Bazedoxifene acetate; estrogens, conjugated - Generic Drug Details

What are the generic sources for bazedoxifene acetate; estrogens, conjugated and what is the scope of freedom to operate?

Bazedoxifene acetate; estrogens, conjugated is the generic ingredient in one branded drug marketed by Wyeth Pharms and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bazedoxifene acetate; estrogens, conjugated has twenty-two patent family members in twenty countries.

Two suppliers are listed for this compound.

Summary for bazedoxifene acetate; estrogens, conjugated

International Patents:	22
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	4
DailyMed Link:	bazedoxifene acetate; estrogens, conjugated at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for bazedoxifene acetate; estrogens, conjugated

Constraining patent/regulatory exclusivity:

7,683,051

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 bazedoxifene acetate; estrogens, conjugated

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

Sponsor	Phase
Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer	Phase 1

See all bazedoxifene acetate; estrogens, conjugated clinical trials

Pharmacology for bazedoxifene acetate; estrogens, conjugated

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

Anatomical Therapeutic Chemical (ATC) Classes for bazedoxifene acetate; estrogens, conjugated

G03XC	Selective estrogen receptor modulators
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 bazedoxifene acetate; estrogens, conjugated

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 bazedoxifene acetate; estrogens, conjugated

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 bazedoxifene acetate; estrogens, conjugated

Country	Patent Number	Title	Estimated Expiration
Peru	20060676	POLIMORFO CRISTALINO DE ACETATO DE BAZEDOXIFENO
Panama	8629101	POLIMORFO CRISTALINO DE ACETATO DE BAZEDOXIFENO
Canada	2561010	CORPS POLYMORPHE CRISTALLIN DE BASEDOXIFENE ACETATE (CRYSTALLINE POLYMORPH OF A BAZEDOXIFENE ACETATE)
Ukraine	85703	КРИСТАЛІЧНИЙ ПОЛІМОРФ БАЗЕДОКСИФЕНУ АЦЕТАТУ[КРИСТАЛЛИЧЕСКИЙ ПОЛИМОРФ БАЗЕДОКСИФЕНА АЦЕТАТА (CRYSTALLINE POLYMORPH OF BAZEDOXIFENE ACETATE)

Supplementary Protection Certificates for bazedoxifene acetate; estrogens, conjugated

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	2009/028	Ireland		PRODUCT NAME: BAZEDOXIFENE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/09/511/001-004 20090417
0802183	SPC/GB09/045	United Kingdom		PRODUCT NAME: BAZEDOXIFENE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/09/511/001 20090417; UK EU/1/09/511/002 20090417; UK EU/1/09/511/003 20090417; UK EU/1/09/511/004 20090417

Bazedoxifene acetate; estrogens, conjugated Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Conjugated Estrogens/Bazedoxifene

Introduction

Conjugated estrogens/bazedoxifene, marketed under the brand name Duavee, is a combination therapy designed to treat moderate to severe vasomotor symptoms associated with menopause and to prevent postmenopausal osteoporosis. This article delves into the market dynamics and financial trajectory of this drug.

Market Approval and Availability

Conjugated estrogens/bazedoxifene was approved by the U.S. Food and Drug Administration (FDA) in October 2013 and by the European Medicines Agency in December 2014[1][2][3].

• Global Reach: The drug is available in several countries, although its availability can vary. For instance, it is not yet available for certain indications in countries like Chile and Canada as of recent updates[3].

Therapeutic Indications and Effectiveness

The combination of conjugated estrogens and bazedoxifene is effective in:

• Relieving Vasomotor Symptoms: Reducing the number and severity of hot flashes.
• Vulvovaginal Atrophy: Decreasing pain with intercourse and reducing vaginal dryness.
• Preventing Osteoporosis: Maintaining or slightly increasing bone mineral density in the lumbar spine and hip[2][4].

Market Positioning

Competitive Landscape

Conjugated estrogens/bazedoxifene competes with other hormone replacement therapies (HRTs), such as conjugated estrogens/medroxyprogesterone. However, it offers several advantages:

• Simplified Regimen: Taken once daily without regard to meals.
• Better Tolerability: Lower dropout rates due to adverse effects compared to conjugated estrogens/medroxyprogesterone[2].

Patient Preference and Quality of Life

The drug improves menopause-related quality of life, sleep quality, and sexual functioning, which are significant factors in patient preference and adherence[2].

