NATESTO Drug Patent Profile

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

Natesto is a drug marketed by Acerus and is included in one NDA. There are five patents protecting this drug.

This drug has thirty-one patent family members in twenty-two countries.

The generic ingredient in NATESTO 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 Natesto

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

Summary for NATESTO

International Patents:	31
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	9
Patent Applications:	3,560
Drug Prices:	Drug price information for NATESTO
What excipients (inactive ingredients) are in NATESTO?	NATESTO excipients list
DailyMed Link:	NATESTO at DailyMed

See drug prices for NATESTO

Recent Clinical Trials for NATESTO

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

Sponsor	Phase
Southern California College of Optometry at Marshall B. Ketchum University	Phase 2
Acerus Pharmaceutical	Phase 4
University of Florida	Phase 4

See all NATESTO clinical trials

Pharmacology for NATESTO

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

US Patents and Regulatory Information for NATESTO

NATESTO is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014		RX	Yes	Yes			Y
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014		RX	Yes	Yes			Y
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014		RX	Yes	Yes

Expired US Patents for NATESTO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014

EU/EMA Drug Approvals for NATESTO

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 NATESTO

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

Country	Patent Number	Title	Estimated Expiration
Germany	60303854
Austria	319426
Malaysia	131483	CONTROLLED RELEASE DELIVERY SYSTEM OF SEXUAL HORMONES FOR NASAL APPLICATIONS

NATESTO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Natesto

Introduction to Natesto

Natesto is a testosterone nasal gel, the only FDA-approved product of its kind, manufactured by Acerus Pharmaceuticals Corporation. It is designed to treat hypogonadism, a condition where the body does not produce sufficient natural testosterone. Here, we delve into the market dynamics and financial trajectory of Natesto.

Market Drivers and Growth Outlook

The testosterone nasal gels market, led by Natesto, is driven by several key factors:

Prevalence of Hypogonadism

The increasing prevalence of hypogonadism is a significant driver. Approximately 4 to 5 million males in the U.S. are affected by this condition, creating a substantial market opportunity[1][4].

New Product Launches and Collaborations

New product launches and strategic collaborations among market players also contribute to market growth. For instance, Acerus Pharmaceuticals Corporation's collaboration with Hyundai Pharm Co. to launch Natesto in South Korea has expanded the product's global reach[1].

CAGR and Market Forecast

The testosterone nasal gels market is expected to grow at a CAGR of 3% during the forecast period of 2021-2031, indicating steady and sustained growth[1].

Regional Market Dynamics

North American Dominance

The North American region, particularly the U.S. and Canada, dominates the market for Natesto. This is largely due to the presence of Acerus Pharmaceuticals Corporation, the manufacturer of Natesto, and the high prevalence of hypogonadism in this region[1].

Global Expansion

Efforts to expand globally through collaborations, such as the launch in South Korea, are also significant. These initiatives help in tapping into other regional markets and increasing the product's global footprint[1].

Key Segments and Distribution Channels

By Indication

Natesto is primarily used for treating primary hypogonadism and hypogonadotropic hypogonadism. These indications are critical segments driving the demand for the product[1].

By Dosage

The product is available in 5mg and 10mg dosages, catering to different patient needs and preferences[1].

By Distribution Channel

Natesto is distributed through hospital pharmacies, retail pharmacies, and mail order pharmacies. This diverse distribution network ensures wide accessibility of the product[1].

Financial Performance of Acerus Pharmaceuticals

Revenue Growth

Acerus Pharmaceuticals saw a significant increase in revenue following the buyback of the U.S. rights for Natesto from Aytu Biopharma in April 2021. Revenue for the second quarter of 2021 was $0.6 million, a 219% increase from the prior-year period[2].

Gross Profit and EBITDA

The company reported a gross profit of $0.5 million in the second quarter of 2021, compared to a gross loss of $0.1 million in the prior year. However, the EBITDA loss remained significant, at $6.2 million for the fourth quarter of 2021, reflecting ongoing operational and financial challenges[2][5].

Commercial Strategy and Market Share

Acerus has a strong commercial strategy focused on expanding in the U.S. market. The company aims to achieve mid-double-digit market share and over $100 million in net revenue. Total Natesto prescriptions in the U.S. rose by 20% year-over-year in the fourth quarter of 2021, indicating successful execution of this strategy[4][5].

Product Highlights and Competitive Advantage

Efficacy and Safety Profile

Natesto is known for its effective symptom relief, with 90% of men reaching normal testosterone levels. It also has a strong safety profile with low adverse events and maintains sperm parameters within normal ranges, which is a unique advantage over other testosterone replacement therapies[4].

Preferred Formulary Access

Natesto has preferred formulary access with Express Scripts Inc., enhancing its market position and accessibility to patients[4].

Future Growth and Development

Business Development and R&D

Acerus is focused on business development and internal R&D to drive future growth. The company is exploring new opportunities and products to expand its portfolio and strengthen its position in the men’s health specialty pharmaceutical market[4].

Financial Incentives and Market Exclusivity

While not directly related to Natesto, Acerus's acquisition of Orphan Drug designation for other products like AR101 highlights the company's ability to secure financial incentives and potential market exclusivity, which can support overall business growth[3].

Challenges and Risks

Operational and Financial Challenges

Despite revenue growth, Acerus faces significant operational and financial challenges, including EBITDA losses and cash flow management. The company's cash reserves have been impacted by operational expenses and debt repayments[5].

Market Competition

The testosterone replacement therapy market is competitive, and Natesto faces competition from other forms of testosterone therapies. Maintaining market share and expanding the customer base are ongoing challenges[1].

Key Takeaways

• The testosterone nasal gels market, led by Natesto, is expected to grow at a CAGR of 3% by 2031.
• The North American region dominates the market due to the high prevalence of hypogonadism and the presence of Acerus Pharmaceuticals.
• Natesto has a strong efficacy and safety profile, with preferred formulary access.
• Acerus Pharmaceuticals has seen significant revenue growth following the buyback of Natesto rights but faces ongoing operational and financial challenges.
• Future growth is expected through focused business development and internal R&D.

FAQs

What is the growth outlook for the testosterone nasal gels market by 2031?

The testosterone nasal gels market is expected to grow at a CAGR of 3% during the forecast period of 2021-2031[1].

Which region is dominating the testosterone nasal gels market?

The North American region, particularly the U.S. and Canada, dominates the market for testosterone nasal gels due to the high prevalence of hypogonadism and the presence of Acerus Pharmaceuticals[1].

What are the key factors driving demand for Natesto?

The key factors driving demand for Natesto include the rise in the prevalence of hypogonadism and new product launches and collaborations among market players[1].

How has the buyback of Natesto rights impacted Acerus Pharmaceuticals' revenue?

The buyback of the U.S. rights for Natesto from Aytu Biopharma in April 2021 resulted in a 219% increase in revenue for Acerus Pharmaceuticals in the second quarter of 2021 compared to the prior year[2].

What are the unique advantages of Natesto over other testosterone replacement therapies?

Natesto has a strong efficacy and safety profile, with 90% of men reaching normal testosterone levels, low adverse events, and maintenance of sperm parameters within normal ranges[4].

Cited Sources

1. Fact.MR, Testosterone Nasal Gels Market Share, Size & Forecast.
2. Financial Post, Acerus Reports Fiscal 2021 Second Quarter Financial Results.
3. United States Securities and Exchange Commission, Form 10-K.
4. Acerus Pharmaceuticals, Acerus Corporate Deck Nov2020.
5. GlobeNewswire, Acerus Reports Fourth Quarter and Full Year 2021 Financial Results.