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Last Updated: December 22, 2024

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - Generic Drug Details

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

Estrogens, conjugated; medroxyprogesterone acetate is the generic ingredient in four branded drugs marketed by Wyeth Pharms Inc and Wyeth Pharms, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

US Patents:	0
Tradenames:	4
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	6
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
DailyMed Link:	ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE at DailyMed

Recent Clinical Trials for ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

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

Sponsor	Phase
Far Eastern Memorial Hospital	Phase 4
Selmo Geber	N/A
Erasmus Medical Center	Phase 4

See all ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE clinical trials

Pharmacology for ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

US Patents and Regulatory Information for ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-004	Mar 12, 2003		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-001	Nov 17, 1995		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Wyeth Pharms Inc	PREMPHASE (PREMARIN;CYCRIN 14/14)	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020303-002	Dec 30, 1994		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Wyeth Pharms Inc	PREMPRO (PREMARIN;CYCRIN)	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020303-001	Dec 30, 1994		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-005	Jun 4, 2003		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-003	Jan 9, 1998		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Wyeth Pharms	PREMPHASE 14/14	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-002	Nov 17, 1995		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-004	Mar 12, 2003	⤷ Subscribe	⤷ Subscribe
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-003	Jan 9, 1998	⤷ Subscribe	⤷ Subscribe
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-001	Nov 17, 1995	⤷ Subscribe	⤷ Subscribe
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-005	Jun 4, 2003	⤷ Subscribe	⤷ Subscribe
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-004	Mar 12, 2003	⤷ Subscribe	⤷ Subscribe
Wyeth Pharms Inc	PREMPHASE (PREMARIN;CYCRIN 14/14)	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020303-002	Dec 30, 1994	⤷ Subscribe	⤷ Subscribe
Wyeth Pharms Inc	PREMPRO (PREMARIN;CYCRIN)	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020303-001	Dec 30, 1994	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Conjugated Estrogens; Medroxyprogesterone Acetate

Introduction

Conjugated estrogens and medroxyprogesterone acetate are widely used in hormone replacement therapy (HRT) for postmenopausal women, addressing symptoms such as vasomotor and genitourinary issues, and preventing osteoporosis. Here, we delve into the market dynamics and financial trajectory of this drug combination.

Market Overview

The market for conjugated estrogens and medroxyprogesterone acetate is part of the broader hormone replacement therapy market. This segment has seen significant fluctuations due to changing medical guidelines, safety concerns, and evolving patient preferences.

Historical Context

The FDA approved the first combination products of conjugated estrogens and medroxyprogesterone acetate in November 1995. Initially, these products were well-received due to their efficacy in reducing menopausal symptoms and the risk of endometrial hyperplasia when used in women with an intact uterus[1].

Safety Concerns and Regulatory Impact

A pivotal moment in the market dynamics of these drugs was the release of the Women's Health Initiative (WHI) study findings. The WHI reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women using conjugated estrogens combined with medroxyprogesterone acetate[4][5].

These findings led to a significant decline in prescriptions and a shift in medical guidelines. The FDA and other regulatory bodies emphasized the use of these drugs at the lowest effective doses and for the shortest duration consistent with treatment goals and individual patient risks.

Market Impact of Safety Concerns

The publication of the WHI study results in the early 2000s led to a substantial drop in sales for conjugated estrogens and medroxyprogesterone acetate products. This decline was due to both reduced prescriptions and increased caution among healthcare providers and patients.

Financial Consequences

The financial impact was marked, with a notable decrease in revenue for pharmaceutical companies manufacturing these products. For instance, the sales of Prempro and Premphase, two popular brands, significantly declined following the WHI study's release.

Current Market Trends

Despite the initial decline, the market has stabilized to some extent. There is a growing recognition of the need for personalized HRT, with a focus on individual risk-benefit assessments. This shift has led to the development and marketing of lower-dose formulations and alternative delivery methods.

Personalized Medicine

The trend towards personalized medicine has helped in reviving the market to some extent. Studies have shown that low-dose continuous combined HRT can be effective in managing menopausal symptoms while minimizing risks[2].

Generic and Biosimilar Competition

The expiration of patents for branded products like Prempro and Premphase has opened the market to generic and biosimilar competitors. This competition has driven down prices, making these medications more accessible but also reducing the revenue for original manufacturers.

Financial Trajectory

The financial trajectory of conjugated estrogens and medroxyprogesterone acetate products can be summarized as follows:

Peak and Decline

Peak Sales: The early 2000s saw peak sales for these products before the WHI study's findings were released.
Decline: Following the WHI study, sales plummeted due to safety concerns and changes in medical guidelines.

Stabilization and Adaptation

Stabilization: The market has since stabilized, with a focus on lower-dose formulations and personalized treatment plans.
Adaptation: Pharmaceutical companies have adapted by developing new delivery methods and emphasizing the benefits of HRT in specific patient populations.

Future Outlook

The future outlook for conjugated estrogens and medroxyprogesterone acetate is mixed:

Positive Factors

Aging Population: The increasing age of the global population is likely to drive demand for HRT.
Advancements in Formulations: New formulations and delivery methods may improve safety and efficacy profiles.

Challenges

Safety Concerns: Ongoing safety concerns and the need for careful risk-benefit assessments will continue to influence market dynamics.
Regulatory Environment: Changes in regulatory guidelines and recommendations from health organizations will remain crucial in shaping the market.

Key Takeaways

The market for conjugated estrogens and medroxyprogesterone acetate has been significantly impacted by safety concerns and regulatory changes.
Despite initial declines, the market has stabilized with a focus on personalized medicine and lower-dose formulations.
The future outlook is influenced by an aging population, advancements in formulations, and ongoing safety and regulatory considerations.

FAQs

Q: What are the primary uses of conjugated estrogens and medroxyprogesterone acetate?

A: These drugs are used to treat vasomotor and genitourinary symptoms associated with menopause and to prevent osteoporosis.

Q: What were the key findings of the Women's Health Initiative (WHI) study regarding these drugs?

A: The WHI study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women using these drugs.

Q: How have safety concerns impacted the market for these drugs?

A: Safety concerns led to a significant decline in prescriptions and a shift in medical guidelines, emphasizing the use of these drugs at the lowest effective doses and for the shortest duration.

Q: What are the current trends in the market for these drugs?

A: There is a growing focus on personalized medicine, lower-dose formulations, and alternative delivery methods.

Q: What is the future outlook for the market of conjugated estrogens and medroxyprogesterone acetate?

A: The future outlook is mixed, influenced by an aging population, advancements in formulations, and ongoing safety and regulatory considerations.

Sources

Elsevier Health: Conjugated Estrogens; Medroxyprogesterone.
PubMed: Effects of Low-Dose Continuous Combined Conjugated Estrogens ...
FDA: Prempro™ and Premphase® (conjugated estrogens ...
FDA: PREMPRO™ (conjugated estrogens/medroxyprogesterone ...
FDA: Prempro™ and Premphase® (conjugated estrogens ...

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