Safety and Risk Profile

While effective, conjugated estrogens/bazedoxifene comes with a boxed warning for increased risks of:

• Dementia in women older than 65 years.
• Endometrial Cancer: Although bazedoxifene reduces this risk by acting as an estrogen receptor antagonist in the uterus.
• Stroke and Deep Venous Thrombosis: Similar to other estrogen therapies[2].

Financial Considerations

Cost and Pricing

A one-month supply of conjugated estrogens/bazedoxifene costs approximately $145, which is comparable to other HRTs like conjugated estrogens/medroxyprogesterone ($148) but significantly higher than cyclical combined hormone replacement therapies ($10 per month)[2].

Revenue and Market Share

The financial performance of Duavee is influenced by its market share within the HRT segment. While specific revenue figures are not provided in the sources, the drug's unique combination and favorable safety profile contribute to its market presence.

Pharmacokinetics and Pharmacodynamics

Understanding the pharmacokinetics and pharmacodynamics is crucial for its market positioning:

• Pharmacokinetics: The exposure of both bazedoxifene and conjugated estrogens increases approximately two times after multiple doses compared to single doses[5].
• Pharmacodynamics: Bazedoxifene's effect on bone mineral density is dose-dependent, and the combination product maintains bone health without significant adverse effects on breast density[5].

Clinical Trials and Research

The drug's efficacy and safety were evaluated in several phase 3 studies, including the SMART trials, which involved over 7,000 patients. These trials demonstrated its effectiveness in relieving menopausal symptoms and preventing osteoporosis while maintaining endometrial and breast safety[1][2][5].

Regulatory Environment

The regulatory environment plays a critical role in the market dynamics:

• FDA Approval: The FDA approved Duavee with specific indications and warnings.
• International Approvals: Approvals in Europe and other regions have expanded its global reach[1][2][3].

Challenges and Opportunities

Challenges

• Safety Concerns: The drug carries risks similar to other estrogen therapies, which can impact market acceptance.
• Limited Research: There is not enough research to directly evaluate its effect on thrombotic or cardiovascular events beyond two years[2].

Opportunities

• Growing Demand: The increasing population of postmenopausal women presents a growing market.
• Differentiation: Its unique combination and favorable safety profile offer a competitive edge[2].

Key Takeaways

• Conjugated estrogens/bazedoxifene is effective for treating menopausal symptoms and preventing osteoporosis.
• It offers a simplified regimen and better tolerability compared to some other HRTs.
• The drug comes with specific safety warnings but has a favorable profile in many aspects.
• Its market positioning is strong due to its unique combination and clinical trial data.
• Financially, it is competitive in pricing but offers significant health benefits.

FAQs

What are the primary indications for conjugated estrogens/bazedoxifene?

Conjugated estrogens/bazedoxifene is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause and the prevention of postmenopausal osteoporosis[2].

How does bazedoxifene work in conjunction with conjugated estrogens?

Bazedoxifene acts as a selective estrogen receptor modulator (SERM), stimulating estrogen receptors in bone while having antagonistic effects in the breast and uterus, thereby reducing the risk of endometrial hyperplasia and breast density changes[2][4].

What are the common side effects of conjugated estrogens/bazedoxifene?

Common side effects include vaginal bleeding, although it is less frequent compared to conjugated estrogens/medroxyprogesterone. About 8% of patients may stop taking the medication in the first year due to adverse effects[2].

Is conjugated estrogens/bazedoxifene safe for women with a history of breast cancer?

No, conjugated estrogens/bazedoxifene should not be used in patients with breast cancer or estrogen-dependent neoplasia due to the risks associated with estrogen agonists/antagonists[2].

How much does a one-month supply of conjugated estrogens/bazedoxifene cost?

A one-month supply of conjugated estrogens/bazedoxifene costs approximately $145[2].

Cited Sources

1. Pooled Analysis of the Effects of Conjugated Estrogens/Bazedoxifene on Lipid Parameters in Nonhysterectomized Postmenopausal Women. Journal of Clinical Endocrinology and Metabolism.
2. Conjugated Estrogens/Bazedoxifene (Duavee) for Menopausal Symptoms. American Family Physician.
3. Conjugated estrogens/bazedoxifene - Ligand Pharmaceuticals/Pfizer. AdisInsight.
4. Product Information for conjugated estrogens / bazedoxifene acetate. Therapeutic Goods Administration.
5. 022247Orig1s000 - accessdata.fda.gov. FDA.