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:	109
Patent Applications:	5,601
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
Australia	3853089
Germany	3751383
Japan	2535731
Spain	2075966

Supplementary Protection Certificates for FEMPATCH

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
2782584	2021C/558	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211

Market Dynamics and Financial Trajectory of Transdermal Drug Delivery Systems: Focus on FemPatch

Introduction to Transdermal Drug Delivery Systems

Transdermal drug delivery systems, including products like FemPatch, are revolutionizing the way medications are administered. These systems deliver drugs directly through the skin, bypassing the liver's first-pass metabolism, which can reduce the potency of orally administered drugs. This method has become increasingly popular for managing chronic conditions, including hormonal imbalances.

Market Size and Growth

The global transdermal drug delivery systems market was valued at USD 66.20 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 11.9% from 2024 to 2030, reaching USD 145.04 billion by 2030[1].

Focus on Hormone Replacement Therapy (HRT)

Within this broader market, hormone replacement therapy (HRT) products, such as FemPatch, are experiencing significant growth. The estradiol transdermal patches market, for instance, is driven by the increasing demand for treatments addressing menopausal symptoms and other hormonal imbalances. This segment is expected to see substantial growth, with the global estradiol gel market alone projected to grow from USD 79 million in 2023 to USD 127 million by 2030 at a CAGR of 7.3%[2].

Market Segments and Geography

The market for estradiol transdermal patches is segmented by type (e.g., 25 mg/day, 50 mg/day, 75 mg/day, 100 mg/day) and application (male and female). Geographically, North America, Europe, and the Asia-Pacific region are key drivers of market growth. North America, particularly the U.S., dominated the market in 2023 due to its well-developed healthcare infrastructure, technological advancements, and significant investments in research and development[1][3].

Financial Performance

Companies in the estradiol market, including those producing transdermal patches, are experiencing robust financial performance. For example, Fuji Pharma Co., Ltd. reported a record high in consolidated sales partly due to the growth in women's healthcare products, including hormone replacement therapies. Investments in research and development, such as new product approvals and biosimilars, are also driving revenue growth and profitability[2].

Drivers of Market Growth

Several factors are driving the growth of the transdermal drug delivery systems market, including:

Increasing Prevalence of Chronic Diseases

The rising incidence of chronic diseases, such as menopause and diabetes, is fueling the demand for sustained medication delivery methods like transdermal patches[1].

Technological Advancements

Advancements in technology are enabling the development of more efficient and patient-friendly transdermal delivery systems. This includes improvements in patch design, drug formulation, and delivery mechanisms[1].

Government Funding and Reimbursement

Governments worldwide are increasing funding towards healthcare, creating favorable reimbursement scenarios that promote the adoption of transdermal drug delivery systems[1].

Mergers and Acquisitions

The market is seeing significant merger and acquisition activity as companies aim to expand their product portfolios, enhance technological capabilities, and strengthen their market presence[1].

Regulatory Environment

The transdermal drug delivery system market is regulated by bodies such as the FDA in the U.S. and the EMA in Europe. These regulations ensure the safety, efficacy, and quality of transdermal drug delivery systems, setting standards for development, manufacturing, and marketing[1].

Competitive Landscape

The competitive landscape of the transdermal patches market includes several major pharmaceutical companies such as Novartis, Bayer Healthcare Pharmaceuticals, and AbbVie. These companies are engaged in various strategic activities including product launches, partnerships, and mergers and acquisitions to maintain and expand their market share[3].

Challenges and Opportunities

While the market is poised for significant growth, it also faces challenges such as medication failures, recalls of transdermal drug delivery systems, and increasing healthcare facility costs. However, these challenges also present opportunities for innovation and improvement in product design and safety[4].

FemTech and Women's Health

The growth of FemTech, a sector focused on women's health and wellbeing, is closely tied to the market dynamics of transdermal drug delivery systems. FemTech is forecast to become a trillion-dollar sector by 2027, driven by innovations in prevention, detection, self-management, diagnosis, and treatment of women's health issues. Products like FemPatch are part of this broader trend, addressing previously underserved needs and improving care delivery[5].

Key Takeaways

• Market Growth: The transdermal drug delivery systems market, including estradiol transdermal patches, is experiencing rapid growth driven by increasing demand for non-invasive drug delivery methods and the rising prevalence of chronic diseases.
• Financial Performance: Companies in this market are seeing robust revenue growth due to investments in research and development and the expansion of product portfolios.
• Geographical Dominance: North America, particularly the U.S., dominates the market, but the Asia-Pacific region is expected to grow fastest during the forecast period.
• Regulatory Environment: Strict regulations ensure the safety and efficacy of transdermal drug delivery systems.
• Competitive Landscape: The market is highly competitive with major pharmaceutical companies actively involved in strategic activities to maintain market share.

FAQs

What is the projected growth rate of the global transdermal drug delivery systems market?

The global transdermal drug delivery systems market is expected to grow at a CAGR of 11.9% from 2024 to 2030[1].

Which region dominates the transdermal drug delivery systems market?

North America, particularly the U.S., dominated the market in 2023, but the Asia-Pacific region is expected to grow the fastest during the forecast period[1].

What are the key drivers of the estradiol transdermal patches market?

The key drivers include the increasing prevalence of chronic diseases, technological advancements, and favorable reimbursement scenarios[1][2].

How does the regulatory environment impact the transdermal drug delivery systems market?

The regulatory environment, overseen by bodies like the FDA and EMA, ensures the safety, efficacy, and quality of transdermal drug delivery systems, setting standards for development, manufacturing, and marketing[1].

What is the role of FemTech in the growth of transdermal drug delivery systems?

FemTech, focusing on women's health and wellbeing, is driving innovation and growth in products like FemPatch, addressing previously underserved needs and improving care delivery[5].

What challenges does the transdermal drug delivery systems market face?

The market faces challenges such as medication failures, recalls, and increasing healthcare facility costs, but these also present opportunities for innovation and improvement[4].