ESTRING Drug Patent Profile

Which patents cover Estring, and when can generic versions of Estring launch?

Estring is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in ESTRING 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 Estring

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

Summary for ESTRING

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	4
Patent Applications:	3,885
Drug Prices:	Drug price information for ESTRING
Drug Sales Revenues:	Drug sales revenues for ESTRING
What excipients (inactive ingredients) are in ESTRING?	ESTRING excipients list
DailyMed Link:	ESTRING at DailyMed

See drug prices for ESTRING

See drug sales revenues for ESTRING

Recent Clinical Trials for ESTRING

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Boston Urogynecology Associates	Phase 4
Mount Auburn Hospital	Phase 4
Beth Israel Deaconess Medical Center	Phase 4

See all ESTRING clinical trials

Pharmacology for ESTRING

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for ESTRING

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	ESTRING	estradiol	INSERT, EXTENDED RELEASE;VAGINAL	020472-001	Apr 26, 1996		RX	Yes	Yes

Expired US Patents for ESTRING

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ESTRING	estradiol	INSERT, EXTENDED RELEASE;VAGINAL	020472-001	Apr 26, 1996	4,871,543
Pfizer	ESTRING	estradiol	INSERT, EXTENDED RELEASE;VAGINAL	020472-001	Apr 26, 1996	5,188,835

International Patents for ESTRING

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

Country	Patent Number	Title	Estimated Expiration
Spain	2026481
Finland	91709
Japan	2671953
European Patent Office	0253109	INTRAVAGINAL DEVICE AND METHOD OF PREPARING THE SAME
South Korea	920005824

Supplementary Protection Certificates for ESTRING

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
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

Market Dynamics and Financial Trajectory for ESTRING: An In-Depth Analysis

Last updated: July 29, 2025

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Introduction

ESTRING (estradiol vaginal ring) has established itself as a significant player in the hormone therapy (HT) segment, primarily targeting menopausal women experiencing estrogen deficiency symptoms. As a transdermal delivery system, ESTRING offers a convenient, localized hormone replacement option that balances efficacy with a favorable safety profile, shaping its standing within healthcare markets worldwide. Understanding its market dynamics and projecting its financial trajectory is essential for industry stakeholders aiming to capitalize on current trends and anticipate future shifts.

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Market Overview

Hormone Replacement Therapy Landscape

Hormone Replacement Therapy remains a cornerstone for managing menopausal symptoms, with an estimated global market value surpassing US$3 billion in 2022, projected to expand at a CAGR of approximately 4-6% through 2030 [1]. The increasing aging female population, rising awareness of menopause-related health issues, and advances in hormone delivery systems propel market growth.

ESTRING’s Niche Position

Featuring a unique vaginal ring delivery system, ESTRING provides targeted estradiol supplementation, reducing systemic steroid exposure and associated risks such as breast cancer and thromboembolic events—which are prevalent with oral therapies [2]. Its localized approach has earned regulatory approval in multiple territories, including the US, EU, and Asia, reinforcing its global footprint.

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Market Dynamics Influencing ESTRING

Demand Drivers

• Aging Female Population: Globally, women aged 50 and above are expanding rapidly, especially in North America, Europe, and Asia. This demographic shift fuels demand for menopause management solutions, including estradiol therapies [3].

• Preference for Localized Therapy: Increasing awareness of the safety and convenience of vaginal delivery systems boosts acceptance. Patients seek alternatives to oral formulations, motivated by gastrointestinal tolerability concerns and hepatic first-pass metabolism issues [4].

• Advances in Formulation Technology: Innovations that enhance drug release profiles, minimize side effects, and improve ease of use sustain ESTRING's relevance. Regulatory approval for generic versions further enhances access.

Market Barriers

• Competition from Oral and Transdermal Alternatives: Oral estradiol, patches, gels, and newer delivery systems like implants or injectables offer similar therapeutic benefits, often at lower costs or with higher convenience.

• Regulatory and Reimbursement Challenges: Variations in approval pathways and coverage policies across regions influence market penetration. For example, some national formularies favor oral formulations due to established cost-effectiveness.

• Patient Preference and Awareness: Despite benefits, some women favor pills over vaginal devices due to familiarity, requiring targeted education initiatives.

Competitive Landscape

The ESTRING market faces competition from brands like Femring (estradiol acetate vaginal ring) and generic estradiol products. Notably, the emergence of biosimilars and patent expirations of key brands intensify price pressures, compelling manufacturers to innovate and differentiate.

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Financial Trajectory and Market Forecast

Revenue Streams and Growth Horizons

The downstream revenue for ESTRING hinges on several factors:

• Market Penetration: Tiered strategy across developed and emerging markets, leveraging both brand and generic channels.

• Pricing Strategies: Premium pricing in developed regions versus competitive pricing in emerging economies.

