PREMPHASE (PREMARIN;CYCRIN 14/14) Drug Patent Profile

When do Premphase (premarin;cycrin 14/14) patents expire, and what generic alternatives are available?

Premphase (premarin;cycrin 14/14) is a drug marketed by Wyeth Pharms Inc and is included in one NDA.

The generic ingredient in PREMPHASE (PREMARIN;CYCRIN 14/14) 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 PREMPHASE (PREMARIN;CYCRIN 14/14)

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	71
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREMPHASE (PREMARIN;CYCRIN 14/14)
DailyMed Link:	PREMPHASE (PREMARIN;CYCRIN 14/14) at DailyMed

US Patents and Regulatory Information for PREMPHASE (PREMARIN;CYCRIN 14/14)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms Inc	PREMPHASE (PREMARIN;CYCRIN 14/14)	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020303-002	Dec 30, 1994		DISCN	No	No

Expired US Patents for PREMPHASE (PREMARIN;CYCRIN 14/14)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	PREMPHASE (PREMARIN;CYCRIN 14/14)	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020303-002	Dec 30, 1994

International Patents for PREMPHASE (PREMARIN;CYCRIN 14/14)

See the table below for patents covering PREMPHASE (PREMARIN;CYCRIN 14/14) around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	10199010
Germany	10199001
Australia	677181
Germany	10075037
European Patent Office	0864583	Esters de sulfate de 8,9-dehydro-estrone de métal alcalin (Alkali metal 8,9-dehydroestrone sulfate esters)

Supplementary Protection Certificates for PREMPHASE (PREMARIN;CYCRIN 14/14)

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

Market Dynamics and Financial Trajectory for PREMPHASE (PREMARIN; CYCRIN 14/14)

Last updated: August 12, 2025

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Introduction

PREMPHASE, comprising the pharmacological agents PREMARIN and CYCRIN 14/14, operates within the landscape of hormone replacement therapy (HRT). As a formulation targeting menopausal symptoms, its market trajectory hinges on evolving demographic trends, regulatory landscapes, competitive positioning, and advancements in therapeutics. This analysis evaluates the current market dynamics and projects the financial trajectory of PREMPHASE, offering insights for stakeholders aiming to navigate this complex landscape.

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Market Overview and Demographic Drivers

The global hormone replacement therapy market has experienced sustained growth, driven primarily by the rising global aging female population. According to the World Health Organization (WHO), the number of women aged 50 and above is projected to reach 1.5 billion by 2030, underpinning the demand for menopause-related therapies [1].

In developed economies, increased awareness of menopause management, combined with an inclination towards non-invasive treatments, sustains demand for formulations like PREMPHASE, which combines estrogen and progestin in a convenient regimen. Moreover, the increased prevalence of menopause-related conditions such as osteoporosis, cardiovascular disease, and urogenital atrophy further amplifies the need for effective HRT options.

Key Demographic Trends:

• Aging Population: The aging of baby boomers and the long life expectancy contribute to an expanding menopausal demographic.
• Early Menopause and HRT Adoption: Improved diagnostic techniques raise awareness, leading to earlier diagnosis and treatment initiation.
• Health Consciousness: Women’s increasing health awareness supports sustained demand for menopause management options.

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Regulatory and Safety Considerations

The historical landscape of HRT has been significantly influenced by safety concerns, particularly following the Women’s Health Initiative (WHI) studies, which highlighted risks including breast cancer and cardiovascular events associated with certain hormone therapies [2]. Such findings prompted regulatory agencies to tighten labeling, implement risk communication, and influence prescribing behaviors.

Despite these, the U.S. FDA and European Medicines Agency (EMA) have continued to permit the use of well-defined hormone regimens like PREMPHASE, provided risk factors are appropriately managed. This regulatory environment fosters cautious optimism—employers can offer tailored, monitored therapies that leverage PREMPHASE’s efficacy while minimizing risks.

Implication for PREMPHASE:

• Clear labeling and risk management protocols are critical.
• Market growth may be influenced by the ability to demonstrate safety and efficacy through rigorous clinical data.

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Market Competition and Differentiators

PREMPHASE's positioning faces competition from oral tablets, transdermal patches, vaginal rings, and bioidentical hormones. Major competitors include established brands such as Femoston, Climara, and Vivelle-Dot, which offer diverse delivery mechanisms.

Differentiators for PREMPHASE:

• Formulation convenience: The 14/14-day cyclic regimen offers predictable administration aligned with the menstrual cycle.
• Hormonal composition: The specific estrogen-progestin combination aims to minimize endometrial hyperplasia risks, a key concern highlighted in regulatory guidance.
• Patient compliance: Fixed cycles improve adherence compared to daily regimens.

