STRIANT Drug Patent Profile

Which patents cover Striant, and when can generic versions of Striant launch?

Striant is a drug marketed by Auxilium Pharms Llc and is included in one NDA.

The generic ingredient in STRIANT 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 Striant

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

Summary for STRIANT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	73
Patent Applications:	5,503
Drug Prices:	Drug price information for STRIANT
What excipients (inactive ingredients) are in STRIANT?	STRIANT excipients list
DailyMed Link:	STRIANT at DailyMed

See drug prices for STRIANT

US Patents and Regulatory Information for STRIANT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Auxilium Pharms Llc	STRIANT	testosterone	TABLET, EXTENDED RELEASE;BUCCAL	021543-001	Jun 19, 2003		DISCN	Yes	No

Expired US Patents for STRIANT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Auxilium Pharms Llc	STRIANT	testosterone	TABLET, EXTENDED RELEASE;BUCCAL	021543-001	Jun 19, 2003
Auxilium Pharms Llc	STRIANT	testosterone	TABLET, EXTENDED RELEASE;BUCCAL	021543-001	Jun 19, 2003

EU/EMA Drug Approvals for STRIANT

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	Withdrawn	no	no	no	2006-07-28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	Withdrawn	no	no	no	2006-07-28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 STRIANT

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	121497	Use of a bioadhesive
World Intellectual Property Organization (WIPO)	0195888
Portugal	1011632
Japan	5411398
Israel	134564
Japan	2004500317
Australia	565354

STRIANT Market Analysis and Financial Projection Experimental

Testosterone Replacement Therapy Market: Focus on STRIANT

Introduction to Testosterone Replacement Therapy (TRT)

Testosterone replacement therapy (TRT) is a medical intervention designed to treat individuals with low levels of testosterone, a hormone crucial for various bodily functions. One of the key products in the TRT market is STRIANT, a buccal testosterone system.

Market Dynamics of TRT

The global TRT market is experiencing significant growth, driven by several key factors:

Increasing Aging Population

The aging population is a major driver, as testosterone levels naturally decline with age. This demographic shift is expected to continue driving demand for TRT products[4].

Growing Prevalence of Hypogonadism

Hypogonadism, a condition characterized by low testosterone levels, is becoming more prevalent due to factors such as unhealthy lifestyles, obesity, and chronic diseases like diabetes and metabolic syndrome. This rise in hypogonadism cases is fueling the demand for TRT[1].

Technological Advancements

Advancements in treatment options, including innovative delivery systems like transdermal patches, gels, and long-acting injections, are enhancing patient convenience and compliance. Products like STRIANT, which offer unique delivery mechanisms, are gaining traction in the market[1].

Product Overview: STRIANT

STRIANT is a buccal testosterone system, meaning it is applied to the upper gum, where it adheres and releases testosterone over a 12-hour period. This delivery method is designed to provide a steady and controlled release of testosterone, mimicking the body's natural production.

Market Share and Revenue

In the TRT market, the buccal segment, which includes products like STRIANT, is part of the broader product landscape that also includes injectables, gels, and patches. While injectables dominated the market share in terms of revenue in 2022, the buccal and other segments are expected to register significant growth due to their convenience and prolonged release mechanisms[1].

Regional Market Analysis

The TRT market is analyzed across several regions, with North America currently holding the largest share due to the strong presence of major key players, a well-developed healthcare infrastructure, and an aging population. However, the Asia-Pacific region is anticipated to witness the highest growth rate during the forecast period, driven by rising medical tourism, developing healthcare infrastructure, and increasing awareness of age-related testosterone deficiency in countries like China and India[1][4].

Competitive Landscape

The TRT market is highly competitive, with several key players such as AbbVie Inc, Besins Healthcare SA, Acerus Pharmaceuticals Corporation, and Amneal Pharmaceuticals Inc. The acquisition of Actient Holdings LLC by Auxilium Pharmaceuticals in 2013 is a notable example of strategic moves to strengthen market presence. This acquisition created a leading urology franchise with a diversified product portfolio, including TRT options like STRIANT[2].

Financial Trajectory

The global TRT market was valued at $1.9 billion in 2022 and is projected to reach $2.9 billion by 2032, growing at a CAGR of approximately 8.9%. This growth is driven by increasing awareness of testosterone deficiency, advancements in treatment options, and the expanding demand from an aging population and those with hypogonadism[1][4].

Revenue and Growth Projections for STRIANT

While specific financial projections for STRIANT are not isolated, the product's unique delivery mechanism and the growing demand for convenient TRT options suggest it will contribute significantly to the overall market growth. The buccal segment, in particular, is expected to register high growth rates due to its prolonged and controlled release of testosterone, which enhances patient compliance and convenience[1].

Challenges and Restraints

Despite the growth potential, the TRT market, including products like STRIANT, faces challenges such as high regulatory scrutiny and safety concerns. There is also a high risk of side effects associated with testosterone therapy, which can impact market growth and product adoption[4].

Key Takeaways

• The global TRT market is driven by an aging population, rising prevalence of hypogonadism, and technological advancements.
• STRIANT, as a buccal testosterone system, offers a unique delivery mechanism that enhances patient convenience and compliance.
• The Asia-Pacific region is expected to be the fastest-growing market for TRT due to developing healthcare infrastructure and increasing awareness.
• The market faces challenges such as high regulatory scrutiny and safety concerns.

Frequently Asked Questions (FAQs)

1. What is the projected growth rate of the global TRT market? The global TRT market is projected to grow at a CAGR of approximately 8.9% from 2022 to 2032[1][4].

2. Which region is expected to dominate the TRT market in the forecast period? North America is expected to maintain its dominance, but the Asia-Pacific region is anticipated to witness the highest growth rate during the forecast period[1][4].

3. What are the key drivers of the TRT market? Key drivers include an increasing aging population, growing prevalence of hypogonadism, and technological advancements in treatment options[1][4].

4. What are the challenges faced by the TRT market? Challenges include high regulatory scrutiny, safety concerns, and the high risk of side effects associated with testosterone therapy[4].

5. Which companies are major players in the TRT market? Major players include AbbVie Inc, Besins Healthcare SA, Acerus Pharmaceuticals Corporation, and Amneal Pharmaceuticals Inc[1].

Sources:

1. Allied Market Research - Testosterone Replacement Therapy Market Size Report, 2032
2. PR Newswire - Auxilium Pharmaceuticals Completes Acquisition Of Actient Holdings LLC
3. GlobeNewswire - Global Substance Abuse Treatment Market to hit $22.8 billion Globally by 2031
4. SkyQuestT - Testosterone Replacement Therapy Market Size (2024-2031)