DUAVEE Drug Patent Profile

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

Duavee is a drug marketed by Wyeth Pharms and is included in one NDA. There is one patent protecting this drug.

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

The generic ingredient in DUAVEE is bazedoxifene acetate; estrogens, conjugated. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bazedoxifene acetate; estrogens, conjugated profile page.

DrugPatentWatch^® Generic Entry Outlook for Duavee

Duavee was eligible for patent challenges on October 13, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 10, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DUAVEE

International Patents:	22
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	12
Patent Applications:	13
Drug Prices:	Drug price information for DUAVEE
What excipients (inactive ingredients) are in DUAVEE?	DUAVEE excipients list
DailyMed Link:	DUAVEE at DailyMed

See drug prices for DUAVEE

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

Constraining patent/regulatory exclusivity:

7,683,051

NDA:

022247

Dosage:

TABLET;ORAL

^*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 DUAVEE

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

Sponsor	Phase
VA Office of Research and Development	Phase 2
Penn State University	Phase 4
The John B. Pierce Laboratory	Phase 4

See all DUAVEE clinical trials

Pharmacology for DUAVEE

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

US Patents and Regulatory Information for DUAVEE

DUAVEE is protected by two US patents.

This potential generic entry date is based on patent 7,683,051.

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
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013		RX	Yes	Yes	7,683,051		Y	Y

Expired US Patents for DUAVEE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013	5,998,402
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013	8,815,934
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013	6,479,535
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013	7,138,392

International Patents for DUAVEE

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

Country	Patent Number	Title	Estimated Expiration
Norway	309564
Colombia	4900051	AGENTES ESTROGENICOS
Japan	4093611
Portugal	802183
Austria	206701
Slovakia	47297	ESTROGENIC AGENTS, PHARMAUCEUTICAL COMPOSITION CONTAINING THEM AND THEIR USE

Supplementary Protection Certificates for DUAVEE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0802183	09C0048	France		PRODUCT NAME: BAZEDOXIFENE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/09/511/001 DU 20090417; REGISTRATION NO/DATE AT EEC: EU/1/09/511/001-004 DU 20090417
0802183	CA 2009 00035	Denmark
0802183	91608	Luxembourg		91608, EXPIRES: 20220415
0802183	PA2009007	Lithuania		PRODUCT NAME: BAZEDOXIFENUM; REGISTRATION NO/DATE: EU/1/09/511/001 - EU/1/09/511/004 20090417
0802183	364	Finland
0802183	2009/028	Ireland		PRODUCT NAME: BAZEDOXIFENE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/09/511/001-004 20090417

Market Dynamics and Financial Trajectory for DUAVEE

Last updated: July 27, 2025

Introduction

DUAVEE is a combined hormonal therapy indicated primarily for menopausal women experiencing vasomotor symptoms such as hot flashes and night sweats. Developed by Duchesnay, a pharmaceutical company specializing in hormonal treatments, DUAVEE combines conjugated estrogens and bazedoxifene, an estrogen agonist/antagonist, designed to offer symptomatic relief while attenuating risks associated with hormone therapy. Understanding DUAVEE’s market dynamics and financial trajectory hinges on multiple factors—including demographic trends, regulatory landscape, competition, clinical positioning, and healthcare policies.

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Market Landscape and Demographic Drivers

Growing menopausal demographic

The global population of women aged 50 and above is expanding rapidly, reflecting increased life expectancy and aging populations. According to the World Health Organization, the number of women in this age bracket is projected to reach 1.2 billion by 2030, fueling demand for menopause-related therapies (WHO, 2021). In North America and Europe, this demographic represents a substantial market segment for hormone replacement therapies (HRT).

Shift toward improved safety profiles

Traditional estrogen therapy faced declining acceptance following studies linking long-term use to breast cancer and cardiovascular risks (e.g., the Women's Health Initiative). Consequently, there is a shifting preference toward therapies that optimize efficacy while minimizing adverse effects. DUAVEE’s unique formulation as a SERM (selective estrogen receptor modulator) aims to provide a safer alternative to classical hormone therapies, fostering greater acceptance among physicians and patients.

Clinical positioning: targeted therapy for menopausal symptoms

DUAVEE fits into the broader estrogenic therapies landscape but distinguishes itself by combining estrogen with bazedoxifene to mitigate risks of endometrial hyperplasia and breast cancer, common concerns diminishing the appeal of traditional HRTs. Its positioning as a tailored therapy for women seeking symptom relief with a favorable safety profile supports its market penetration strategies.

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Regulatory and Patent Landscape

Regulatory approvals

Since its initial approval by the FDA in 2013, DUAVEE has maintained a steady regulatory standing. Post-approval, the therapy primarily fulfills unmet needs among women seeking HRT options with a lower risk of adverse effects, especially in the U.S. and European markets where regulatory bodies have been increasingly cautious about hormone therapy safety.

Patent protection and lifecycle

DUAVEE benefits from core patents related to its formulation and delivery mechanisms until approximately 2030. Patent expirations could open competitive avenues, including generic formulations, potentially impacting pricing and market share. To extend its commercial lifespan, Duchesnay could pursue new indications or formulation improvements.

