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-seven 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:	4,122
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	4,906,463
Parke Davis	FEMPATCH	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020417-001	Dec 3, 1996	5,006,342

International Patents for FEMPATCH

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

Country	Patent Number	Title	Estimated Expiration
Portugal	101320	DISPOSITIVO RESILIENTE PARA ADMINISTRACAO DE UM MEDICAMENTO POR VIA TRANSDERMICA E PROCESSO PARA A PREPARACAO DE UMA COMPOSICAO FARMACEUTICA PARA ADMINISTRACAO DE UM MEDICAMENTO POR VIA TRANSDERMICA
Spain	2039471
Norway	904317
Austria	87202
Japan	H03504977

Supplementary Protection Certificates for FEMPATCH

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
0136011	99C0003	Belgium		PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
2782584	122021000080	Germany		PRODUCT NAME: ZUSAMMENSETZUNG, DIE SOWOHL ESTRADIOL (17SS-ESTRADIOL), GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON (EINSCHLIESSLICH IN FORM EINES HEMIHYDRATS), ALS AUCH PROGESTERON ENTHAELT; NAT. REGISTRATION NO/DATE: 2205034.00.00 20210924; FIRST REGISTRATION: BELGIEN BE582231 20210406
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307

Market Dynamics and Financial Trajectory for FEMPATCH

Last updated: February 20, 2026

What is the current market landscape for FEMPATCH?

FEMPATCH, a drug developed for hormone-responsive breast cancer, is positioned in the targeted oncology segment. The global breast cancer therapeutics market was valued at approximately USD 23 billion in 2022. The demand for hormone receptor modulators and targeted therapies drives growth in this sector.

Major competitors include Novartis, AstraZeneca, and Pfizer, which dominate the endocrine therapy and selective estrogen receptor modulator (SERM) markets. FEMPATCH’s potential market share depends on its differentiation, efficacy, and safety profile relative to existing treatments such as tamoxifen, fulvestrant, and aromatase inhibitors.

Key factors influencing market dynamics include:

• Increasing breast cancer incidence rates, projected to reach 3.2 million cases globally by 2040 (GLOBOCAN, 2020).
• Growing adoption of targeted therapies, especially following recent FDA approvals.
• Patent expirations of older therapies, opening opportunities for new entrants like FEMPATCH.

How does regulatory status impact FEMPATCH's financial outlook?

FEMPATCH currently is in late-stage clinical trials, with potential FDA approval expected within 12-36 months. Regulatory approval will depend on demonstrated efficacy and safety, with accelerated pathways potentially available for breakthrough indications.

Approval opens access to a market estimated at USD 10-12 billion for similar drug classes in the U.S. alone. It enables commercialization, licensing, or partnership deals, impacting revenue streams.

What are the revenue projections for FEMPATCH?

Revenue estimates for FEMPATCH are subject to several assumptions regarding market penetration, pricing, and competition:

Scenario	Market Penetration	Average Price (USD)	Projected Year 5 Revenue
Conservative	10% of eligible	5,000	USD 500 million
Moderate	25% of eligible	5,000	USD 1.25 billion
Aggressive	40% of eligible	5,000	USD 2 billion

Eligible patient pool includes postmenopausal women with hormone receptor-positive (HR+), HER2-negative breast cancer, estimated at 2 million globally.

Pricing assumptions align with current SERM therapies, with potential premium if FEMPATCH offers superior safety or efficacy.

What factors influence FEMPATCH’s market share growth?

Market share expansion hinges on several factors:

• Clinical efficacy and safety: Demonstrating clear advantages over existing therapies influences prescribing habits.
• Regulatory approval: Fast-track options improve time-to-market.
• Reimbursement policies: Positive payer decisions reduce patient out-of-pocket costs.
• Competitive landscape: Entry of new competitors or biosimilars can restrict market growth.
• Physician and patient acceptance: Education and awareness campaigns shape adoption.

How do patent and patent expirations affect FEMPATCH’s financial trajectory?

Patent exclusivity typically lasts 7-12 years from approval, depending on jurisdiction. The initial 5-year data exclusivity provides early market protection. Expiry opens opportunities for biosimilars or generics, which can rapidly erode sales.

Strategies such as patent extensions through method of use patents, formulation patents, or combination therapies can extend market exclusivity.

What are the key risks and uncertainties?

• Regulatory delays or rejections.
• Clinical trial failures.
• Pricing and reimbursement constraints.
• Market competition.
• Post-marketing safety concerns.

Summary of financial trajectory timeline:

Year	Milestone	Expected Impact
Year 1	Completion of Phase 3 trials	Prepare NDA submission, start market planning
Year 2	Regulatory submission and review	Potential approval, limited revenue (if approved early)
Year 3	Early commercialization in key markets	Establish brand presence, begin revenue stream
Year 4	Market expansion, reimbursement agreements	Increase sales volume
Year 5	Peak sales, patent protection in force	Achieve projected revenue targets (USD 1-2 billion)

Key Takeaways

• FEMPATCH operates in a growing breast cancer segment with increasing global incidence.
• Market entry depends heavily on successful regulatory approval and competitive positioning.
• Revenue projections range from USD 500 million to USD 2 billion within five years post-launch.
• Market share expansion depends on clinical benefits over existing therapies, payer acceptance, and physician adoption.
• Patent life and patent strategy significantly influence long-term revenue potential.

FAQs

1. When is FEMPATCH expected to launch commercially?
Likely 24-36 months after regulatory submission, contingent on clinical trial results and approval timeline.

2. How does FEMPATCH compare to existing hormone therapies?
It is designed to offer improved efficacy, safety, or convenience, though data are pending.

3. What markets present the largest revenue opportunities for FEMPATCH?
The U.S., EU countries, and China drive the largest revenues due to high breast cancer rates and healthcare spending.

4. How can patent strategies extend FEMPATCH’s market exclusivity?
Through method-of-use patents, formulation patents, and combination patents.

5. What are the main risks for FEMPATCH’s market success?
Regulatory setbacks, clinical trial failures, pricing challenges, and intense competition.

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Sources:

[1] GLOBOCAN, International Agency for Research on Cancer, 2020.
[2] IQVIA, Global Oncology Market Report, 2022.
[3] U.S. Food and Drug Administration, Drug Approval Process.