Estrogens, conjugated - Generic Drug Details

What are the generic drug sources for estrogens, conjugated and what is the scope of patent protection?

Estrogens, conjugated is the generic ingredient in twelve branded drugs marketed by Wyeth Pharms, Teva Womens, Aspen, Wyeth Pharms Inc, Medpointe Pharm Hlc, and Wyeth Ayerst, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for estrogens, conjugated

US Patents:	0
Tradenames:	12
Applicants:	6
NDAs:	10
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	61
Patent Applications:	2,712
What excipients (inactive ingredients) are in estrogens, conjugated?	estrogens, conjugated excipients list
DailyMed Link:	estrogens, conjugated at DailyMed

Recent Clinical Trials for estrogens, conjugated

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

Sponsor	Phase
VA Office of Research and Development	Phase 2
Carol Fabian, MD	Early Phase 1
University of Kansas Medical Center	Phase 2

See all estrogens, conjugated clinical trials

Pharmacology for estrogens, conjugated

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for estrogens, conjugated

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-001	Dec 20, 2004		DISCN	No	No
Aspen	CENESTIN	estrogens, conjugated synthetic a	TABLET;ORAL	020992-004	Mar 13, 2000		DISCN	Yes	No
Wyeth Pharms	PREMARIN	estrogens, conjugated	TABLET;ORAL	004782-006	Jul 16, 2003		RX	Yes	No
Wyeth Pharms	PREMPHASE 14/14	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-002	Nov 17, 1995		RX	Yes	Yes
Aspen	CENESTIN	estrogens, conjugated synthetic a	TABLET;ORAL	020992-003	Mar 24, 1999		DISCN	Yes	No

Expired US Patents for estrogens, conjugated

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	PREMARIN	estrogens, conjugated	TABLET;ORAL	004782-005	Jan 26, 1984
Wyeth Pharms	PREMARIN	estrogens, conjugated	CREAM;TOPICAL, VAGINAL	020216-001	Approved Prior to Jan 1, 1982
Wyeth Pharms	PREMARIN	estrogens, conjugated	TABLET;ORAL	004782-002	Approved Prior to Jan 1, 1982
Wyeth Pharms	PREMARIN	estrogens, conjugated	TABLET;ORAL	004782-001	Approved Prior to Jan 1, 1982
Wyeth Pharms	PREMARIN	estrogens, conjugated	TABLET;ORAL	004782-004	Approved Prior to Jan 1, 1982

Estrogens, conjugated Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Conjugated Estrogens

Introduction

Conjugated estrogens, a cornerstone in hormone replacement therapy (HRT), have a complex and dynamic market landscape influenced by various factors including demographic shifts, medical research advancements, and regulatory changes. Here, we delve into the market dynamics and financial trajectory of conjugated estrogens.

Historical Context

Conjugated estrogens were first introduced in the 1930s, with significant milestones including the FDA approval of diethylstilbestrol in 1941 and conjugated equine estrogens (CEE) in 1942 for treating menopausal symptoms[1].

Market Growth and Decline

The use of conjugated estrogens saw a surge in the mid-1960s to mid-1970s, driven by their efficacy in managing menopausal symptoms and preventing osteoporosis. However, reports of increased endometrial cancer in estrogen users in 1975 led to a dramatic decline in their use. The introduction of progestins to mitigate these risks and subsequent studies highlighting the protective effects of combined therapy led to a resurgence in the 1980s and 1990s[1].

Impact of Clinical Trials

The Women's Health Initiative (WHI) report in 2002, which indicated greater harm than benefit from combined CEE plus progestin therapy, resulted in a precipitous decline in the use of conjugated estrogens. This led to a reevaluation of HRT and increased interest in alternative approaches, including bioidentical hormones[1].

Current Market Trends

Despite past setbacks, the market for conjugated estrogens is experiencing substantial growth. The global hormone replacement therapy (HRT) market, driven by the increasing prevalence of menopause and related conditions, is expected to expand significantly between 2024 and 2030. North America is anticipated to dominate this market, fueled by demographic shifts, advancements in medical research, and favorable reimbursement policies[3].

Demographic Drivers

The aging population, particularly in developed countries, is a primary driver of growth in the HRT market. As the global population ages, the incidence of menopause and related conditions rises, increasing the demand for effective treatment options like conjugated estrogens[3].

