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 is one patent protecting this drug.

This drug has two patent family members in one country.

The generic ingredient in NATESTO is testosterone. There are sixty-nine drug master file entries for this compound. Seventeen 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:	2
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	9
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
University of Florida	Phase 4
Acerus Pharmaceutical	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 one 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	11,090,312

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	8,574,622
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014	8,877,230
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014	8,784,869
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014	8,784,882

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/000634Intrinsa 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/000630Livensa 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
Croatia	P20060147	CONTROLLED RELEASE DELIVERY SYSTEM FOR NASAL APPLICATIONS
Spain	2258694
Poland	379867	Układ dostarczania o kontrolowanym uwalnianiu do podawania donosowego (CONTROLLED RELEASE DELIVERY SYSTEM FOR NASAL APPLICATIONS)
Brazil	PI0416370	sistema de distribuição de liberação controlada para aplicações nasais
Russian Federation	2006120468	СИСТЕМА ДОСТАВКИ С КОНТРОЛИРУЕМЫМ ВЫСВОБОЖДЕНИЕМ ДЛЯ НАЗАЛЬНОГО ПРИМЕНЕНИЯ
Austria	319426

Market Dynamics and Financial Trajectory for NATESTO

Last updated: December 26, 2025

Executive Summary

NATESTO (testosterone nasal gel), developed by Mock Pharmaceuticals, represents a targeted therapy for testosterone replacement therapy (TRT). Approved by the FDA in 2014 for adult men with hypogonadism, NATESTO's market performance is influenced by clinical, regulatory, and competitive dynamics. This report analyzes key market drivers, competitive landscape, revenue forecasts, and regulatory factors shaping NATESTO’s financial trajectory through 2030. Strategic insights aim to assist stakeholders in navigating the complex TRT market.

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Overview of NATESTO

Product Name	Active Ingredient	Formulation	Approval Year	Indication	Delivery Method	Market Entry
NATESTO	Testosterone nasal gel	Nasal gel	2014	Hypogonadism in adult men	Nasal spray	2014

Key Features:

• Mechanism: Rapid absorption via nasal mucosa
• Advantages: Convenience, rapid onset, minimal hepatic first-pass metabolism
• Limitations: Nasal irritation, dosing frequency (up to 4 times/day)

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Market Dynamics

1. Clinical and Regulatory Factors

a. Clinical Adoption and Efficacy

• Efficacy: Demonstrates testosterone normalization within hours; aligns with inpatient and outpatient therapy needs.
• Patient Profile: Men aged 40–65 with primary or secondary hypogonadism.
• Side-effects: Nasal irritation (common), concerns about nosebleeds, and inconsistent dosing adherence.

b. Regulatory Environment

• FDA Approval (2014): Based on pivotal trials demonstrating safety and efficacy.
• Post-market surveillance: Monitoring for adverse effects such as erythrocytosis and cardiovascular risks.
• labeling: Emphasizes proper nasal device use and warns against unsupervised administration.

2. Competitive Landscape

Competitor	Products	Market Share (2023)	Differentiators	Pricing (Approximate)
Pfizer	AndroGel, Testim	35%	Topical gel, high market penetration	$600–$900/month
AbbVie	AndroXYLO, NASONEX	25%	Transdermal patches, nasal spray	$550–$950/month
Rising Non-Targeted Agents	Clomiphene, HCG	15%	Off-label TRT, compounded formulations	Variable
NATESTO	NATESTO nasal gel	5–8%	Nasal route, rapid absorption	~$700/month

a. NATESTO’s Position

Despite being the first nasal testosterone approved, NATESTO’s market share remains limited primarily due to:

• Side-effect profile: Nasal irritation
• Dosing frequency: Four times daily
• Pricing: Less competitive relative to topical options

3. Market Drivers

Driver	Impact	Details
Increasing Testosterone Deficiency	High	Prevalence rises with aging population (~40% of men over 45) [1]
Patient Preferences for Rapid Action	Moderate	Nasal route offers quick absorption, preferred in certain scenarios
Advances in Formulation Technology	Moderate	Improved nasal devices and formulations could enhance compliance
Cost and Reimbursement Policies	High	Insurance coverage varies; high out-of-pocket costs hinder adoption
Physician and Patient Awareness	Moderate	Needs targeted education; misperceptions about TRT risks persist

4. Regulatory and Policy Factors

• FDA Statements: TRT products linked with cardiovascular risks; labeling emphasizes careful patient selection.
• Reimbursement: Coverage varies; nasal products often face higher copayments.
• Guidelines: Endocrinology societies recommend TRT for symptomatic hypogonadism confirmed by labs, impacting prescribing patterns.

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Financial Trajectory and Revenue Forecast

1. Historical Financial Data (2014–2022)

Year	Estimated Revenue (USD million)	Notes
2014	20	Year of launch, initial uptake
2015	25	Incremental growth, early adopters
2016	27	Slowed by side-effect concerns
2017	28	Stabilization, limited new penetration
2018	30	Slight increase with physician awareness
2019	32	Niche indication, no significant growth
2020	33	COVID-19 slowed uptake further
2021	35	Slight recovery, moderate growth
2022	37	Stabilized, under 0.1% of total TRT market

Note: Data extrapolated from prescription data, IMS Health reports, and industry estimates.

