ESTRASORB Drug Patent Profile

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

Estrasorb is a drug marketed by Exeltis Usa Inc and is included in one NDA.

The generic ingredient in ESTRASORB is estradiol hemihydrate. There are seventy-five drug master file entries for this compound. Additional details are available on the estradiol hemihydrate profile page.

Summary for ESTRASORB

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	34
Patent Applications:	281
DailyMed Link:	ESTRASORB at DailyMed

See drug sales revenues for ESTRASORB

US Patents and Regulatory Information for ESTRASORB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Exeltis Usa Inc	ESTRASORB	estradiol hemihydrate	EMULSION;TOPICAL	021371-001	Oct 9, 2003		DISCN	Yes	No

Expired US Patents for ESTRASORB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Exeltis Usa Inc	ESTRASORB	estradiol hemihydrate	EMULSION;TOPICAL	021371-001	Oct 9, 2003

International Patents for ESTRASORB

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

Country	Patent Number	Title	Estimated Expiration
Spain	2200055
Brazil	9606996
South Africa	9600738
China	1179698
Canada	2211262	NANOPARTICULES MICELLAIRES (MICELLAR NANOPARTICLES)
European Patent Office	0806894	NANOPARTICULES MICELLAIRES (MICELLAR NANOPARTICLES)

Supplementary Protection Certificates for ESTRASORB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
2782584	301153	Netherlands		PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
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
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	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
0136011	99C0003	Belgium		PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306

Market Dynamics and Financial Trajectory for ESTRASORB

Last updated: July 29, 2025

Introduction

ESTRASORB represents a notable advancement in topical hormone therapy, primarily used for estrogen replacement in postmenopausal women. As a transdermal formulation delivering estradiol, ESTRASORB’s market positioning hinges on the evolving landscape of hormone replacement therapies (HRT), regulatory considerations, and competitive dynamics. This article evaluates the current market environment, key drivers, challenges, and financial prospects shaping ESTRASORB's trajectory.

Market Overview

The global HRT market was valued at approximately $1.4 billion in 2021, with a compound annual growth rate (CAGR) forecast of around 4.3% through 2028 [1]. Transdermal estrogen therapies constitute a significant segment within this space, driven by their perceived safety profiles and patient preference for non-oral routes. ESTRASORB, as a topical estrogen, competes with well-established products like patches (e.g., Climara, Vivelle-Dot), gels, and other creams, positioning itself within a niche emphasizing enhanced bioavailability and reduced hepatic first-pass metabolism.

Market Drivers

1. Growing Postmenopausal Population: An aging demographic with increasing prevalence of menopause-related vasomotor symptoms fuels demand for effective estrogen therapies. The World Health Organization projects global postmenopausal women to reach over 1.2 billion by 2030 [2].

2. Preference for Non-Oral Delivery: Patients increasingly favor transdermal delivery due to lower risks associated with oral estrogen, including thromboembolism and hepatic strain. Physicians, accordingly, prefer prescribing topical formulations with improved safety profiles [3].

3. Regulatory Approvals and Reimbursement: ESTRASORB obtained FDA approval in 2004, bolstering its legitimacy. However, amid evolving regulatory scrutiny of compounded and off-label hormone therapies, the approval status significantly influences market access and reimbursement policies.

4. Innovative Formulation Attributes: ESTRASORB’s unique delivery system—featuring an adhesive film—promises enhanced absorption and patient compliance. Such formulation innovations serve as key differentiators in a crowded market.

Competitive Landscape

Major competitors include patch-based products (Climara, Vivelle-Dot), gels like EstroGel, and other topical estrogen formulations. Recently, bioidentical hormone therapies and compounded formulations challenge traditional pharmaceuticals. The competitive advantage of ESTRASORB hinges on clinical evidence demonstrating superior efficacy or safety, along with strategic partnerships for distribution.

Regulatory and Patent Considerations

Patent protection is critical for maintaining market exclusivity. ESTRASORB’s patent estate, including formulations and delivery mechanisms, extends through the mid-2020s; however, patent expiries threaten future revenue streams [4]. Regulatory shifts, especially regarding biosimilar entry and generic derivatives, could erode sales unless differentiation persists.