• Innovation and Line Extensions: Introducing formulations with adjunctive progestins, extending indications (e.g., vulvar/vaginal atrophy), and developing user-friendly devices can expand revenue.

Projections (2023-2030)

Analysts estimate that ESTRING’s global revenue could grow from approximately US$200 million in 2022 to over US$400 million by 2030, driven by an CAGR of 7-8%. Key contributing regions include North America (~50% of revenues), Europe (~25%), and emerging markets (~25%) [1].

Market Entry and Expansion Strategies

• Geographical Expansion: Targeted entry into countries with burgeoning menopausal populations, such as China and India, through strategic alliances and local manufacturing.

• Regulatory Approvals: Securing approvals for new indications and formulations to boost lifecycle management.

• Partnerships and Licensing: Collaborating with local pharma entities to facilitate market penetration, especially in price-sensitive markets.

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Impact of Patent and Regulatory Developments

Patent protections, especially on delivery mechanisms and formulation techniques, safeguard ESTRING’s market share. However, eventual patent expirations, anticipated around 2025-2028, may open avenues for generics, exerting downward pressure on prices and revenues [5].

Regulatory bodies’ evolving guidelines emphasizing safety monitoring and evidence-based labeling will necessitate ongoing clinical development and post-marketing surveillance, influencing operational costs and timelines.

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Market Trends and Future Outlook

• Personalized Menopause Management: Rising demand for tailored therapy regimens shifts focus toward flexible dosing, combination therapies, and novel delivery systems that cater to individual needs.

• Digital Health Integration: Incorporation of digital adherence tools and patient tracking enhances compliance, potentially expanding ESTRING’s appeal.

• Emerging Markets Growth: Urbanization, increasing healthcare awareness, and expanding insurance coverage accelerate ESTRING adoption in Asia-Pacific and Latin America.

• Regulatory Scrutiny and Safety Profiles: Enhanced safety data and real-world evidence will influence prescribing patterns, favoring formulations with robust safety records like ESTRING.

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Key Challenges and Opportunities

Challenges

• Price competition from generics post-patent expiry.

• Clinician and patient preference shifts toward alternative HT modalities.

• Navigating complex regulatory landscapes across multiple geographies.

Opportunities

• Expanding exclusive indications, such as for vulvar atrophy.

• Developing combination products integrating estrogen with progestins or other agents.

• Leveraging digital health strategies to enhance patient adherence and reporting.

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Conclusion

The ESTRING market presents a compelling blend of growth opportunities driven by demographic shifts, technological innovations, and evolving patient preferences. While face constraints like patent expirations and stiff competition, proactive strategic initiatives—such as geographical expansion, formulation innovation, and alliances—can sustain its revenue trajectory. Its unique mode of delivery secures a niche position, yet adaptability remains key for long-term growth.

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Key Takeaways

• Market Expansion is Critical: Targeting emerging economies and gaining regulatory approval in new regions will propel growth.

• Innovation Drives Longevity: Developing new formulations, indications, and combination options can extend product lifecycle and revenue streams.

• Patents and Competition States: Patent expirations necessitate strategic planning for generics; differentiation via innovation and marketing is essential.

• Patient-Centric Approaches: Emphasizing safety, convenience, and personalized therapy enhances acceptance and adherence.

• Monitoring Regulatory Trends: Staying ahead of evolving standards ensures compliance and smoother market access.

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FAQs

1. How does ESTRING compare with other hormone replacement therapies?
ESTRING offers localized estrogen delivery, minimizing systemic side effects associated with oral therapies. Its ease of use and targeted action appeal to patients seeking non-oral options, though competition from patches, gels, and oral pills remains.

2. What are the main factors influencing ESTRING’s market growth?
Demographic aging, patient preference for non-oral delivery systems, technological advancements, regulatory approvals, and expansion into emerging markets all drive growth.

3. What challenges could impact ESTRING’s market share?
Patent expirations leading to generics, competition from alternative therapies, regulatory hurdles, and shifts in clinical guidelines may reduce ESTRING’s dominance.

4. Are there any recent innovations improving ESTRING’s competitiveness?
Yes. Advances include optimized drug release profiles, combination formulations, and improved delivery mechanisms aiming to enhance safety and adherence.

5. What strategic moves can companies use to maximize ESTRING’s financial potential?
Entering high-growth markets, obtaining new indications, developing line extensions, forming strategic alliances, and investing in digital health tools are key strategies.

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References

[1] Research and Markets. (2022). Global Menopause Market Analysis.
[2] North American Menopause Society. (2021). Menopause and Hormone Therapy.
[3] United Nations Department of Economic and Social Affairs. (2022). World Population Prospects.
[4] Gülpinar, K., & Topçu, T. (2020). Advances in Vaginal Delivery Systems for Hormone Therapy. Journal of Drug Delivery Science and Technology.
[5] U.S. Food and Drug Administration. (2022). Patent Expiration Guidelines.