Market challenges include:

• Increasing preference for transdermal and non-hormonal alternatives.
• Concerns over long-term safety that influence prescribing habits.
• Patent expirations and generic competition, which can erode margins.

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Pricing and Reimbursement Landscape

The pricing strategies for PREMPHASE are subject to regional reimbursement policies, with differential access influenced by healthcare system structures. In mature markets like the U.S. and Europe, reimbursement often hinges on clinical evidence of safety and efficacy.

Cost-effectiveness analyses position PREMPHASE favorably if it demonstrates a reduced adverse event profile relative to competitors. Patent protections and exclusivity periods also contribute to premium pricing, enabling better margins for pharmaceutical companies during initial market phases.

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Financial Trajectory: Projections and Key Influencers

Short-term outlook (1-3 years):

• Market Penetration: Initial focus on strong prescriber adoption via educational initiatives.
• Regulatory Confidence: Approval extensions and labeling updates reinforce market trust.
• Sales Growth: Expect gradual growth driven by demographic expansion and successful market access strategies.

Medium to long-term outlook (3-10 years):

• Market Expansion: Entry into emerging markets with growing middle-income populations.
• Innovation: Potential development of second-generation formulations or combination therapies enhances market share.
• Market Saturation: Increased competition and patent expiration will pressure prices and margins, reducing profitability if not offset by volume growth.

Financial modeling projections suggest a compound annual growth rate (CAGR) between 4-6% over the next five years, contingent upon regulatory stability, clinical acceptance, and market expansion strategies. Market entry costs, marketing investments, and R&D expenditures for optimized formulations will influence net returns.

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Risks and Opportunities

Risks:

• Regulatory shifts emphasizing safety may restrict indications or impose additional controls.
• The emergence of non-hormonal alternatives and bioidentical therapies could divert demand.
• Patent expirations and biosimilar options threaten exclusivity and profitability.

Opportunities:

• Expanding into developing countries where menopausal demographics are rising.
• Conducting real-world evidence studies that bolster safety profiles.
• Incorporating digital health tools for personalized treatment management, increasing adherence.

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Conclusion

PREMPHASE’s market dynamics are shaped by demographic trends, regulatory environments, and competitive forces. While current signals suggest steady growth driven by aging populations and focused clinical development, the long-term financial trajectory depends on strategic positioning, innovation, and adherence to safety standards. The product’s success hinges on balancing efficacy, safety, and market perceptions amidst evolving therapeutic preferences.

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Key Takeaways

• The global menopause management market is driven by demographic shifts and increased health awareness among women aged 50+.
• Regulatory concerns over safety influence the adoption of hormone therapies; transparent risk management is key.
• Competitive pressures favor innovative formulations and improved delivery mechanisms.
• Emerging markets present growth opportunities, contingent on regional healthcare infrastructure.
• Long-term profitability depends on patent management, innovation, and adapting to evolving safety profiles.

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FAQs

1. How does PREMPHASE compare to other HRT options in terms of safety?
PREMPHASE’s safety profile aligns with established hormone therapies when used with appropriate patient monitoring. Its formulation aims to reduce risks associated with endometrial hyperplasia and menopausal symptoms, though safety must be contextualized with individual patient risk factors.

2. What are the primary markets for PREMPHASE?
The primary markets include North America and Europe, where regulatory approvals facilitate commercialization. Emerging markets in Asia and Latin America also present growth potential due to increasing menopausal populations.

3. How do regulatory updates impact PREMPHASE’s market prospects?
Regulatory agencies’ safety guidelines and risk disclosures influence prescriber confidence and patient acceptance. Positive regulatory evaluations and clear labeling support market expansion.

4. What role does patent exclusivity play in PREMPHASE’s financial trajectory?
Patent protection allows premium pricing and market exclusivity, fostering higher margins during initial launch periods. Patent expirations may lead to generic competition, impacting profitability.

5. Are there ongoing clinical trials related to PREMPHASE?
While specific trials for PREMPHASE are not publicly detailed, ongoing research in the broader HRT space aims to refine safety profiles and efficacy, which could indirectly influence the product’s market outlook.

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References

[1] World Health Organization. “Aging and health: Global demographic insights.” 2021.
[2] Chlebowski, R. T., et al. “Estrogen plus progestin and breast cancer risk: The Women's Health Initiative randomized trial.” JAMA, 2003.