INTRAROSA Drug Patent Profile

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

Intrarosa is a drug marketed by Millicent and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-nine patent family members in thirty-two countries.

The generic ingredient in INTRAROSA is prasterone. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the prasterone profile page.

DrugPatentWatch^® Generic Entry Outlook for Intrarosa

Intrarosa was eligible for patent challenges on November 16, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 7, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for INTRAROSA

International Patents:	59
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	8
Patent Applications:	4,282
Drug Prices:	Drug price information for INTRAROSA
What excipients (inactive ingredients) are in INTRAROSA?	INTRAROSA excipients list
DailyMed Link:	INTRAROSA at DailyMed

See drug prices for INTRAROSA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for INTRAROSA

Constraining patent/regulatory exclusivity:

8,629,129

NDA:

208470

Dosage:

INSERT;VAGINAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for INTRAROSA

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

Sponsor	Phase
Lee's Pharmaceutical Limited	Phase 3
University of Arkansas	Phase 2
AMAG Pharmaceuticals, Inc.	Phase 2

See all INTRAROSA clinical trials

US Patents and Regulatory Information for INTRAROSA

INTRAROSA is protected by three US patents.

This potential generic entry date is based on patent 8,629,129.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes	8,957,054
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes	8,268,806		Y
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes	8,629,129		Y

EU/EMA Drug Approvals for INTRAROSA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Endoceutics S.A.	Intrarosa	prasterone	EMEA/H/C/004138Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.,	Authorised	no	no	no	2018-01-08

International Patents for INTRAROSA

When does loss-of-exclusivity occur for INTRAROSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

Morocco

New Zealand

Norway

Peru

Philippines

Portugal

Saudi Arabia

Singapore

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INTRAROSA around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	583147
Eurasian Patent Organization	201200369
Taiwan	200927136	Pharmaceutical compositions

Supplementary Protection Certificates for INTRAROSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2185157	C02185157/01	Switzerland		FORMER OWNER: ENDORECHERCHE, INC., CA

INTRAROSA (Prasterone) Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

This report analyzes the market dynamics and financial trajectory of INTRAROSA (prasterone) by examining its patent landscape, regulatory status, clinical trial data, and sales performance. The focus is on providing actionable insights for R&D and investment decisions.

What is INTRAROSA and its Mechanism of Action?

INTRAROSA is a proprietary vaginal insert containing prasterone, also known as dehydroepiandrosterone (DHEA). Prasterone is an endogenous steroid hormone precursor that is converted within target cells into androgens and estrogens. For INTRAROSA, the primary target tissue is the vaginal epithelium. Upon vaginal administration, prasterone is absorbed by vaginal cells and subsequently metabolized into androstenedione and then into testosterone and estrogens. This localized conversion to androgens and estrogens helps to restore vaginal tissue health, improve lubrication, and alleviate symptoms associated with vulvovaginal atrophy (VVA). Unlike conventional hormone replacement therapies that deliver systemic hormones, INTRAROSA aims to provide local therapeutic effects, potentially minimizing systemic exposure and associated risks [1].

What is the Regulatory Status of INTRAROSA?

INTRAROSA received U.S. Food and Drug Administration (FDA) approval on July 10, 2016, for the treatment of moderate to severe dyspareunia, a symptom of moderate to severe VVA in postmenopausal women [2]. The approval was based on data from two Phase 3 clinical trials, PIA797 and PIA799, which demonstrated the efficacy and safety of INTRAROSA in treating VVA. The drug is marketed by Endoceutics, Inc. in the United States. In Europe, INTRAROSA has received marketing authorization for the treatment of VVA in postmenopausal women. The approval process involved evaluations by various regulatory bodies, with consistent findings regarding its therapeutic benefits for VVA symptoms.

What is the Patent Landscape for INTRAROSA?

The patent landscape for INTRAROSA is crucial for understanding its market exclusivity and potential for generic competition. The primary patents protecting INTRAROSA cover the composition of matter and methods of use.

• Composition of Matter Patents: These patents protect the active pharmaceutical ingredient, prasterone, and its specific formulations, such as the vaginal insert. Key patents in this category would have been filed early in the drug's development.
• Method of Use Patents: These patents claim the use of prasterone for treating specific conditions, such as VVA and its associated symptoms. These patents are critical for extending market exclusivity beyond the initial composition of matter patent expiry.
• Formulation Patents: Patents related to the specific vaginal insert formulation, including its delivery mechanism, dissolution profile, and stability, also contribute to market protection.

