PRASTERONE - Generic Drug Details

What are the generic sources for prasterone and what is the scope of patent protection?

Prasterone is the generic ingredient in one branded drug marketed by Millicent and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Prasterone has fifty-eight patent family members in thirty-one countries.

There are seven drug master file entries for prasterone. One supplier is listed for this compound.

Summary for PRASTERONE

International Patents:	58
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	17
Patent Applications:	6,792
What excipients (inactive ingredients) are in PRASTERONE?	PRASTERONE excipients list
DailyMed Link:	PRASTERONE at DailyMed

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

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 PRASTERONE

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 PRASTERONE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for PRASTERONE

A14AA	Androstan derivatives
A14A	ANABOLIC STEROIDS
A14	ANABOLIC AGENTS FOR SYSTEMIC USE
A	Alimentary tract and metabolism

G03XX	Other sex hormones and modulators of the genital system
G03X	OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for PRASTERONE

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
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes			Y
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes			Y

EU/EMA Drug Approvals for PRASTERONE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Endoceutics S.A.	Intrarosa	prasterone	EMEA/H/C/004138 Intrarosa 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 PRASTERONE

Country	Patent Number	Title	Estimated Expiration
China	109893526	治疗绝经期的DEHA组合物 (DHEA compositions for treating menopause)
South Africa	201000874	Dhea compositions for treating menopause
China	105412121	DHEA compositions for treating menopause
Australia	2008286651	DHEA compositions for treating menopause

Supplementary Protection Certificates for PRASTERONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2185157	C02185157/01	Switzerland		PRODUCT NAME: PRASTERON; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67323 19.05.2020

PRASTERONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prasterone

Introduction

Prasterone, a synthetic form of dehydroepiandrosterone (DHEA), is used to treat symptoms of vulvar and vaginal atrophy (VVA) in postmenopausal women. Understanding the market dynamics and financial trajectory of prasterone is crucial for pharmaceutical companies, investors, and healthcare providers.

Clinical Efficacy and Safety

Prasterone has shown clinical benefits in treating VVA symptoms, particularly dyspareunia, vaginal dryness, and changes in vaginal cell composition and pH. Studies such as the ERC-238, ERC-231, and ERC-230 trials have demonstrated its efficacy compared to placebo, although its long-term safety and efficacy compared to other vaginal estrogen therapies remain under scrutiny[4][5].

Market Positioning

Comparative Analysis

Prasterone is often compared to other local hormone therapies, including estradiol vaginal tablets (Vagifem), estrone cream (Estragyn), the estradiol ring (Estring), and conjugated estrogens (CE) cream (Premarin). Economic evaluations suggest that prasterone is more costly than most of these alternatives, with limited evidence to support a price premium. For instance, a price reduction of 89% would be necessary for prasterone to be cost-neutral compared to CE cream[1].

Patient and Prescriber Adoption

Despite its higher cost, prasterone may still attract patients and prescribers due to its unique profile, particularly for those with contraindications to vaginal estrogen therapies. However, achieving significant market share depends on factors such as insurance coverage, patient affordability programs, and prescriber education[2][4].

Financial Trajectory

Pricing and Revenue

The annual cost of prasterone therapy is approximately $532 per patient, based on a daily dose of 6.5 mg at $1.46 per ovule. This pricing makes it less competitive compared to other treatments unless significant discounts or coverage improvements are implemented[1].

Insurance Coverage and Reimbursement

Commercial insurance coverage plays a critical role in the financial trajectory of prasterone. Companies like TherapeuticsMD, which markets prasterone under the brand name Intrarosa, have worked to achieve high levels of commercial insurance coverage. By 4Q 2019, they expected to have full commercial insurance coverage established, which would significantly impact net revenue. For example, with 60% net revenue of the Wholesale Acquisition Cost (WAC), the average net revenue per script could be around $162 for a blended starter and maintenance package[2].

Net Revenue and Growth Projections

The net revenue for prasterone is influenced by the product mix of starter and maintenance packages. With a projected product mix of two starter packs to every three maintenance packs, the blended WAC and net revenue can be optimized. Each incremental fill per year can add an estimated $75 million to the net revenues, assuming no market growth and no price increases[2].

Cost-Utility Analysis

Incremental Cost-Effectiveness Ratio (ICER)

The cost-utility analysis indicates that prasterone is associated with an ICER of $9,861 per Quality-Adjusted Life Year (QALY) gained compared to no treatment. However, when compared to other treatments like CE cream, prasterone is often dominated due to its higher cost and similar or slightly lower efficacy[1].

Sensitivity and Scenario Analysis

Scenario analyses have been conducted to compare prasterone with other available comparators. These analyses suggest that CE cream is the least expensive and most effective option, making prasterone less favorable unless its price is significantly reduced. The sensitivity of these analyses to different assumptions, such as treatment discontinuation rates and long-term efficacy, highlights the need for robust long-term data to support prasterone's market position[1].

Patient Affordability and Compliance

Patient affordability programs are crucial for increasing compliance and adherence to prasterone therapy. Most patients pay an out-of-pocket copay between $15 to $35, which can be managed through affordability and education programs. These programs aim to increase patient engagement and drive incremental fills, thereby enhancing net revenues[2].

Market Size and Budget Impact

The market size for VVA treatments could increase if prasterone becomes a preferred option for patients with contraindications to vaginal estrogen therapies. However, the budget impact would depend on the pricing strategy and the extent of insurance coverage. A significant reduction in price or improved coverage could make prasterone more competitive and increase its market share[4].

Key Takeaways

• Clinical Efficacy: Prasterone is effective in treating VVA symptoms but lacks long-term safety and efficacy data compared to other treatments.
• Market Positioning: Prasterone is more costly than most other local hormone therapies, requiring significant price reductions to be cost-competitive.
• Financial Trajectory: Insurance coverage and patient affordability programs are critical for optimizing net revenue.
• Cost-Utility Analysis: Prasterone has a high ICER compared to no treatment but is often dominated by CE cream in cost-effectiveness analyses.
• Market Size and Budget Impact: The market size could increase if prasterone is preferred for patients with contraindications to estrogen therapies, but this depends on pricing and coverage.

FAQs

What is prasterone, and how is it used?

Prasterone is a synthetic form of dehydroepiandrosterone (DHEA) used to treat symptoms of vulvar and vaginal atrophy (VVA) in postmenopausal women.

How does prasterone compare to other VVA treatments in terms of cost?

Prasterone is more costly than most other local hormone therapies, such as CE cream and estradiol vaginal tablets, and would require a significant price reduction to be cost-competitive[1].

What is the impact of insurance coverage on the financial trajectory of prasterone?

Full commercial insurance coverage is crucial for optimizing net revenue for prasterone. Companies aim to achieve high levels of coverage to increase patient access and reduce out-of-pocket costs[2].

How does prasterone affect patient compliance and adherence?

Patient affordability programs and education initiatives are essential for increasing compliance and adherence to prasterone therapy, helping to drive incremental fills and enhance net revenues[2].

What are the long-term safety and efficacy concerns associated with prasterone?

There is limited evidence on the long-term safety and efficacy of prasterone, particularly concerning rare events like malignant neoplasms. Longer follow-up studies are needed to better understand its long-term safety profile[4].

Sources

1. Pharmacoeconomic Review - Prasterone (Intrarosa) - NCBI Bookshelf
2. Oppenheimer NDR_TXMD Final 3 - TherapeuticsMD Inc
3. Vision, legacy and quality are shaping our growth.
4. Prasterone (Intrarosa) - NCBI Bookshelf
5. Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone)