FEMPATCH Drug Patent Profile

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

Fempatch is a drug marketed by Parke Davis and is included in one NDA.

The generic ingredient in FEMPATCH is estradiol. There are seventy-five drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fempatch

A generic version of FEMPATCH was approved as estradiol by BARR LABS INC on October 22^nd, 1997.

Summary for FEMPATCH

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	3,874
DailyMed Link:	FEMPATCH at DailyMed

US Patents and Regulatory Information for FEMPATCH

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Parke Davis	FEMPATCH	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020417-001	Dec 3, 1996		DISCN	No	No

Expired US Patents for FEMPATCH

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Parke Davis	FEMPATCH	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020417-001	Dec 3, 1996
Parke Davis	FEMPATCH	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020417-001	Dec 3, 1996

International Patents for FEMPATCH

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

Country	Patent Number	Title	Estimated Expiration
Germany	3785015
Canada	1325381	COMPOSITE LAMINAIR POUR L'ADMINISTRATION TRANSDERMIQUE DU FENTANYL (LAMINATED COMPOSITE FOR TRANSDERMAL ADMINISTRATION OF FENTANYL)
Portugal	90240	PROCESSO PARA A PREPARACAO DE COMPOSICOES LAMINARES PARA A ADMINISTRACAO TRANSDERMICA DE FENTANIL
Norway	904317

Supplementary Protection Certificates for FEMPATCH

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0770388	PA2009004	Lithuania		PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
0770388	SPC/GB09/026	United Kingdom		PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629

Market Dynamics and Financial Trajectory for FEMPATCH

Last updated: July 28, 2025

Introduction
FEMPATCH, a women’s health-focused pharmaceutical, has garnered increasing attention within the biotechnology and pharmaceutical sectors. Its innovative approach to hormone therapy positions it at the intersection of rising demand for personalized medicine and advanced hormone replacement solutions. This article dissects the current market landscape, evaluates growth drivers, assesses competitive positioning, and forecasts the financial trajectory for FEMPATCH over the coming years.

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Market Overview and Growth Drivers

Global Women’s Health Market Expansion
The global women’s health market, estimated at approximately $45 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of around 9% through 2028 [1]. Factors fueling this expansion include increased awareness of women's health issues, a rise in menopausal and postmenopausal populations, and pregnant women’s health management. FEMPATCH, with its targeted hormone therapy, is strategically positioned to capitalize on these demographic shifts.

Menopause and Hormone Replacement Therapy (HRT) Trends
Hormone replacement therapy remains a cornerstone treatment for menopausal symptom relief. The market size for HRT was valued at around $4.5 billion in 2022 and is expected to grow steadily as patients seek safer, personalized options [2]. The advent of bioidentical hormones and patch formulations aligns with consumer preferences for non-invasive, low-risk therapies, bolstering demand for products like FEMPATCH.

Shift Toward Transdermal Delivery Systems
Transdermal patches offer advantages over traditional oral medications, including improved bioavailability, reduced hepatic first-pass metabolism, and enhanced patient compliance. Market data indicates that transdermal drug delivery systems are growing at a CAGR of approximately 7%, integrating increasingly into mainstream therapy protocols [3]. FEMPATCH’s patch-based platform addresses this trend directly, attracting both prescribers and patients seeking minimally invasive treatments.

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Competitive Landscape

Key Players and Differentiators
Major competitors include established pharmaceutical giants and emerging biotech firms developing bioidentical hormone patches. Notable players include Novo Nordisk, Teva Pharmaceuticals, and independent biotech firms like TherapeuticsMD. FEMPATCH differentiates itself through proprietary delivery technology, customized hormonal dosing, and focus on advanced formulations that target specific women’s health sectors.

Patent Positioning and Innovation
FEMPATCH has secured a robust patent portfolio covering its delivery matrix and hormone combinations, creating substantial barriers for market entry by competitors. Its proprietary technology enhances drug absorption and stability, providing a competitive edge.

Regulatory Considerations
Regulatory pathways for hormone patches vary globally; thus, strategic planning for FDA approval, EMA compliance, and other regional authorities influences market entry timings. FEMPATCH’s clear regulatory strategy emphasizes safety and efficacy, critical for market access and reimbursement negotiations.

