PREMPRO Drug Patent Profile

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

Prempro is a drug marketed by Wyeth Pharms and Wyeth Pharms Inc and is included in two NDAs.

The generic ingredient in PREMPRO is estrogens, conjugated; medroxyprogesterone acetate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estrogens, conjugated; medroxyprogesterone acetate profile page.

Summary for PREMPRO

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	14
Drug Prices:	Drug price information for PREMPRO
What excipients (inactive ingredients) are in PREMPRO?	PREMPRO excipients list
DailyMed Link:	PREMPRO at DailyMed

See drug prices for PREMPRO

See drug sales revenues for PREMPRO

Recent Clinical Trials for PREMPRO

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

Sponsor	Phase
Pfizer	Phase 3
MDS Pharma Services	Phase 1
Bayer	Phase 2

See all PREMPRO clinical trials

Pharmacology for PREMPRO

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for PREMPRO

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	020527-005	Jun 4, 2003		RX	Yes	Yes
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-003	Jan 9, 1998		RX	Yes	Yes
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-004	Mar 12, 2003		RX	Yes	Yes
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-001	Nov 17, 1995		RX	Yes	Yes
Wyeth Pharms Inc	PREMPRO (PREMARIN;CYCRIN)	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020303-001	Dec 30, 1994		DISCN	No	No

Expired US Patents for PREMPRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-001	Nov 17, 1995
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-003	Jan 9, 1998
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-004	Mar 12, 2003
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-001	Nov 17, 1995
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-005	Jun 4, 2003
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-001	Nov 17, 1995
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-003	Jan 9, 1998

International Patents for PREMPRO

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

Country	Patent Number	Title	Estimated Expiration
Finland	960210
New Zealand	299823	TABLET COMPRISING A SUGAR COATING CONTAINING A HORMONAL STEROID AND A STEROID RELEASE RATE CONTROLLING AMOUNT OF MICROCRYSTALLINE CELLULOSE
China	1141168
Germany	10199010
Germany	10199001
Australia	677181
Germany	10075037

Supplementary Protection Certificates for PREMPRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	980038	Netherlands		980038, 20090801, EXPIRES: 20130305
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0136011	91096	Luxembourg		91096, EXPIRES: 20090802
0136011	SPC/GB00/028	United Kingdom		SPC/GB00/028: 20040802, EXPIRES: 20090801
0136011	97C0056	Belgium		PRODUCT NAME: OESTROGENES CONJUGUES + MEDROXYPROGESTERONACETAS; NAT. REGISTRATION NO/DATE: 428 IS 194 F 3 19970520; FIRST REGISTRATION: CH 52649 19940826
0136011	SPC/GB98/034	United Kingdom		SPC/GB98/034: 20040802, EXPIRES: 20090801
0136011	SPC/GB00/025	United Kingdom		SPC/GB00/025: 20040802, EXPIRES: 20090801

Market Dynamics and Financial Trajectory of PREMPRO

Last updated: July 28, 2025

Introduction

PREMPRO, a hormone replacement therapy (HRT) combination drug, remains a significant product within the pharmaceutical landscape addressing menopausal symptoms. Comprising conjugated estrogens and medroxyprogesterone acetate, PREMPRO targets postmenopausal women experiencing estrogen deficiency, a common clinical scenario. This analysis explores the evolving market forces, regulatory environment, and financial prospects shaping PREMPRO’s trajectory.

Market Landscape Overview

The global menopausal therapy market, valued at approximately USD 15 billion in 2022, is projected to grow at a CAGR of 4.8% through 2030 [1]. This expansion is driven by increasing awareness of menopause-related health issues, rising aging populations, and a preference for hormone therapies over alternative remedies.

PREMPRO is positioned within a niche that faces intense generic competition but benefits from a substantial established patient population. Its primary competitors include brand alternatives like Premarin and other compounded HRT formulations, alongside emerging biosimilars.

Key Market Drivers

Aging Demographics and Women's Health Awareness

Advances in healthcare have extended life expectancy, amplifying menopausal health management needs. The global population of women aged 50 and above is expected to reach 1.2 billion by 2030 [2]. Rising health literacy and proactive menopause management bolster demand for effective hormonal interventions like PREMPRO.

Clinical Guidelines and Prescriber Preferences

The North American Menopause Society (NAMS) and other bodies endorse hormonotherapy for moderate to severe menopausal symptoms, reinforcing prescriber confidence. However, evolving guidelines emphasizing individualized therapy and risk assessment influence the selection and duration of treatment regimens.

Regulatory and Patent Dynamics

PREMPRO's patent exclusivity has historically delayed generic competition. However, patent expiration in recent years has intensified market entry of generics, exerting downward pressure on prices. The US Food and Drug Administration (FDA) continues to evaluate safety profiles to optimize regulatory pathways, including biosimilar approvals.

