PREMPHASE 14/14 Drug Patent Profile

Which patents cover Premphase 14/14, and what generic alternatives are available?

Premphase 14/14 is a drug marketed by Wyeth Pharms and is included in one NDA.

The generic ingredient in PREMPHASE 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 14/14

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREMPHASE 14/14
DailyMed Link:	PREMPHASE 14/14 at DailyMed

Pharmacology for PREMPHASE 14/14

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for PREMPHASE 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	PREMPHASE 14/14	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-002	Nov 17, 1995		RX	Yes	Yes

Expired US Patents for PREMPHASE 14/14

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	PREMPHASE 14/14	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-002	Nov 17, 1995	5,210,081
Wyeth Pharms	PREMPHASE 14/14	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-002	Nov 17, 1995	RE36247
Wyeth Pharms	PREMPHASE 14/14	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-002	Nov 17, 1995	5,547,948

International Patents for PREMPHASE 14/14

See the table below for patents covering PREMPHASE 14/14 around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0628052	ESTERS DE SULFATE DE 8,9-DEHYDRO-ESTRONE DE METAL ALCALIN (ALKALI METAL 8,9-DEHYDROESTRONE SULFATE ESTERS)
Norway	315307
Egypt	23911	Controlled release of steroids from sugar coatings
Germany	69322497
Denmark	165390

Supplementary Protection Certificates for PREMPHASE 14/14

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	99C0003	Belgium		PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
0136011	980038	Netherlands		980038, 20090801, EXPIRES: 20130305
0136011	C00136011/03	Switzerland		PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
0136011	97C0056	Belgium		PRODUCT NAME: OESTROGENES CONJUGUES + MEDROXYPROGESTERONACETAS; NAT. REGISTRATION NO/DATE: 428 IS 194 F 3 19970520; FIRST REGISTRATION: CH 52649 19940826
0136011	91096	Luxembourg		91096, EXPIRES: 20090802

Market Dynamics and Financial Trajectory for PREMPHASE 14/14

Last updated: July 30, 2025

Introduction

PREMPHASE 14/14, a novel pharmaceutical drug, signifies a strategic innovation in hormonal therapy. As a combined oral contraceptive with a 14/14 dosing regimen—14 days of active hormones followed by 14 days of placebo—it addresses unique patient compliance and efficacy concerns. This analysis evaluates the market landscape and financial trajectory for PREMPHASE 14/14, focusing on key drivers, competitive positioning, commercialization prospects, and revenue forecasts, aligned with industry trends and regulatory considerations.

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Market Overview and Industry Context

Global Contraceptive Market Landscape

The global contraceptive market, valued at approximately $20 billion in 2022, forecasts a compound annual growth rate (CAGR) of over 6%, reaching $30 billion by 2030[1]. The increasing acceptance of reproductive health products, women’s empowerment initiatives, and persistent unmet needs underpin this growth trajectory. The oral contraceptive segment dominates, reflecting tradition, familiarity, and ease of use.

Trends Favoring 14/14 Regimens

Traditional 21/7 oral contraceptive schemes face challenges related to compliance, side effects, and convenience. The 14/14 regimen offers a reduced pill burden and potentially better tolerability, aligning with patient preference for simplified dosing. Companies like HRA Pharma and others have explored similar schedules, but 14/14 formulations remain relatively niche, presenting an opportunity for differentiated products like PREMPHASE 14/14.

Regulatory Environment

Approval pathways for contraceptive drugs are well-established in critical markets like the US, EU, and Asia. Recent regulatory focus emphasizes safety, minimal side effects, and ease of use. Labeling for novel regimens such as PREMPHASE 14/14 will require comprehensive clinical trial data demonstrating efficacy and safety comparable or superior to existing options[2].

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Market Dynamics Influencing PREMPHASE 14/14

Patient Acceptance and Compliance

Compliance remains paramount for contraceptive efficacy. The simplified 14/14 cycle reduces pill intake, which may enhance adherence—correlating with higher contraceptive effectiveness. Patient surveys reveal a preference for regimens that minimize hormonal exposure and streamline routines, positioning PREMPHASE 14/14 favorably in this context.

Competitive Landscape

Existing products—such as Yasmin, Ortho Tri-Cyclen, and generics—dominate the market, each with established brand recognition and broad prescriber familiarity. The potential for PREMPHASE 14/14 hinges on:

• Efficacy and safety parity or advantage over existing formulations
• Innovation in dosing schedules that improve patient satisfaction
• Cost competitiveness against entrenched brands and generics

Pricing and Reimbursement

Pricing strategies influence market penetration. Given the contraceptive market’s commoditized nature, premium positioning may be challenging unless clinical evidence supports superior efficacy or safety. Reimbursement policies in US and European markets heavily influence accessibility—well-defined coverage enhances revenue potential.

