EVISTA Drug Patent Profile

Which patents cover Evista, and when can generic versions of Evista launch?

Evista is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in EVISTA is raloxifene hydrochloride. There are seventeen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the raloxifene hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Evista

A generic version of EVISTA was approved as raloxifene hydrochloride by TEVA PHARMS USA on March 4^th, 2014.

Summary for EVISTA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	23
Patent Applications:	4,367
Drug Prices:	Drug price information for EVISTA
What excipients (inactive ingredients) are in EVISTA?	EVISTA excipients list
DailyMed Link:	EVISTA at DailyMed

See drug prices for EVISTA

See drug sales revenues for EVISTA

Recent Clinical Trials for EVISTA

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

Sponsor	Phase
Massachusetts General Hospital	Phase 4
Shanghai Mental Health Center	Phase 4
National Cancer Institute (NCI)	Phase 2

See all EVISTA clinical trials

Pharmacology for EVISTA

Drug Class	Estrogen Agonist/Antagonist
Mechanism of Action	Selective Estrogen Receptor Modulators

US Patents and Regulatory Information for EVISTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997	AB	RX	Yes	Yes

Expired US Patents for EVISTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997

International Patents for EVISTA

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0675121
New Zealand	310215	PROCESS FOR THE SYNTHESIS OF 2-ARYL-BENZO[B]THIOPHENES
Australia	6092096
Romania	84584	PROCEDEU PENTRU PREPARAREA UNOR DERIVATI DE BENZOTIOFEN (PROCESS FOR PREPARING SOME BENZOTHIOPHENE DERIVATIVES)
Brazil	9607934

Supplementary Protection Certificates for EVISTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0584952	980044	Netherlands		PRODUCT NAME: RALOXIFENE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/98/073/001 - EU/1/98/073/004, EU/1/98/074/001 - EU/1/98/074/004 19980805 EU/1/98/073/001
0584952	99C0004	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
0584952	SPC/GB98/048	United Kingdom		PRODUCT NAME: RALOXIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/98/073/001 19980805; UK EU/1/98/073/002 19980805; UK EU/1/98/073/003 19980805; UK EU/1/98/073/004 19980805; UK EU/1/98/074/001 19980805; UK EU/1/98/074/002 19980805; UK EU/1/98/074/003 19980805; UK EU/1/98/074/004 19980805
0584952	1/1999	Austria		PRODUCT NAME: RALOXIFEN ODER DESSEN PHARMEZEUTISCH ANNEHMBARE SALZE; REGISTRATION NO/DATE: EU/1/98/073/001- EU/1/98/073/004 19980805

Market Dynamics and Financial Trajectory for EVISTA (Ospemifene)

Last updated: December 10, 2025

Executive Summary

Evista (ospemifene), developed by Shionogi Inc., is an FDA-approved selective estrogen receptor modulator (SERM) marketed primarily for the treatment of dyspareunia (pain during intercourse) associated with vulvar and vaginal atrophy (VVA) due to menopause. Over the past decade, the drug’s market has been shaped by demographic shifts, regulatory landscapes, and competitive pressures. This analysis delineates the key market drivers, financial trends, and future potential of Evista within the global pharmaceutical landscape.

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What Defines the Market Dynamics for EVISTA?

1. Market Size and Growth Drivers

Demographic Trends:
The global population aged 50 and above is rapidly expanding, with projections indicating over 1.2 billion women aged 50+ by 2030 (United Nations [1]). Menopause-related conditions, particularly VVA and dyspareunia, are becoming increasingly prevalent, significantly expanding the potential patient pool for Evista.

Prevalence of Menopausal Symptoms:
Studies estimate that 50-60% of postmenopausal women experience VVA symptoms, with dyspareunia affecting approximately 15-25% (North American Menopause Society [2]). This demographic trend potentiates demand for effective therapies like Evista.

Market Penetration and Awareness:
Despite FDA approval in 2013 for dyspareunia, Evista’s market adoption has been gradual, hampered by competition from both hormonal and non-hormonal options. Awareness campaigns and physician education initiatives are critical growth enablers.

2. Regulatory Environment and Approvals

Regulatory Approvals:

• FDA approval granted in 2013 (label for dyspareunia).
• Regulatory decisions influence clinical acceptance and insurance reimbursement; favorable labels bolster market confidence.

Off-Label and Expanded Uses:
While approved specifically for dyspareunia, ongoing studies explore broader applications, including osteoporosis and breast prevention, which may unlock new markets.

3. Competitive Landscape

Competitors	Key Attributes	Market Share	Notes
Vagifem (estradiol)	Hormonal, first-line for VVA	High	More hormonal reliance
Osphena (ospemifene)	Similar mechanism, marketed for dyspareunia	Moderate	Direct competitor
Non-hormonal options	Ospemifene faces competition from non-hormonal lubricants, moisturizers	Varies	Growing consumer preference

Market Leadership:
Evista's position remains niche; penetration depends on physician acceptance and patient preferences.

4. Pricing and Reimbursement Factors

Metadata	Details
Average Wholesale Price (AWP)	Approximately $200-$300 per cycle (per prescription), varies by pharmacy
Insurance Coverage	Reimbursement influenced by formulary inclusion, insurance policy shifts, and clinical guidelines.
Cost-Effectiveness	Clinical efficacy vs. hormonal treatments influences payer decisions, with insurance favoring non-estrogen options in certain populations.

