ESCLIM Drug Patent Profile

When do Esclim patents expire, and when can generic versions of Esclim launch?

Esclim is a drug marketed by Women First Hlthcare and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Esclim

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

Summary for ESCLIM

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	109
Patent Applications:	4,086
DailyMed Link:	ESCLIM at DailyMed

US Patents and Regulatory Information for ESCLIM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Women First Hlthcare	ESCLIM	estradiol	SYSTEM;TRANSDERMAL	020847-001	Aug 4, 1998		DISCN	No	No
Women First Hlthcare	ESCLIM	estradiol	SYSTEM;TRANSDERMAL	020847-004	Aug 4, 1998		DISCN	No	No
Women First Hlthcare	ESCLIM	estradiol	SYSTEM;TRANSDERMAL	020847-002	Aug 4, 1998		DISCN	No	No
Women First Hlthcare	ESCLIM	estradiol	SYSTEM;TRANSDERMAL	020847-003	Aug 4, 1998		DISCN	No	No
Women First Hlthcare	ESCLIM	estradiol	SYSTEM;TRANSDERMAL	020847-005	Aug 4, 1998		DISCN	No	No

Expired US Patents for ESCLIM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Women First Hlthcare	ESCLIM	estradiol	SYSTEM;TRANSDERMAL	020847-005	Aug 4, 1998
Women First Hlthcare	ESCLIM	estradiol	SYSTEM;TRANSDERMAL	020847-001	Aug 4, 1998
Women First Hlthcare	ESCLIM	estradiol	SYSTEM;TRANSDERMAL	020847-004	Aug 4, 1998
Women First Hlthcare	ESCLIM	estradiol	SYSTEM;TRANSDERMAL	020847-003	Aug 4, 1998
Women First Hlthcare	ESCLIM	estradiol	SYSTEM;TRANSDERMAL	020847-002	Aug 4, 1998

International Patents for ESCLIM

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

Country	Patent Number	Title	Estimated Expiration
Spain	2027773
Austria	69724
Greece	3003887
Japan	S63255217	ADHESIVE MATRIX FOR TRANSDERMAL ADMINISTRATION OF ACTIVE COMPONENT AND MANUFACTURE
European Patent Office	0288336	SELF-STICKING DEVICE FOR THE TRANSDERMAL ADMINISTRATION OF AN ACTIVE AGENT
France	2612785
Japan	H0780758

Supplementary Protection Certificates for ESCLIM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0770388	PA2009004,C0770388	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
0584952	99C0004	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0770388	09C0018	France		PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103

ESCLIM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ESCLIM and the Hormonal Replacement Therapy Market

Introduction

ESCLIM, an estradiol transdermal system, is a key player in the hormonal replacement therapy (HRT) market, particularly for treating menopausal symptoms. To understand the market dynamics and financial trajectory of ESCLIM, it is essential to delve into the broader HRT market and its trends.

Market Size and Growth

The global drugs for hormonal replacement therapy market has been experiencing robust growth. In 2023, the market size was valued at $12.99 billion and is projected to grow to $13.77 billion in 2024 at a compound annual growth rate (CAGR) of 6.0%. By 2028, the market is expected to reach $16.82 billion, driven by factors such as the rising incidence of hormonal disorders, increasing health consciousness, and advancements in healthcare infrastructure[1].

Drivers of the Market

Several factors are driving the growth of the HRT market, including:

Aging Population

The increasing age of the global population is a significant driver, as older individuals are more likely to suffer from hormonal imbalances and related disorders[1].

Increasing Awareness and Lifestyle Factors

Greater awareness about menopausal symptoms and lifestyle changes have led to more women seeking HRT, contributing to market growth[1].

Regulatory Approvals

Recent regulatory approvals for new HRT drugs and delivery methods have expanded treatment options, attracting more patients to the market[1].

Healthcare Expenditures

Rising healthcare expenditures, particularly in regions like the United States, have increased access to HRT treatments. For instance, healthcare spending in the U.S. increased to $4.3 trillion in 2021, supporting the development and accessibility of HRT drugs[1].

Segmentation of the HRT Market

The HRT market is segmented by therapy type and distribution channels.

Therapy Type

• Estrogen Replacement Therapy: This is a significant segment, with drugs like ESCLIM being widely used to treat menopausal symptoms.
• Human Growth Hormone (HGH) Replacement Therapy
• Thyroid Replacement Therapy
• Testosterone Replacement Therapy

Each of these segments has its own growth trajectory and market dynamics[1].