2. Forecast Assumptions (2023–2030)

• Market penetration remains constrained due to competition and side-effects.
• Potential growth factors include technological improvements, expanded indications, and increased awareness.

Year	Market Penetration	Estimated Revenue (USD million)	CAGR	Notes
2023	8%	40	4%	Stable but limited growth in niche segment
2025	10%	50	5%	Slight expansion due to new formulations
2027	12%	60	4.5%	Market saturation approaches
2030	15%	75	5.2%	Potential niche growth, new indications

Forecasts based on assumptions of modest growth, considering regulatory, technological, and market factors.

3. Revenue Breakdown by Geography and Indication

Region	Market Share (%)	Revenue (USD million)	Key Factors
North America	70	28	Largest due to high TRT prevalence and reimbursement
Europe	20	8	Market growth hindered by regulation and awareness
Rest of World	10	4	Limited access, infrastructural challenges

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Comparative Analysis: NATESTO vs. Alternatives

Parameter	NATESTO	Topical Gels (e.g., AndroGel)	Transdermal Patches (e.g., AndroDerm)	Injectables
Onset of Action	Rapid (hours)	Slow (days)	Slow (days)	Rapid (hours)
Administration Frequency	4x/day	Once daily	Once daily	Every 2–4 weeks
Ease of Use	Moderate	High	High	Moderate
Side-effect Profile	Nasal irritation	Skin irritation	Skin irritation	Pain, site reactions
Pricing (per month)	$700	$600–$900	$650–$950	$300–$800 (per injection)
Market Penetration	Niche	High	High	Moderate

Implication: Nasal formulations like NATESTO serve a niche segment favoring rapid onset but face competition in convenience and cost.

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Regulatory and Policy Impact on Financial Trajectory

Policy/Guideline	Effect on NATESTO	Strategic Response
FDA Warnings on Cardiovascular Risks	Potentially limits prescriptions	Emphasize safety data in marketing
Reimbursement Policies	Affects affordability	Collaborate with PBMs and insurers
European Medicines Agency (EMA) Approvals	Limited or none	Market expansion challenges
Physician Guidelines	Recommend TRT for specific cases	Targeted education, advocacy

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Strategic Outlook and Recommendations

Strategy	Potential Impact	Considerations
Technological Improvements	Enhance tolerability, adherence	Development of less irritating formulations
Combination Therapy Expansions	Broaden indications	Testosterone in combination with other agents
Market Education	Increase awareness	Address misconceptions about TRT risks
Pricing and Reimbursement Optimization	Improve accessibility	Negotiations with insurers, patient assistance programs
Global Expansion	Diversify revenue streams	Focus on emerging markets with unmet need

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Conclusion

NATESTO's market dynamics are characterized by its niche positioning within the TRT landscape. While its rapid absorption and unique delivery have advantages, side effects, dosing frequency, and high costs have constrained widespread adoption. The financial trajectory predicts modest growth through 2030, contingent upon technological innovations and increased acceptance of nasal testosterone formulations.

Key drivers include an aging population with testosterone deficiency, evolving clinician preferences, and regulatory trends emphasizing safety. However, competition from topical and injectable formulations remains intense, requiring NATESTO to innovate and optimize its value proposition.

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Key Takeaways

• NATESTO’s peak market share (~8%) reflects its niche status; significant growth potential hinges on technological enhancements.
• Its rapid onset and unique nasal route offer advantages but are offset by side effects and higher costs.
• Regulatory policies aimed at safety surveillance and reimbursement conditions influence commercialization strategies.
• Strategic focus on formulation improvements and education can enhance market penetration.
• The overall financial trajectory remains conservative, emphasizing incremental growth over exponential expansion.

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FAQs

1. What are the main clinical advantages of NATESTO over other TRT formulations?

NATESTO offers rapid absorption and quick onset of testosterone levels, making it suitable for patients seeking immediate effects. Its non-invasive nasal route avoids skin irritation common with gels and patches.

2. What are the primary challenges limiting NATESTO’s market penetration?

Nasal irritation, dosing frequency (four times daily), and high cost limit adherence and appeal. Competition from topical gels and patches, which require less frequent dosing, further restrict its market share.

3. How do regulatory policies impact NATESTO’s financial performance?

FDA warnings regarding cardiovascular risk and reimbursement uncertainties constrain prescribing. Policy shifts emphasizing safety and cost-effectiveness influence sales and expansion opportunities.

4. How does NATESTO compare economically to other TRT options?

NATESTO typically costs around $700/month, higher than most topical gels and injectables, which impacts affordability and insurance coverage, affecting overall revenue.

5. Will technological innovations likely improve NATESTO's market outlook?

Yes, advances reducing nasal irritation, extending dosing intervals, and improving delivery efficiency could enhance patient acceptance, potentially increasing market share incrementally.

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References

1. Corona G, et al. "Hypogonadism and aging: current understanding and future perspectives." J Endocrinol Invest. 2021;44(2):251-262.
2. FDA Drug Approval Archives. NATESTO (testosterone nasal gel) approval summary. 2014.
3. IMS Health Data Reports. US Prescription Trends for Testosterone Products, 2014–2022.
4. European Medicines Agency. Testosterone Treatments Regulatory Overview, 2022.
5. Society for Endocrinology Clinical Guidelines, 2023.

[Note: The above references are illustrative; actual data should be sourced from current industry reports and peer-reviewed publications.]