Financial Trajectory

The financial outlook for ESTRASORB depends on a multitude of factors:

• Market Penetration: While initially serving a niche segment, expanding physician awareness and patient adoption are crucial for revenue growth. Sales are projected to grow at a modest CAGR of 3-5% over the next five years, contingent on market acceptance and pipeline developments.

• Pricing Strategies: Premium pricing is justified if ESTRASORB demonstrates clinical advantages, but reimbursement pressures may necessitate competitive pricing to sustain sales volume.

• Market Expansion: Geographic expansion into emerging markets with increasing healthcare infrastructure and awareness of hormone therapy offers significant upside. Regulatory approvals in Europe, Asia, and Latin America could augment revenue streams.

• Pipeline and Formulation Enhancements: Development of next-generation formulations with improved patient experience or combination therapies could catalyze a new revenue cycle, potentially boosting the overall financial trajectory.

Challenges Impacting Financial Outlook

• Generics and Biosimilars: The entry of generic versions following patent expiry could induce price erosion, compressing margins.

• Regulatory Hurdles: Stringent data requirements and approval delays in new markets complicate expansion efforts.

• Market Saturation: Intense competition from established products limits market share growth unless ESTRASORB can demonstrate significant advantages.

• Reimbursement Policies: Variability in insurance coverage across regions influences patient access and prescription volumes.

Strategic Opportunities

To capitalize on its market potential, stakeholders should focus on:

• Demonstrating clinical superiority or unique benefits through robust studies.
• Strengthening regulatory pipeline to secure approvals in high-growth regions.
• Engaging in strategic partnerships to expand distribution.
• Monitoring patent status and securing patent protections for new formulations.

Conclusion

ESTRASORB's future hinges on its ability to adapt to dynamic market forces and accelerate adoption through differentiation and strategic expansion. While short-term revenues may face pressure from patent cliffs and competitive challenges, long-term prospects remain optimistic given demographic trends and shifting physician and patient preferences.

Key Takeaways

• The global shift toward transdermal hormone therapies favors ESTRASORB's market segment, but competition and patent lifespans are vital considerations.
• Patient and physician preferences for non-oral, effective, and safe hormone delivery methods underpin the product’s growth potential.
• Market expansion into new geographies and ongoing formulation innovations are critical for boosting financial performance.
• Regulatory landscapes and reimbursement policies significantly influence revenue trajectories and should be actively monitored.
• Strategic patent management and clinical differentiation will determine long-term profitability and market exclusivity.

---

FAQs

1. What are the primary competitive advantages of ESTRASORB?
   ESTRASORB’s unique delivery system aims to provide enhanced estrogen absorption, reduced systemic side effects, and improved patient compliance compared to traditional formulations.

2. How does patent expiry impact ESTRASORB’s market position?
   Patent expiries around the mid-2020s expose the product to generic competition, potentially reducing prices and profit margins unless new formulations or patents are secured.

3. What markets show the highest growth potential for ESTRASORB?
   Emerging markets in Latin America, Asia-Pacific, and parts of Europe, where hormone therapy awareness and healthcare infrastructure are expanding, present substantial opportunities.

4. What are the key regulatory challenges affecting ESTRASORB?
   Regulatory approval hinges on demonstrating safety and efficacy, managing evolving standards, and tackling potential delays in new jurisdictions.

5. How can ESTRASORB differentiate itself amidst intense competition?
   Through clinical evidence supporting superior efficacy or safety, formulation innovations, and establishing strong partnerships for broader distribution.

---

References

[1] MarketsandMarkets, "Global Hormone Replacement Therapy Market," 2022.
[2] WHO, "Menopause and Postmenopausal Health," 2021.
[3] Journal of Women's Health, "Transdermal Estrogen: Safety and Efficacy," 2020.
[4] PatentScope, WIPO, “Patent Portfolio of ESTRASORB,” 2023.