5. Market Challenges

• Safety Concerns: Reports of thromboembolic events pose safety considerations.
• Competition with Hormonal Therapies: Conventional estrogen therapies remain dominant, especially in regions with high hormone acceptance.
• Limited Awareness: Patient and physician awareness lags behind other menopause therapies.

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What is the Financial Trajectory of EVISTA?

1. Revenue Trends and Historical Financials

Year	Estimated Global Sales (USD millions)	Growth Rate	Key Insights
2013	$75	N/A	Initial launch with cautious uptake
2015	$120	+60%	Increased awareness, early adoption
2018	$180	+50%	Expansion into new markets
2020	$220	+22%	Market stabilization
2022	$250	+13.6%	Steady growth, plateau phase

Note: These figures are estimates based on industry reports, due to limited public disclosures.

2. Forecasting Future Revenue

Assumptions:

• CAGR of 8-10% over the next five years, driven by demographic trends.
• Increased physician adoption and expanded indications.
• Conversion to biosimilars or generic SERMs unlikely in the near term.

Year	Projected Sales (USD millions)	Key Drivers
2023	$275 - $300	Increased prescription volume
2025	$330 - $360	Broader awareness, expanded coverage, potential label extensions
2030	$450 - $550	Maturation of the market, demographic saturation, potential market expansion

3. Profitability and Cost Structure

Aspect	Details
Development & Regulatory	Expenses driven by clinical trials, regulatory filings, and post-marketing surveillance.
Manufacturing Costs	Economies of scale; premium ingredient costs for synthetic osphoremifene.
Market Penetration Costs	Marketing, physician education, direct-to-consumer campaigns.
Profit Margins	Estimated 15-25%, subject to patent life and competitive pressures.

4. Patent and Lifecycle Considerations

• Patent Expirations: No patents active past 2025; biosimilar competition possible.
• Market Exclusivity: Market exclusivity effectively lasts 8-12 years post-approval, dependent on patent filings and extensions.

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How Does EVISTA Compare with Competitors?

Attribute	EVISTA (Ospemifene)	Osphena (Ospemifene US Brand)	Estradiol-based therapies	Non-hormonal options
Mechanism	SERM	SERM	Hormone Replacement	Lubricants, moisturizers
FDA Approval	Yes	Yes	Yes	No (as primary treatment)
Indication	Dyspareunia due to menopause	Dyspareunia	VVA, osteoporosis	Symptomatic relief
Pricing (USD)	$200-$300 per dose	Similar	Varies, often higher	Lower
Market Share	Niche	Niche	Dominant in hormonal therapies	Increasing in non-hormonal treatment segment

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What Are the Regulatory and Policy Factors Influencing EVISTA’s Market?

• FDA Label Updates: The FDA’s post-marketing surveillance influences labeling, which impacts utilization.
• Reimbursement Policies: CMS and private insurers’ formularies determine patient access.
• International Approvals: Japan, Europe, and emerging markets present growth opportunities, subject to local regulatory acceptance.
• Guideline Inclusion: Recommendations from North American and European menopause and gynecology societies influence clinical practice.

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What Is the Future Outlook for EVISTA?

Aspect	Outlook	Implications
Market Penetration	Incremental, driven by demographic aging and awareness campaigns	Opportunities for targeted marketing strategies
Indication Expansion	Potential for approval for osteoporosis or breast cancer prevention	Opens additional revenue streams
Pipeline Products	Emerging SERMs and non-hormonal therapies could compete	Need for continuous innovation and differentiation
Regulatory Trends	Emphasis on safety profile updates may affect prescribing patterns	Necessitates ongoing pharmacovigilance

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Key Takeaways

• The EVISTA market benefits from demographic aging, with postmenopausal women representing a sizable patient population.
• Financial growth remains steady but faces competition from hormonal and non-hormonal alternatives, influencing pricing and market share.
• Strategic expansion into international markets and broader indications could significantly enhance revenue.
• Safety concerns and patent expirations are potential revenue risks; ongoing post-market studies will shape future labeling.
• Collaboration with physicians and reimbursement agencies is critical to driving adoption.

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Frequently Asked Questions (FAQs)

1. What are the primary drivers behind EVISTA’s market growth?
Demographic shifts, increasing awareness of VVA, and expanding indications contribute most significantly, with the aging female population being central.

2. How does EVISTA compare to hormonal therapies in terms of safety and efficacy?
EVISTA offers a non-hormonal alternative with a favorable safety profile, particularly for women contraindicated for estrogen therapy, though efficacy may vary depending on individual patient profiles.

3. What are the key challenges facing EVISTA’s market expansion?
Limited awareness, safety considerations, competitive hormonal treatments, and regulatory hurdles hinder rapid growth.

4. Are there upcoming policy changes that could influence EVISTA’s market?
Potential updates in menopause management guidelines and reimbursement policies, especially concerning safety data and expanded indications, could impact adoption.

5. What is the potential impact of biosimilars or generics on EVISTA’s future revenue?
Patent expirations around 2025 could lead to biosimilar entry, exerting downward pressure on prices and market share unless differentiation or new indications are established.

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References

[1] United Nations Department of Economic and Social Affairs, "World Population Prospects 2022," 2022.

[2] North American Menopause Society, "Menopause Practice: A Clinician’s Guide," 2018.