Distribution Channels

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

The distribution channels play a crucial role in the accessibility and affordability of HRT drugs like ESCLIM[1].

Financial Trajectory of ESCLIM

Given that ESCLIM is part of the broader estrogen replacement therapy segment, its financial trajectory is closely tied to the overall market trends.

Revenue Contribution

ESCLIM, along with other estradiol transdermal systems like Vivelle and Estraderm, contributes significantly to the revenue of the estrogen replacement therapy segment. The market for these drugs is expected to continue growing as more women seek treatment for menopausal symptoms[1].

Cost and Pricing

The cost of ESCLIM and similar drugs can be influenced by several factors, including competition, regulatory environments, and healthcare expenditures. For instance, the average cost of biological products, which include some HRT drugs, has increased significantly, with a 54.6% increase in expenditures from 2017 to 2022[3].

Competitive Landscape

The HRT market is competitive, with multiple manufacturers offering various forms of estrogen replacement therapy. The competitive landscape is further complicated by the presence of generic and branded drugs, each with its own pricing dynamics. For example, the ASPE report highlights that drugs with fewer manufacturers tend to have higher prices, which could impact the pricing strategy for ESCLIM[3].

Technological Advancements and Delivery Methods

Technological advancements in delivery methods are a key trend in the HRT market. Transdermal systems like ESCLIM offer advantages such as lower circulating concentrations of estrone and estrone conjugates and require smaller total doses compared to oral therapy. These advancements can drive patient preference and adherence, contributing to the financial success of such products[4].

Regional Market Dynamics

The HRT market varies significantly by region. North America was the largest region in 2023, while the Middle East is expected to be the fastest-growing region during the forecast period. Understanding regional market dynamics is crucial for manufacturers to tailor their strategies and distribution channels effectively[1].

Challenges and Opportunities

High-Cost Therapies

The management of high-cost therapies, including some HRT drugs, poses challenges for healthcare systems. Factors such as the cost of goods, service delivery costs, and reimbursement strategies need to be carefully evaluated. Health systems are increasingly engaging in value-based contracting and collaborating with finance and revenue cycle teams to manage these costs effectively[2].

Patient Education and Empowerment

Patient education and empowerment are critical for the growth of the HRT market. As patients become more informed about their treatment options, they are more likely to seek out therapies like ESCLIM, driving market growth[1].

Key Takeaways

• Market Growth: The HRT market is expected to grow significantly, driven by an aging population, increasing awareness, and advancements in healthcare.
• Segmentation: The market is segmented by therapy type and distribution channels, with estrogen replacement therapy being a key segment.
• Financial Trajectory: ESCLIM’s financial trajectory is tied to the overall market trends, with revenue contributions expected to grow as more women seek HRT.
• Technological Advancements: Advancements in delivery methods, such as transdermal systems, are driving patient preference and adherence.
• Regional Dynamics: Understanding regional market dynamics is crucial for effective strategy and distribution.

FAQs

1. What is the projected growth rate of the HRT market?

   • The HRT market is expected to grow at a CAGR of 5.1% from 2023 to 2028[1].

2. What are the main drivers of the HRT market?

   • The main drivers include an aging population, increasing awareness, lifestyle factors, regulatory approvals, and rising healthcare expenditures[1].

3. How does ESCLIM compare to other estrogen replacement therapies?

   • ESCLIM offers advantages such as lower circulating concentrations of estrone and estrone conjugates and requires smaller total doses compared to oral therapy[4].

4. What are the challenges in managing high-cost HRT therapies?

   • Challenges include evaluating the cost of goods, service delivery costs, and reimbursement strategies. Health systems are adopting value-based contracting and collaborative approaches to manage these costs[2].

5. Which region is expected to be the fastest-growing in the HRT market?

   • The Middle East is expected to be the fastest-growing region during the forecast period[1].

Sources

1. The Business Research Company - Drugs For Hormonal Replacement Therapy Global Market Report
2. ASHP - Strategic Directions in System Formulary, Drug Policy, and High-Cost Drugs
3. ASPE - Competition in Prescription Drug Markets, 2017-2022
4. FDA - NDA 20,847 (ESCLIM® estradiol transdermal system)