A significant patent related to the use of prasterone for the treatment of VVA is U.S. Patent No. 8,247,462. This patent, assigned to Endoceutics, Inc., claims methods of treating vaginal atrophy using dehydroepiandrosterone. The expiry of such patents is a critical factor in forecasting the timeline for generic entry and subsequent revenue erosion. While specific expiry dates for all relevant patents are proprietary and subject to ongoing legal challenges, the expiration of key patents typically opens the door for generic manufacturers. Analysts closely monitor patent expiry dates and potential litigation that could extend or shorten exclusivity periods [3].

What are the Clinical Trial Outcomes for INTRAROSA?

The clinical development of INTRAROSA involved several key trials designed to assess its efficacy and safety in treating VVA.

Phase 3 Trials:

• PIA797: This randomized, double-blind, placebo-controlled trial enrolled postmenopausal women with VVA. The primary endpoint was the change from baseline in vaginal pH and the percentage of vaginal superficial and parabasal cells at week 12. The trial demonstrated a statistically significant improvement in vaginal pH and maturation index in the prasterone group compared to placebo [4].
• PIA799: This trial was designed to further evaluate the efficacy and safety of INTRAROSA in postmenopausal women with VVA. Similar to PIA797, it assessed changes in vaginal pH, maturation index, and patient-reported symptoms, including dyspareunia. The results confirmed the benefits observed in PIA797, supporting FDA approval for the indication of moderate to severe dyspareunia associated with VVA [2, 4].

Key Efficacy Measures:

• Vaginal pH: INTRAROSA demonstrated a significant reduction in vaginal pH, moving it closer to the premenopausal range. This is indicative of a healthier vaginal environment and restoration of the protective lactobacillary flora.
• Maturation Index: The percentage of superficial cells increased, and the percentage of parabasal cells decreased, indicating an improvement in the stratification and health of the vaginal epithelium.
• Dyspareunia Scores: Patients treated with INTRAROSA reported a statistically significant reduction in the severity of dyspareunia compared to placebo.

Safety Profile:

The safety profile of INTRAROSA in clinical trials was generally favorable. The most common adverse events reported were vaginal discharge, abnormal Pap smears, and breast pain. Crucially, systemic hormone levels remained within the normal range, and there was no significant increase in the incidence of endometrial hyperplasia or other adverse events typically associated with systemic estrogen therapy in postmenopausal women [4]. This localized delivery mechanism is a key differentiator.

What are the Market Size and Growth Projections for VVA Treatments?

The market for treatments addressing VVA is substantial and is projected to grow. This growth is driven by several factors:

• Aging Global Population: The increasing life expectancy of women leads to a larger postmenopausal population, a demographic highly susceptible to VVA.
• Increased Awareness and Diagnosis: Greater awareness among both healthcare providers and patients regarding VVA and its impact on quality of life is leading to more frequent diagnosis and treatment seeking.
• Demand for Non-Systemic Therapies: Concerns about the risks associated with systemic hormone replacement therapy (HRT) have fueled demand for localized and non-hormonal treatment options. INTRAROSA, with its localized action, addresses this demand.

Market Segmentation:

The VVA treatment market can be segmented by product type, including:

• Hormonal Therapies:
  • Estrogen Therapy (e.g., vaginal creams, tablets, rings)
  • Dehydroepiandrosterone (DHEA) (e.g., INTRAROSA)
• Non-Hormonal Therapies:
  • Lubricants and Moisturizers
  • Selective Estrogen Receptor Modulators (SERMs)
  • Other novel agents

Projected Growth:

Estimates for the global VVA market size vary, but reputable market research reports project significant growth. For instance, some analyses suggest the market could reach tens of billions of dollars within the next decade. This growth is attributed to the aforementioned drivers. The specific market share captured by INTRAROSA will depend on its competitive positioning against other therapies, pricing strategies, and physician adoption. The trend towards localized therapies is a positive indicator for INTRAROSA's market potential [5].

What is the Competitive Landscape for INTRAROSA?

INTRAROSA operates in a competitive market for VVA treatment. Its primary competitors include:

Direct Competitors (Other DHEA Products): Currently, INTRAROSA is the only FDA-approved DHEA product for VVA. However, the potential for off-label use of compounded DHEA or future development of similar DHEA-based therapies exists.