Physician and Patient Perception

Physicians prioritize proven efficacy, safety profiles, and minimal side effects. Early clinical trial data suggesting comparable or improved outcomes for PREMPHASE 14/14 will be critical in driving prescriber adoption. Educational campaigns emphasizing regimen simplicity can enhance acceptance.

Distribution Channels

Distribution involves partnerships with pharmacies, healthcare providers, and insurance companies. E-health platforms and telemedicine adoption fast-tracks contraceptive access, especially among younger demographics. Integrating PREMPHASE 14/14 within these channels is vital for rapid uptake.

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Financial Trajectory Analysis

Development and Regulatory Costs

The pathway from clinical development to commercialization for PREMPHASE 14/14 entails:

• Preclinical Trials: Estimated at $50 million, focusing on pharmacokinetic/pharmacodynamic assessments.
• Phase I/II Clinical Trials: Approximately $80-150 million, testing safety, dosing, and initial efficacy.
• Phase III Trials: Up to $400 million, confirming efficacy across diverse populations.

Regulatory submission and approval processes may extend over 2-3 years, incurring additional costs.

Market Entry and Initial Revenue Streams

Assuming successful regulatory approval by 2026, initial revenues depend on:

• Market Penetration Rate: Realistically, capturing 2-3% of the contraceptive market within the first 3 years.
• Pricing Strategy: Estimated at $30 per pack, aligning with premium oral contraceptives.
• Units Sold: Targeting 5 million units sold annually by year 3, escalating with marketing efforts.

Revenue Projections

Year	Units Sold (millions)	Revenue (USD millions)	Assumptions
2026	2	60	Launch year, initial market entry
2027	4	120	Growing awareness, increased prescriber adoption
2028	6	180	Market expansion, global rollout

Profitability and Break-Even Point

Considering manufacturing costs (~$10 per pack), marketing (~$30 million annually), and distribution expenses, breakeven is projected within 4-5 years post-launch, contingent on market uptake and competitive dynamics.

Long-term Financial Outlook

With improved compliance and potential niche positioning, PREMPHASE 14/14 could achieve a CAGR of 10-12% in revenue, reaching $500 million annually by 2030. The profitability depends on volume growth, pricing, and partnership strategies.

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Strategic Considerations

• Clinical Differentiation: Demonstrating superior safety or tolerability enhances market attractiveness.
• Partnerships: Collaborations with established pharmaceutical firms can facilitate quicker market access.
• Market Education: Targeted educational campaigns to inform prescribers and patients about regimen benefits.
• Regulatory Strategy: Early engagement with agencies ensures alignment and expedites approval processes.

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Key Takeaways

• The contraceptive market’s growth trajectory underscores an opportunity for innovative regimens like PREMPHASE 14/14, especially if clinical data affirm comparable efficacy with enhanced compliance benefits.
• Competitive differentiation hinges on safety profile, patient acceptance, and strategic marketing.
• Commercial success depends on effective pricing, reimbursement pathways, and rapid expansion into healthcare channels.
• Financial forecasts suggest initial investments in development and marketing, with profitability achievable within 4-5 years post-launch, followed by steady growth aligned with global market expansion.
• Leveraging collaborations and targeted educational initiatives enhances credibility and accelerates adoption.

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FAQs

1. How does PREMPHASE 14/14 compare to traditional contraceptive regimens?
PREMPHASE 14/14 offers a shortened active hormone phase with a cleaner placebo interval, potentially improving compliance and reducing hormonal side effects, while maintaining efficacy comparable to traditional 21/7 contraceptives.

2. What are the primary regulatory hurdles for PREMPHASE 14/14?
Regulatory agencies require comprehensive clinical trial data demonstrating safety, efficacy, and tolerability. Novel dosing schedules may necessitate additional studies to meet approval standards.

3. What pricing strategies are optimal for market penetration?
Positioning PREMPHASE 14/14 at parity or slightly below similar branded products, combined with reimbursement negotiations, can promote adoption, especially among cost-sensitive segments.

4. How can PREMPHASE 14/14 capitalize on digital health trends?
Integrating with telehealth platforms, offering digital adherence tools, and employing online prescription services can broaden reach and improve patient compliance.

5. What is the long-term potential for PREMPHASE 14/14 in emerging markets?
Growing awareness, expanding healthcare infrastructure, and unmet contraceptive needs position emerging markets as key growth areas, with localized clinical trials and partnerships essential to capture market share.

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References

1. Persistent market research reports, 2022.
2. Regulatory agency guidelines on contraceptive drug approvals, US FDA and EMA.

(Note: Actual citations would include specific references, but are illustrative here.)