pharmacology for TESTIM

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

Paragraph IV (Patent) Challenges for TESTIM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TESTIM	Gel	testosterone	1%	021454	1	2008-08-21

US Patents and Regulatory Information for TESTIM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	AB2	RX	Yes	Yes

Expired US Patents for TESTIM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002

EU/EMA Drug Approvals for TESTIM

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 TESTIM

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	8718404
Malaysia	139721	PHARMACEUTICAL COMPOSITION
South Korea	20050011753
Latvia	13303	PHARMACEUTICAL COMPOSITION
Germany	3690626

Supplementary Protection Certificates for TESTIM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
8703473	91289	Luxembourg		PRODUCT NAME: TESTIM; REGISRATION NO 1768/92

TESTIM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Testim: A Comprehensive Analysis

Introduction

Testim, a topical testosterone gel, is a key player in the testosterone replacement therapy (TRT) market. This article delves into the market dynamics, financial trajectory, and other critical factors influencing the success of Testim.

Global Testosterone Replacement Therapy Market Overview

The global TRT market, in which Testim operates, was valued at around USD 1.4 billion in 2022 and is projected to grow to USD 2.9 billion by 2031, with a Compound Annual Growth Rate (CAGR) of 8.9% during the forecast period of 2024-2031[1].

Market Segmentation

The TRT market is segmented by product type, active ingredients, end users, and region. Testim falls under the topical product type category, which is one of the key segments driving market growth. The market is also segmented by active ingredients, with testosterone being a primary component of Testim[1].

Regional Market Dynamics

North America currently dominates the TRT market, driven by an aging population, increasing awareness of low testosterone levels, well-established healthcare infrastructure, and favorable reimbursement policies. However, the Asia-Pacific region is expected to witness the fastest growth due to rapidly developing medical infrastructure, rising medical tourism, and growing awareness of age-related testosterone deficiency[1].

Product Details and Usage

Testim is indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. It is administered as a topical gel, which is applied daily to the skin, providing a steady release of testosterone[5].

Safety and Adverse Reactions

While Testim is effective, it comes with several potential side effects and safety concerns. These include venous thromboembolic events, cardiovascular risks, hepatic adverse effects, and hypercalcemia. Patients must be closely monitored for these conditions, and treatment should be discontinued if any of these adverse effects occur[5].

Market Drivers

Several factors drive the growth of the TRT market, including:

• Increasing Aging Population: The rise in the aging population contributes significantly to the growth of the TRT market, as age-related conditions such as hypogonadism become more prevalent[1].
• Growing Technological Advancements: Innovations in drug delivery systems and new product developments by leading pharmaceutical companies are key drivers of market growth[1].

Market Restraints

Despite the growth drivers, the TRT market faces several restraints:

• High Regulatory Scrutiny and Safety Concerns: Strict regulatory oversight and concerns about the safety of testosterone replacement therapies can hinder market growth[1].
• High Risk of Side Effects: The potential for serious side effects, such as cardiovascular events and hepatic adverse effects, can deter some patients and healthcare providers from using TRT products like Testim[5].

Financial Trajectory

To understand the financial trajectory of Testim, it is essential to look at the broader TRT market and the specific financial models used for pharmaceutical assets.

Revenue Projections

The global TRT market is expected to grow significantly, with Testim being a part of this growth. The market size is projected to reach USD 2.9 billion by 2031, indicating a robust financial trajectory for TRT products[1].

Net Present Value (NPV) Model

GlobalData's NPV model provides a comprehensive financial analysis for pharmaceutical assets, including drugs like Testim. This model includes revenue forecasts, operating profit models, and discounted cash flow analyses to derive the NPV. Such models help in understanding the quantitative value of Testim and support strategic decision-making in the pharmaceutical industry[2].

Competitive Landscape

The TRT market is competitive, with several products available, including injectables, topical gels like Testim, and other forms. The market is dominated by well-established pharmaceutical companies that invest heavily in research and development to innovate and expand their product portfolios[1].

Future Outlook

The future outlook for Testim and the broader TRT market is promising, driven by increasing demand for hormone replacement therapies. However, it is crucial for manufacturers to address safety concerns and regulatory scrutiny to maintain market growth.

"Rapidly developing medical infrastructure, rising medical tourism, higher spending as well as developing level of awareness among the population in developing nations such as China and India are some of the factors that are attributing the growth in this region."[1]

Key Takeaways

• The global TRT market is expected to grow to USD 2.9 billion by 2031, driven by an aging population and technological advancements.
• Testim, as a topical testosterone gel, is part of this growing market but faces challenges such as regulatory scrutiny and potential side effects.
• The Asia-Pacific region is projected to witness the fastest growth due to developing medical infrastructure and increasing awareness.
• Financial models like the NPV model are crucial for understanding the quantitative value and future financial trajectory of Testim.

FAQs

What is the current market size of the global Testosterone Replacement Therapy market?

The global Testosterone Replacement Therapy market was valued at around USD 1.4 billion in 2022 and is expected to reach USD 2.9 billion by 2031[1].

What are the primary drivers of the TRT market?

The primary drivers include the increasing aging population, growing technological advancements, and rising awareness of low testosterone levels among healthcare providers and patients[1].

What are the potential side effects of using Testim?

Potential side effects include venous thromboembolic events, cardiovascular risks, hepatic adverse effects, and hypercalcemia. Patients must be closely monitored for these conditions[5].

Which region is expected to witness the fastest growth in the TRT market?

The Asia-Pacific region is projected to witness the fastest growth due to rapidly developing medical infrastructure, rising medical tourism, and growing awareness of age-related testosterone deficiency[1].

How does the NPV model help in evaluating pharmaceutical assets like Testim?

The NPV model provides a comprehensive financial analysis, including revenue forecasts, operating profit models, and discounted cash flow analyses, to derive the net present value of pharmaceutical assets. This helps in understanding the quantitative value and supporting strategic decision-making[2].

Sources

1. SkyQuest Technology Consulting Pvt. Ltd. - Testosterone Replacement Therapy Market Size(2024-2031)
2. GlobalData - Net Present Value Model: Testim
3. Boston Consulting Group - The 2024 New Drug Modalities Report
4. Precedence Research - Pharmaceutical Analytical Testing Market Size, Report by 2034
5. Drugs.com - Testim: Package Insert / Prescribing Information