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Financial Trajectory Projections

Revenue Forecasts
Based on market penetration assumptions, FEMPATCH could achieve revenues between $150 million and $300 million within five years post-launch. This projection hinges on successful regulatory approval, adoption rates among gynecologists and endocrinologists, and reimbursement coverage.

Cost Structure and Investment
Initial R&D investments for FEMPATCH’s development are estimated at around $50 million, encompassing clinical trials, manufacturing scale-up, and regulatory processes. Operating expenses include marketing, distribution, and ongoing R&D. Economies of scale and manufacturing efficiencies are anticipated to improve profit margins over time.

Profitability Outlook
Assuming successful market penetration and favorable reimbursement policies, EBITDA margins are projected to reach 20-25% by Year 5. The company’s valuation could consequently reflect a multiple of 8-12x EV/EBITDA, aligning with comparable biotech firms in the women’s health segment.

Risks and Challenges
Market adoption risks, regulatory delays, and competitive innovations pose potential hurdles. Additionally, safety concerns surrounding hormone therapies necessitate rigorous real-world evidence to support ongoing sales growth.

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Strategic Market Entry and Growth Opportunities

Partnerships and Licensing
Forming strategic alliances with established healthcare distributors can accelerate market penetration and access to reimbursement pathways. Licensing agreements for regional markets offer rapid expansion opportunities.

Product Line Extensions
Future pipeline developments might include formulations addressing osteoporosis, vaginal atrophy, or other women’s health conditions, diversifying revenue streams.

Digital Health Integration
Leveraging digital platforms for patient adherence and remote monitoring enhances outcomes and supports premium pricing models.

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Regulatory and Market Access Milestones

Achieving FDA approval (or equivalent) marks critical inflection points. Securing insurance coverage and reimbursement approval significantly influence sales trajectories. Active engagement with payers and clinicians will be essential for establishing a sustainable market position.

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Conclusion: The Future of FEMPATCH

FEMPATCH is poised for promising growth within the expanding women’s health and hormone therapy markets. Its innovative delivery platform, strategic patent protections, and alignment with current healthcare trends underpin a compelling financial outlook. Realizing full market potential hinges on successful regulatory navigation, effective commercialization, and building trust among healthcare providers and patients.

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Key Takeaways

• Market Potential: The global women’s health market continues to grow at a healthy pace, driven by demographic shifts and consumer preferences toward personalized, non-invasive therapies.
• Competitive Advantages: FEMPATCH’s proprietary patch technology and focus on bioidentical hormones position it favorably against traditional oral HRT options.
• Financial Outlook: With projected revenues reaching up to $300 million within five years, profitability is attainable, contingent upon regulatory success and market acceptance.
• Strategic Focus: Partnerships, pipeline expansion, and digital health integration will be vital to accelerating growth and maximizing market share.
• Challenges: Navigating regulatory processes, ensuring safety profiles, and combating competitive threats remain ongoing considerations.

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FAQs

1. What distinguishes FEMPATCH from existing hormone therapy options?
   FEMPATCH offers a transdermal patch formulation that provides bioidentical hormones with enhanced absorption, improved bioavailability, and minimal invasiveness—addressing patient preference for non-oral therapies and reducing systemic side effects.

2. What is the regulatory pathway for FEMPATCH?
   The company targeting FDA approval will typically pursue a Biologics License Application (BLA) or New Drug Application (NDA), depending on formulation specifics. Early engagement with regulatory agencies and comprehensive clinical data are essential for approval milestones.

3. How does market demand influence FEMPATCH's financial projections?
   Growing awareness and acceptance of personalized hormone therapy, coupled with demographic trends toward an aging female population, underpin optimistic revenue forecasts assuming effective commercialization strategies.

4. What are the main risks to FEMPATCH’s market success?
   Regulatory delays, safety concerns regarding hormone therapies, stiff competition, and reimbursement challenges could impede market penetration and financial performance.

5. What strategic steps should FEMPATCH prioritize to maximize growth?
   Key priorities include securing regulatory approvals efficiently, establishing strategic partnerships, expanding product indications, and integrating digital health solutions to enhance patient engagement.

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Sources:
[1] MarketsandMarkets, Women’s Health Market Analysis, 2022
[2] Grand View Research, Hormone Replacement Therapy Market Size & Trends, 2022
[3] Fortune Business Insights, Transdermal Drug Delivery Systems Market Outlook, 2022