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Competitive Environment

Key competitors

• Traditional HRTs: Premarin, Estrace, and other estrogen-progestin formulations dominate the initial menopause market segment.
• SERMs and other selective therapies: Companies like Eli Lilly (with raloxifene) and GSK (with ospemifene) offer alternatives targeting osteoporosis and vulvar/vaginal atrophy.
• Emerging therapies: Novel compounds and biosimilars aiming to improve safety, efficacy, and administration routes continually challenge DUAVEE’s market position.

Market penetration and adoption

Physician prescribing practices are influenced heavily by safety data, clinical guidelines, and patient preferences. DUAVEE’s adoption accelerates as clinicians seek treatments with proven safety profiles, especially for women at increased breast cancer risk who require symptom management without exacerbating their risk profile.

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Pricing and Reimbursement Dynamics

Pricing strategies

As a branded therapy with patent protection, DUAVEE commands premium pricing relative to generic hormone therapies. In an environment increasingly emphasizing cost-effectiveness, limited insurance coverage or high out-of-pocket costs could restrain patient access, especially in non-U.S. markets.

Reimbursement scenarios

Coverage largely depends on regional healthcare systems. In the U.S., reimbursement by Medicare and private insurers hinges on clinical guideline endorsement and cost-benefit analyses. Evidence demonstrating reduced adverse events compared to traditional HRTs could enhance reimbursement prospects, thereby increasing utilization.

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Financial Trajectory and Future Outlook

Revenue projections

DUAVEE’s sales trajectory is expected to follow the demographic growth of the menopausal population and evolving physician acceptance. Duchesnay anticipates a gradual uptick in market penetration as clinical data further substantiates safety claims and as awareness campaigns reach healthcare providers.

Potential growth catalysts

• Expansion into new markets: Asia-Pacific and Latin America present untapped potential, where aging populations and increasing healthcare infrastructure facilitate larger adoption.
• Broadening indications: Research exploring DUAVEE’s utility in osteoporosis or other estrogen-dependent conditions could diversify revenue streams.
• Innovation and pipeline developments: Developing alternate formulations such as transdermal patches or oral disintegrating tablets could improve patient adherence and market share.

Risks impacting financial performance

Regulatory setbacks, patent expirations, competition from biosimilars or new entrants, and shifts in clinical guidelines restrict growth potential. Additionally, economic downturns affecting healthcare budgets and patient affordability could dampen sales.

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Conclusion

DUAVEE’s market dynamics are anchored in demographic shifts toward an aging female population seeking safer hormone therapy options, complemented by a favorable regulatory environment and evolving clinical paradigms. Its financial trajectory indicates potential steady growth, contingent upon successful market expansion, competitive positioning, and sustained perception of safety and efficacy. Strategic focus on geographical diversification, indication expansion, and innovation will be pivotal in optimizing its market performance over the next decade.

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Key Takeaways

• The expanding menopausal demographic globally ensures a growing demand for therapies like DUAVEE, especially as safety considerations become paramount.
• DUAVEE’s unique formulation as a combination of estrogen and bazedoxifene positions it favorably against traditional HRTs, favoring clinician and patient adoption.
• Regulatory and patent landscapes are critical; patent protections until 2030 provide a window for revenue maximization before potential biosimilar competition.
• Market penetration depends heavily on reimbursement strategies and clinical guideline endorsement; demonstrating safety advantages is crucial.
• Future growth hinges on geographic expansion, indication diversification, and innovation in delivery methods to maintain competitive advantage.

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FAQs

1. What distinguishes DUAVEE from traditional hormone replacement therapies?

DUAVEE combines conjugated estrogens with bazedoxifene, a selective estrogen receptor modulator, providing menopausal symptom relief with a lower risk profile for breast and endometrial cancers compared to traditional estrogen-progestin therapies.

2. How does demographic change influence DUAVEE’s market potential?

The increasing number of women aged 50+ worldwide drives demand for menopause therapies. As this demographic expands, so does the potential market for DAGUEE, especially with growing emphasis on safety profiles.

3. What are the primary competitors of DUAVEE?

Traditional estrogen therapies, other SERMs such as raloxifene, and emerging biosimilars pose competitive challenges. Market differentiation depends on safety profile, efficacy, and patient adherence options.

4. What are the key risks affecting DUAVEE’s financial outlook?

Patent expirations, regulatory changes, market entry of biosimilars, and shifts in clinical guidelines could reduce revenues. Additionally, reimbursement limitations and high pricing could constrain access.

5. What strategies can enhance DUAVEE’s market penetration?

Expanding into emerging markets, securing insurance reimbursement, conducting further clinical studies for new indications, and developing alternative formulations are strategic avenues to reinforce growth.

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References

1. World Health Organization. (2021). Ageing and health.
2. Women's Health Initiative. (2002). Risks and benefits of estrogen plus progestin in healthy postmenopausal women.
3. Duchesnay. (2023). DUAVEE Prescribing Information.
4. Market Research Future. (2022). Menopause Therapy Market Reports.