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DUAVEE Drug Patent Profile

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

Duavee is a drug marketed by Wyeth Pharms and is included in one NDA. There are two patents 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:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	12
Patent Applications:	5
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
The John B. Pierce Laboratory	Phase 4
Penn State University	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 four 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	6,479,535		Y
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	7,138,392
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013	6,479,535

International Patents for DUAVEE

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

Country	Patent Number	Title	Estimated Expiration
Canada	2203078	2-PHENYL-1-[4-(2-AMINOETHOXY)-BENZYL]INDOLES EN TANT QU'AGENTS OESTROGENIQUES (2-PHENYL-1-[4-(2-AMINOETHOXY)-BENZYL]INDOLES AS ESTROGENIC AGENTS)
Eurasian Patent Organization	001448	ПРОИЗВОДНЫЕ 2-ФЕНИЛ-1- [4-(2-АМИНОЭТОКСИ)БЕНЗИЛ] ИНДОЛА В КАЧЕСТВЕ ЭСТРОГЕННЫХ АГЕНТОВ (2-PHENYL-1-[4-(2-AMINOETHOXY)-BENZYL]-INDOLE COMPOUNDS AS ESTROGENIC AGENTS)
Mexico	9702865	AGENTES ESTROGENICOS. (2-PHENYL-1-[4-(2-AMINOETHOXY)-BENZYL]-IDOLES AS ESTROGENIC AGENTS.)
China	1170719
Japan	4093611
Taiwan	I346105
El Salvador	2008002080	POLIMORFO CRISTALINO DE ACETATO DE BAZEDOXIFENO REF. WYTH0084-504 (AM101551)

Supplementary Protection Certificates for DUAVEE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0802183	C00802183/01	Switzerland		PRODUCT NAME: BAZEDOXIFEN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58732 12.01.2010
0802183	91608	Luxembourg		91608, EXPIRES: 20220415
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
0802183	300416	Netherlands		300416, 20170415, EXPIRES: 20220414
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

DUAVEE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DUAVEE

Introduction

DUAVEE, a combination of conjugated estrogens and bazedoxifene, is a unique menopause hormone therapy approved by the U.S. Food and Drug Administration (FDA) in October 2013. This article delves into the market dynamics and financial trajectory of DUAVEE, highlighting its indications, safety profile, market availability, and financial performance.

Indications and Usage

DUAVEE is specifically designed for postmenopausal women with a uterus to address two primary health concerns:

• Moderate to Severe Hot Flashes: DUAVEE helps alleviate vasomotor symptoms associated with menopause[4].
• Prevention of Postmenopausal Osteoporosis: It aids in reducing the risk of developing thin, weak bones (osteoporosis)[4].

Unique Mechanism of Action

DUAVEE stands out from other hormone therapies because it pairs conjugated estrogens with bazedoxifene, a selective estrogen receptor modulator (SERM), instead of a progestin. This combination helps protect the uterine lining against hyperplasia that may result from estrogen-alone treatment[4].

Safety Profile and Contraindications

While DUAVEE offers significant benefits, it comes with important safety considerations:

• Blood Clots and Cardiovascular Risks: Estrogen alone may increase the chance of blood clots, strokes, and heart attacks[2].
• Cancer Risks: There is an increased risk of cancer of the uterus, breast, and ovary. Unusual vaginal bleeding should be reported immediately[2].
• Other Risks: Includes dementia, gallbladder problems, and various other medical conditions[2].

DUAVEE is contraindicated in women with certain conditions, such as blood clots, allergies to its ingredients, unusual vaginal bleeding, certain cancers, liver problems, or bleeding disorders. It is also not recommended for pregnant or breastfeeding women[4].

Market Availability and Packaging Updates

After a voluntary recall in May 2020 due to packaging issues, DUAVEE was reintroduced to the U.S. market in June 2023 with improved packaging. This recall was not based on any efficacy or safety concerns with the product itself but rather to ensure product stability throughout its shelf life[4].

Financial Performance and Market Impact

Revenue and Sales

DUAVEE is part of Pfizer's portfolio of women's health products. While specific revenue figures for DUAVEE are not separately detailed in Pfizer's financial reports, the overall performance of Pfizer's non-COVID products provides context. In 2023, Pfizer reported an 8% operational revenue growth for its non-COVID products, driven by new product launches and indications[3].

Cost Savings and Patient Access

To make DUAVEE more accessible, Pfizer offers a savings program. Eligible patients may pay as little as $25 per month, with savings up to $70 per prescription, up to 12 uses per calendar year[2].

Competitive Landscape

The menopause hormone therapy market is competitive, with various products available. However, DUAVEE's unique combination of conjugated estrogens and bazedoxifene sets it apart. The market dynamics are influenced by factors such as regulatory approvals, product recalls, and patient preferences.

Regulatory and Clinical Considerations

DUAVEE's approval and continued availability are subject to regulatory oversight. The FDA's approval in 2013 was based on clinical trials demonstrating its efficacy and safety profile. Ongoing monitoring and clinical studies continue to assess its long-term effects and risk biomarker modulation, particularly in relation to breast cancer risk[1].

Future Outlook

Pfizer's financial guidance for 2024 includes expectations of operational revenue growth, partly driven by the performance of newly launched and acquired products. While DUAVEE is not explicitly mentioned in these projections, its reintroduction with improved packaging and ongoing clinical assessments position it for continued market presence[3].

Key Takeaways

• Unique Mechanism: DUAVEE combines conjugated estrogens with bazedoxifene, a SERM, to protect the uterine lining.
• Indications: Reduces moderate to severe hot flashes and helps prevent postmenopausal osteoporosis.
• Safety Profile: Includes risks of blood clots, cardiovascular events, and certain cancers.
• Market Availability: Reintroduced in 2023 after a voluntary recall with improved packaging.
• Financial Performance: Part of Pfizer's growing non-COVID product portfolio, with cost savings programs to enhance patient access.

FAQs

Q: What are the primary indications for DUAVEE? A: DUAVEE is used to reduce moderate to severe hot flashes and to help prevent postmenopausal osteoporosis in women with a uterus[4].

Q: What makes DUAVEE unique compared to other hormone therapies? A: DUAVEE pairs conjugated estrogens with bazedoxifene, a SERM, instead of a progestin, to protect the uterine lining against hyperplasia[4].

Q: What are the significant safety concerns associated with DUAVEE? A: DUAVEE may increase the risk of blood clots, strokes, heart attacks, and certain cancers. It also includes risks such as dementia and gallbladder problems[2].

Q: How can patients save on DUAVEE prescriptions? A: Eligible patients may use the Duavee Savings Card to pay as little as $25 per month, with savings up to $70 per prescription[2].

Q: What was the reason for the voluntary recall of DUAVEE in 2020? A: The recall was due to an issue with the packaging to ensure product stability throughout its shelf life, not based on any efficacy or safety concerns with the product itself[4].

Sources

1. Effect of Bazedoxifene and Conjugated Estrogen (Duavee) on ... - AACR Journals
2. Save on DUAVEE® (conjugated estrogens/bazedoxifene) - Duavee.com
3. Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 ... - Pfizer
4. Pfizer Announces DUAVEE® (conjugated estrogens/bazedoxifene ... - Pfizer
5. CEO Letter - Pfizer 2013 Annual Review - Pfizer