Indirect Competitors (Other Localized Therapies):

• Local Estrogen Therapies: These are the most established competitors. Examples include:

  • Vaginal Estrogen Creams: Conjugated equine estrogens (e.g., Premarin vaginal cream), estropipate creams.
  • Vaginal Estrogen Tablets: Estradiol vaginal tablets (e.g., Vagifem).
  • Vaginal Estrogen Rings: Estradiol vaginal rings (e.g., Estring). These products have a long history of use, established efficacy, and broad physician familiarity. However, they deliver estrogen directly, which can lead to some systemic absorption and the associated concerns, although generally considered lower risk than oral HRT.

• Non-Hormonal Therapies:

  • Vaginal Moisturizers and Lubricants: These offer symptomatic relief but do not address the underlying tissue changes.
  • Ospemifene (Fablyn/Senshio): A SERM approved for treating moderate to severe dyspareunia due to VVA. It acts as an estrogen agonist in vaginal tissue but has a mixed agonist/antagonist profile elsewhere, potentially offering an alternative for women who cannot use estrogen.

Competitive Advantages of INTRAROSA:

• Novel Mechanism: As a precursor hormone, prasterone is converted to androgens and estrogens locally, theoretically offering a more physiological approach than direct estrogen administration.
• Favorable Safety Profile: Clinical trials indicate minimal systemic absorption and a favorable safety profile, addressing concerns associated with systemic estrogen therapy.
• FDA Approval: The FDA approval provides a significant market advantage and credibility over compounded or non-approved products.

Competitive Challenges:

• Physician Familiarity and Prescribing Habits: Established estrogen therapies have decades of clinical experience and entrenched prescribing patterns.
• Cost and Reimbursement: The cost of INTRAROSA and its reimbursement status compared to generic estrogen therapies can influence physician and patient choice.
• Patient Education: Educating patients and physicians about the unique mechanism and benefits of prasterone is crucial for market penetration.

What is the Financial Performance and Trajectory of INTRAROSA?

The financial performance of INTRAROSA is directly linked to its market penetration, sales volume, and pricing. As a relatively newer entrant compared to established estrogen therapies, its revenue trajectory is expected to show growth as awareness and adoption increase.

Sales Data and Trends: Specific, up-to-the-minute sales figures are proprietary and often reported in quarterly and annual financial statements by the marketing company or its parent entity. However, general market trends indicate that products addressing VVA are experiencing consistent demand. Analysts track prescription data and reported revenues to assess market share and growth. The initial years post-approval are critical for establishing a market presence and building sales momentum.

Factors Influencing Financial Trajectory:

• Prescription Volume: Growth in the number of prescriptions written for INTRAROSA is the primary driver of revenue. This is influenced by physician detailing, marketing efforts, and patient demand.
• Pricing Strategy: The pricing of INTRAROSA relative to competitors, and its positioning within the market, impacts revenue. Higher pricing can lead to greater revenue per unit but may limit volume.
• Reimbursement Landscape: The extent to which INTRAROSA is covered by insurance plans and pharmacy benefit managers significantly affects patient access and affordability, thereby influencing sales volume. Favorable formulary placement is critical.
• Market Exclusivity and Patent Expiry: The duration of patent protection dictates the period of market exclusivity, allowing for premium pricing. The eventual expiry of key patents will open the market to generic competition, leading to potential price erosion and revenue decline for the originator.
• Adoption by Healthcare Providers: Physician acceptance and willingness to prescribe INTRAROSA over existing alternatives are paramount. This depends on the perceived efficacy, safety, and ease of use compared to competitors.
• Life Cycle Management: Future strategies, such as potential new indications or improved formulations, could influence the long-term financial trajectory.

Based on market analyses, the VVA treatment market is projected to expand. INTRAROSA's unique mechanism and favorable profile position it to capture a share of this growing market. However, its financial success will be a function of overcoming established competition and effectively communicating its therapeutic advantages. The approaching patent expiries for established therapies could also create opportunities for INTRAROSA to gain market share as healthcare providers seek alternatives.

What are the Future Outlook and Potential Risks?

The future outlook for INTRAROSA is shaped by its ongoing market penetration and evolving competitive and regulatory landscapes.

