FORTESTA Drug Patent Profile

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

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

The generic ingredient in FORTESTA 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 Fortesta

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

Summary for FORTESTA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	3
Patent Applications:	4,278
Drug Prices:	Drug price information for FORTESTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FORTESTA
What excipients (inactive ingredients) are in FORTESTA?	FORTESTA excipients list
DailyMed Link:	FORTESTA at DailyMed

See drug prices for FORTESTA

See drug sales revenues for FORTESTA

Recent Clinical Trials for FORTESTA

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

Sponsor	Phase
Endo Pharmaceuticals	Phase 4
Johns Hopkins University	Phase 4
Endo Pharmaceuticals	Phase 3

See all FORTESTA clinical trials

Paragraph IV (Patent) Challenges for FORTESTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FORTESTA	Gel	testosterone	10 mg/actuation	021463	1	2012-08-14

US Patents and Regulatory Information for FORTESTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	FORTESTA	testosterone	GEL, METERED;TRANSDERMAL	021463-001	Dec 29, 2010		DISCN	Yes	No

Expired US Patents for FORTESTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	FORTESTA	testosterone	GEL, METERED;TRANSDERMAL	021463-001	Dec 29, 2010
Endo Operations	FORTESTA	testosterone	GEL, METERED;TRANSDERMAL	021463-001	Dec 29, 2010

EU/EMA Drug Approvals for FORTESTA

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 FORTESTA

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1510213	Systèmes comprenant de la testostérone améliorants la pénétration et reduisants les irritations (Penetration enhancing and irritation reducing systems comprising testosterone)
European Patent Office	1030668
Spain	2318233

FORTESTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FORTESTA

Introduction to FORTESTA

FORTESTA is a prescription medication containing testosterone, specifically designed for replacement therapy in males with conditions associated with a deficiency or absence of endogenous testosterone. It is one of the key players in the testosterone gel market, which is growing steadily due to increasing demand for testosterone replacement therapies.

Market Size and Growth

The global testosterone gel market, within which FORTESTA operates, was valued at USD 1.81 billion in 2022 and is projected to reach USD 2.96 billion by 2030, growing at a CAGR of 6.3% from 2023 to 2030[1].

Segmentation and Distribution

The testosterone gel market is segmented based on type, dosage, application, and distribution channel. FORTESTA, as a 2% testosterone gel, falls under the 2% solution category. It is primarily used for treating primary hypogonadism, hypogonadotropic hypogonadism, and late-onset hypogonadism. The product is distributed through hospital pharmacies and retail pharmacies, with North America holding the largest market share due to high government approval rates and the availability of several testosterone gel products in the region[1].

Key Growth Factors

Several factors contribute to the growth of the market for FORTESTA:

• Increasing Prevalence of Male Hypogonadism: The rising number of men diagnosed with hypogonadism drives the demand for testosterone replacement therapies.
• Obesity and Related Health Issues: Obesity is linked to hypogonadism, and the increasing prevalence of obesity further boosts the adoption of testosterone gels like FORTESTA[1].

Product Features and Safety

FORTESTA is distinguished by its unique formulation and administration instructions. It is applied topically once daily, with a starting dose of 40 mg of testosterone (4 pump actuations). The dose can be adjusted between 10 mg and 40 mg based on serum testosterone levels[3].

Safety Considerations

• Cancer Patients: FORTESTA should be used with caution in cancer patients at risk of hypercalcemia.
• Cardiovascular, Renal, or Hepatic Disease: Patients with these conditions should be monitored for fluid retention and other complications.
• Thyroid Function: FORTESTA may decrease thyroxine-binding globulin concentrations, although free thyroid hormone levels remain unchanged[3].

Competitive Landscape

The market for testosterone gels is competitive, with several products available, including Androgel, Testim, and generic versions. The launch of the authorized generic version of FORTESTA by Endo International plc has expanded access to this therapy, potentially increasing market share[4].

Financial Performance of Key Players

While the financial performance of FORTESTA itself is not separately reported, the companies involved in its distribution and promotion provide insights into the broader market dynamics.

Endo International plc

Endo International, which promotes and distributes FORTESTA, has seen fluctuations in its financial performance. However, the launch of the authorized generic version of FORTESTA has been a strategic move to maximize the value of the FORTESTA franchise[4].

Fortrea Holdings Inc.

Although Fortrea Holdings Inc. is not directly involved in the distribution of FORTESTA, its financial reports provide a broader context of the healthcare and pharmaceutical industry. Fortrea's revenues and adjusted EBITDA have shown variability, with significant changes in their financial metrics over the past few years. For instance, in the second quarter of 2024, Fortrea reported revenues of $662.4 million and an adjusted EBITDA of $55.2 million, reflecting the dynamic nature of the industry[5].

Revenue and Market Share

The specific revenue generated by FORTESTA is not publicly disclosed, but it contributes to the overall growth of the testosterone gel market. The introduction of the authorized generic version has likely increased its market share by making the product more accessible to a wider audience[4].

Future Outlook

The future outlook for FORTESTA and the testosterone gel market is positive, driven by increasing demand for testosterone replacement therapies. The market is expected to continue growing, with North America remaining a dominant region due to high government approval rates and the prevalence of conditions requiring testosterone therapy[1].

Challenges and Opportunities

Challenges

• Regulatory Scrutiny: Continuous monitoring and adherence to regulatory guidelines are crucial.
• Safety Concerns: Long-term safety data, especially in geriatric patients, is a concern that needs to be addressed[3].

Opportunities

• Technological Advancements: Innovations like Ferring Advanced Skin Technology (FAST) can enhance the absorption and efficacy of testosterone gels, creating growth opportunities[1].
• Expanding Distribution Channels: Increasing availability through both hospital and retail pharmacies can further boost market penetration.

Key Takeaways

• The global testosterone gel market is growing, driven by increasing prevalence of male hypogonadism and related health issues.
• FORTESTA, as a 2% testosterone gel, is a significant player in this market, with a strong presence in North America.
• The product's unique formulation and authorized generic version have expanded its accessibility.
• Continuous regulatory compliance and addressing safety concerns are essential for long-term success.
• Technological advancements and expanding distribution channels offer future growth opportunities.

FAQs

What is FORTESTA used for?

FORTESTA is used for replacement therapy in males with conditions associated with a deficiency or absence of endogenous testosterone, such as primary hypogonadism, hypogonadotropic hypogonadism, and late-onset hypogonadism[3].

How is FORTESTA administered?

FORTESTA is applied topically once daily, with a starting dose of 40 mg of testosterone (4 pump actuations), and can be adjusted based on serum testosterone levels[3].

What are the safety considerations for FORTESTA?

FORTESTA should be used with caution in cancer patients at risk of hypercalcemia and in patients with cardiovascular, renal, or hepatic disease. It may also affect thyroid function and blood glucose levels[3].

Who distributes and promotes FORTESTA?

FORTESTA is distributed by Qualitest and promoted by Endo Pharmaceuticals Inc.[4].

What is the projected growth of the testosterone gel market?

The global testosterone gel market is projected to grow at a CAGR of 6.3% from 2023 to 2030, reaching USD 2.96 billion by 2030[1].