Safety and Risk Considerations

Material safety concerns surrounding HRT, particularly related to cardiovascular risk, breast cancer, and thromboembolic events, influence treatment acceptance. Regulatory warnings and public perception significantly impact market growth patterns.

Competitive Landscape

The proliferation of biosimilars and generics since patent expiry presents both challenges and opportunities. While price erosion caps revenue growth for branded PREMPRO, strategic differentiation through clinical efficacy and safety profiles can sustain market share.

Emerging treatments like selective estrogen receptor modulators (SERMs) and alternative non-hormonal therapies vie for market share, necessitating ongoing clinical differentiation.

Financial Trajectory and Revenue Outlook

Historical Performance

PREMPRO's peak sales occurred in the early 2010s, with annual revenue estimates surpassing USD 600 million in the US [3]. Subsequent patent expirations led to revenue erosion, with recent figures halving amidst competitive pressures.

Forecasted Revenue Trends

Analysts project that branded PREMPRO sales will stabilize over the next five years, averaging USD 200–300 million annually, primarily driven by ongoing demand among women who seek trusted hormone therapy options [4]. Growth avenues include:

• Market Expansion: Increasing penetration in untapped international markets, particularly in Asia and Latin America.
• Line Extensions: Potential development of formulations with reduced side-effect profiles or alternative delivery mechanisms.
• Regulatory Approvals: Approval of biosimilar counterparts could pressure pricing but may also expand market accessibility.

Cost Considerations and Pricing Strategies

Generic entrants’ price points have pressured margins. Companies are responding with tailored pricing strategies, including value-based frameworks emphasizing safety and efficacy to justify premium pricing where applicable.

Regulatory and Public Health Influences

Conformance with evolving guidelines on HRT safety, coupled with post-marketing surveillance, will influence market acceptability. Rising emphasis on personalized medicine supports potential shifts towards targeted therapies with reduced adverse events.

Government health policies, insurance reimbursements, and patient affordability significantly dictate sales trajectories, especially in markets where out-of-pocket costs dominate.

Risks and Opportunities

Risks

• Regulatory Scrutiny: Increased safety warnings can suppress demand.
• Market Saturation: Generics and biosimilars threaten revenue streams.
• Public Perception: Negative publicity about HRT safety impacts acceptance.

Opportunities

• Innovation: Developing safer formulations with improved side-effect profiles.
• Market Diversification: Expanding into emerging markets with growing menopausal populations.
• Brand Differentiation: Emphasizing clinical data and safety for sustained market share.

Conclusion

PREMPRO’s market dynamics are characterized by a complex interplay of demographic trends, regulatory frameworks, safety considerations, and competitive pressures. While patent expirations and generic competition have subdued revenue growth, strategic positioning, ongoing clinical development, and market expansion can sustain its financial trajectory. The product’s future hinges on balancing safety profiles, regulatory compliance, and market accessibility.

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Key Takeaways

• The global demand for menopausal hormone therapies continues to grow, driven by aging populations and increasing health awareness.
• Patent expirations have eroded PREMPRO’s market exclusivity, ushering in intensified competition from generics and biosimilars.
• Safety concerns and regulatory scrutiny significantly shape prescriber preferences and market acceptance.
• Revenue projections suggest stabilization with potential for targeted growth through market expansion and innovation.
• Strategic focus on safety, patient-centric formulations, and geographic diversification offers pathways to long-term financial sustainability.

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FAQs

1. How has patent expiration impacted PREMPRO's market share?
Patent expiration has led to increased generic competition, resulting in substantial price declines and decreased revenue for the branded PREMPRO.

2. What safety concerns influence the prescribing of PREMPRO?
Risks related to cardiovascular events, breast cancer, and thromboembolism have prompted regulatory warnings, affecting physician prescribing behaviors.

3. Are biosimilars a significant threat to PREMPRO?
Yes, biosimilars entering the market can offer lower-priced alternatives, exerting pressure on margins and market share.

4. What strategies can sustain PREMPRO’s market position?
Differentiation through improved safety profiles, geographic expansion, and clinical trial data emphasizing efficacy can help maintain competitiveness.

5. What is the outlook for PREMPRO in emerging markets?
Growing awareness, expanding healthcare infrastructure, and increasing menopausal populations present lucrative opportunities for product adoption.

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Sources
[1] Markets and Markets, Menopausal Therapy Market Analysis, 2022.
[2] United Nations Department of Economic and Social Affairs, World Population Prospects, 2022.
[3] IMS Health (IQVIA), Pharmaceutical Sales Data, 2022.
[4] Analyst Reports, Healthcare Market Insights, 2023.