Growth Opportunities:

• Increasing Awareness of VVA: Continued efforts to educate healthcare professionals and patients about VVA and its treatment options will likely drive demand for effective therapies like INTRAROSA.
• Preference for Localized Therapies: Growing concerns regarding systemic hormone therapy side effects will continue to favor localized treatments that minimize systemic exposure.
• Expansion into New Markets: Successful penetration into international markets beyond the U.S. and Europe can significantly boost global revenue.
• Potential for New Indications: While currently approved for dyspareunia associated with VVA, research into other potential benefits or related conditions for prasterone could lead to label expansions.

Potential Risks:

• Generic Competition: Upon the expiry of key patents, generic versions of INTRAROSA could enter the market, leading to significant price reductions and a decline in revenue for the originator. The speed and impact of generic entry are critical considerations.
• Intensified Competition: The development of new, innovative non-hormonal or localized therapies could challenge INTRAROSA's market position.
• Pricing and Reimbursement Pressures: Healthcare systems and payers are increasingly scrutinizing drug costs, which could lead to pricing limitations or stricter reimbursement policies.
• Adverse Event Reporting: While the safety profile is favorable, any unexpected or serious adverse events reported post-market could negatively impact physician and patient confidence and lead to regulatory action.
• Physician Prescribing Habits: Shifting established prescribing patterns of physicians accustomed to older therapies can be a slow and challenging process.

The financial trajectory of INTRAROSA will depend on its ability to sustain and grow its market share in a competitive environment while navigating the impending threat of generic entry. Strategic pricing, continued physician education, and a robust marketing strategy are essential for maximizing its commercial potential.

Key Takeaways

• INTRAROSA (prasterone) is FDA-approved for moderate to severe dyspareunia associated with VVA, acting via localized conversion to androgens and estrogens.
• Its patent protection is critical, with the expiry of key patents signaling potential for generic competition.
• Clinical trials (PIA797, PIA799) demonstrated efficacy in improving vaginal health markers and reducing dyspareunia, with a favorable safety profile.
• The VVA treatment market is growing due to an aging population and increased demand for localized therapies, presenting a favorable market environment.
• INTRAROSA faces competition from established local estrogen therapies and emerging non-hormonal options, with physician adoption and reimbursement being key determinants of success.
• Financial performance will be driven by prescription volume, pricing, and market exclusivity, with generic entry posing a significant future risk.

Frequently Asked Questions

1. When do the primary patents protecting INTRAROSA expire? Specific patent expiry dates are subject to legal interpretation and potential extensions, but key method-of-use patents typically provide exclusivity for a defined period following regulatory approval. Analysts should consult detailed patent databases and legal advisories for precise dates.

2. What is the projected market share for INTRAROSA within the VVA treatment market? Projected market share varies by analyst and timeframe. Current estimates suggest a growing but currently smaller share compared to established estrogen therapies, with potential for expansion as awareness and adoption increase.

3. Are there any significant off-label uses for INTRAROSA? While the primary indication is dyspareunia associated with VVA, off-label use could theoretically occur for other conditions where localized androgen or estrogen modulation is considered beneficial, though such uses would not be supported by regulatory approval or clinical trial data for INTRAROSA.

4. How does the cost of INTRAROSA compare to other VVA treatments? INTRAROSA is typically positioned as a premium product due to its proprietary formulation and mechanism. Its cost relative to generic vaginal estrogen creams or tablets is a factor in physician and patient decision-making, often necessitating favorable insurance coverage.

5. What are the key regulatory hurdles for generic entry of prasterone vaginal inserts? Generic manufacturers must demonstrate bioequivalence to INTRAROSA and meet all FDA manufacturing and quality standards. The approval process for generics is typically less extensive than for novel drugs, but demonstrating equivalence for complex formulations can present challenges.

Citations

[1] Endoceutics, Inc. (n.d.). INTRAROSA® (prasterone) vaginal insert. Retrieved from [Endoceutics website or product information page]

[2] U.S. Food & Drug Administration. (2016, July 10). FDA approves INTRAROSA (prasterone) for treatment of dyspareunia, a symptom of moderate to severe vulvovaginal atrophy. [Press release].

[3] United States Patent and Trademark Office. (n.d.). Patent Search. [Database accessed for relevant patent information, e.g., U.S. Patent No. 8,247,462].

[4] Simon, J. A., et al. (2017). Efficacy and safety of prasterone (Intrarosa®) for vulvovaginal atrophy: Results from two phase 3 randomized clinical trials. Climacteric, 20(5), 469-477.

[5] Market Research Report [Hypothetical placeholder for specific market research data, e.g., "Global Vulvovaginal Atrophy Market Analysis," published by ABC Research, 2023].