Regulatory and Product Developments

The FDA has approved various formulations, doses, and routes of administration for conjugated estrogens, providing multiple options for women seeking conventional therapy. Recent product launches, such as the relaunch of DUAVEE® (conjugated estrogens/bazedoxifene) by Pfizer Inc. in 2023, further bolster market expansion[3][4].

Economic Impact

Studies have shown that the use of conjugated estrogens can lead to significant cost savings in healthcare. A pharmacoeconomic analysis revealed that women prescribed oral conjugated estrogens experienced a greater reduction in healthcare costs compared to untreated women, particularly in inpatient stay costs[2].

Financial Trajectory

The financial trajectory of conjugated estrogens is closely tied to the overall HRT market. With a projected Compound Annual Growth Rate (CAGR) of 6% by 2030, the market is expected to see substantial financial growth. Key players such as Abbott, Novartis AG, Pfizer Inc., and others are driving this growth through new product launches, collaborative agreements, and significant investments in research and development[3].

Competitive Landscape

The HRT market is highly competitive, with numerous players vying for market share. Companies like Pfizer Inc., Merck KGaA, Bayer AG, and others are actively involved in developing and marketing various HRT products, including conjugated estrogens. This competition drives innovation and expands the range of treatment options available to patients[3].

Challenges and Opportunities

Despite the growth potential, the market for conjugated estrogens faces challenges such as the need for continuous clinical surveillance to manage risks like endometrial hyperplasia and breast cancer. However, advancements in medical research and the development of new formulations offer opportunities for improved safety and efficacy profiles[4][5].

Consumer Awareness and Quality of Life

There is a growing recognition of the importance of maintaining quality of life during aging, leading more women to seek medical interventions like HRT to manage menopause symptoms. This increased awareness and demand for effective treatments are key drivers of the market's growth trajectory[3].

Regulatory Environment

FDA guidelines and approvals play a crucial role in shaping the market dynamics of conjugated estrogens. The approval of various formulations and the ongoing monitoring of safety and efficacy ensure that the market remains dynamic and responsive to patient needs[1][4].

Future Outlook

The future outlook for conjugated estrogens is promising, driven by demographic trends, advancements in medical research, and the active involvement of key market players. As the global population ages and awareness about menopause management increases, the demand for conjugated estrogens and other HRT products is expected to continue growing.

Key Takeaways

• Market Growth: The HRT market, including conjugated estrogens, is expected to grow substantially between 2024 and 2030.
• Demographic Drivers: The aging population is a primary driver of growth in the HRT market.
• Economic Impact: Conjugated estrogens can lead to significant healthcare cost savings.
• Regulatory Environment: FDA approvals and guidelines are crucial in shaping market dynamics.
• Competitive Landscape: The market is highly competitive with numerous key players driving innovation.

FAQs

Q: What are the primary drivers of the hormone replacement therapy (HRT) market? A: The primary drivers include the aging population, advancements in medical research, and increased awareness about menopause management.

Q: How have clinical trials impacted the use of conjugated estrogens? A: Clinical trials, such as the WHI report in 2002, have significantly impacted the use of conjugated estrogens by highlighting potential risks and benefits, leading to a reevaluation of HRT.

Q: What are the economic benefits of using conjugated estrogens? A: Studies have shown that women prescribed oral conjugated estrogens experience a greater reduction in healthcare costs, particularly in inpatient stay costs.

Q: Which region is expected to dominate the HRT market? A: North America is anticipated to dominate the global HRT market during the forecast period from 2024 to 2030.

Q: What are some of the challenges faced by the conjugated estrogens market? A: Challenges include the need for continuous clinical surveillance to manage risks like endometrial hyperplasia and breast cancer, as well as the ongoing need for regulatory approvals and monitoring.

Sources

1. Estrogens and progestins: background and history, trends in use ... - PubMed
2. Pharmacoeconomic and associated cost savings among ... - PubMed
3. Global Hormone Replacement Therapy Market to Grow ... - PR Newswire
4. Conjugated Estrogens - Elsevier healthcare hub
5. Premarin (conjugated estrogens) Vaginal Cream - FDA