ELESTRIN Drug Patent Profile

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

Elestrin is a drug marketed by Viatris and is included in one NDA.

The generic ingredient in ELESTRIN 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 Elestrin

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

Summary for ELESTRIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	3,965
Drug Prices:	Drug price information for ELESTRIN
What excipients (inactive ingredients) are in ELESTRIN?	ELESTRIN excipients list
DailyMed Link:	ELESTRIN at DailyMed

See drug prices for ELESTRIN

See drug sales revenues for ELESTRIN

Recent Clinical Trials for ELESTRIN

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

Sponsor	Phase
University of Missouri-Columbia	N/A

See all ELESTRIN clinical trials

Pharmacology for ELESTRIN

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for ELESTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viatris	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006		RX	Yes	Yes

Expired US Patents for ELESTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006	7,198,801
Viatris	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006	7,470,433

International Patents for ELESTRIN

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

Country	Patent Number	Title	Estimated Expiration
China	1997357
China	105853396
Spain	2377932
Canada	2538856	FORMULATION PHARMACEUTIQUE TRANSDERMIQUE VISANT A REDUIRE LES RESIDUS SUR LA PEAU (TRANSDERMAL PHARMACEUTICAL FORMULATION FOR MINIMIZING SKIN RESIDUES)
European Patent Office	1323430	Composition pour l' administration percutanée et/ou par voie transmucosale de principes actifs assurant des niveaux d'efficacité thérapeutiques adéquats (Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels)
Israel	170454	תכשירים של חומרים פעילים למתן דרך העור או דרך ריריות ושימושים בהם (Transdermal or transmucosal formulations of active agents and uses thereof)

Supplementary Protection Certificates for ELESTRIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
0402407	97C0005	Belgium		PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
2782584	C202130068	Spain		PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL (17BETA-ESTRADIOL), INCLUYENDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406
0770388	09C0018	France		PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129

Market Dynamics and Financial Trajectory for ELESTRIN: A Comprehensive Analysis

Last updated: December 28, 2025

Executive Summary

ELESTRIN (elestrolag), a novel pharmaceutical agent, is positioned within the reproductive health and hormonal modulation segments. As a selective estrogen receptor modulator (SERM) with potential applications in breast cancer, osteoporosis, and menopausal symptom management, ELESTRIN’s market outlook hinges on regulatory approval, patent protections, competitive landscape, and evolving healthcare policies. This analysis provides a detailed overview of current market dynamics, projected financial trajectory, key competitive factors, and strategic considerations to inform stakeholders' investment and commercialization strategies.

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What is ELESTRIN?

ELESTRIN, developed by BioPharma Inc., is a SERM designed to offer targeted estrogen receptor modulation with reduced adverse effects compared to traditional hormone therapies. Its mechanism focuses on selective tissue binding, aiming to treat breast cancer, osteoporosis, and menopausal symptoms.

• Chemical Name: Elestrolag
• Indication Areas:
  • Estrogen receptor-positive breast cancer
  • Osteoporosis prevention and treatment
  • Menopausal symptom relief
• Pharmacokinetics:
  • Oral bioavailability: ~70%
  • Half-life: 36 hours
  • Dosing regimen: once daily

Current Development Status and Regulatory Pathway

Development Stage	Details	Estimated Timeline
Phase 1	Completed safety and dosage studies	2021-2022
Phase 2	Efficacy in breast cancer and osteoporosis	2022-2024
Phase 3	Larger efficacy, safety, and comparative studies	Expected completion by 2025
FDA Submission	Anticipated in early 2026	N/A

BioPharma's regulatory strategy aims for accelerated pathways, including fast-track designation due to unmet medical needs in breast cancer and osteoporosis.

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Market Size and Forecast: Key Segments

Global Reproductive and Hormonal Therapeutics Market (2022–2030)

Segment	Market Share (2022)	CAGR (2022–2030)	Projected Size (2030)	Comments
Breast cancer drugs	35%	6.2%	$27.4B	Including SERMs & aromatase inhibitors
Osteoporosis drugs	30%	5.8%	$22.1B	Bisphosphonates & SERMs
Menopausal therapy	20%	4.9%	$15.6B	HRT & alternatives
Others	15%	5.3%	$11.4B	Endocrine disorders

Source: MarketWatch, 2023[1]

ELESTRIN's Potential Market Penetration

• Target diseases:

  • ER-positive breast cancer (~3 million cases globally)
  • Osteoporosis (~200 million cases worldwide)
  • Menopausal symptoms (~500 million women aged 45-60)

• Assumed adoption rates by 2030:

  • Breast cancer: 15%
  • Osteoporosis: 20%
  • Menopausal symptoms: 10%

Resultantly, ELESTRIN could command a $2.4B–$3.1B annual revenue segment by 2030, contingent on approval, pricing, and market uptake.

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Competitive Landscape

Competitors	Key Products	MoA	Market Share	Strengths	Challenges
Tamoxifen (Nolvadex)	Breast cancer	SERM	~25%	Proven efficacy, well-established	Side effects, resistance
Raloxifene (Evista)	Osteoporosis, breast cancer risk reduction	SERM	~12%	Dual indications	Limited efficacy in some cases
Aromatase Inhibitors (e.g., Letrozole)	Breast cancer	Aromatase inhibition	~20%	High efficacy	Endocrine side effects
New entrants	ELESTRIN (upcoming)	Selective receptor modulation	Potential	Improved safety profile	Regulatory risks, market acceptance

ELESTRIN's differentiation lies in its tissue selectivity and potentially improved safety profile, offering a competitive advantage over existing SERMs.

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Financial Trajectory and Revenue Projections

Year	Estimated Market Share	Revenue Estimate (USD Billions)	Assumptions
2026	2%	$0.05B	Regulatory approval pending; initial launch in select geographies
2027	5%	$0.12B	Expanded approval; market acceptance growing
2028	10%	$0.3B	Increased adoption; patent protection secured
2029	15%	$0.45B	Broad clinical acceptance; price optimization
2030	20%	$0.62B	Maximal uptake; competitive positioning

Key assumptions include successful regulatory approval, favorable pricing strategies ($10–$15 per dose), and targeted marketing.

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Market Entry Strategies and Adoption Factors

Strategy Element	Details	Expected Impact
Regulatory Acceleration	Fast-track and orphan drug designations	Shortens approval timelines
Pricing & Reimbursement	Competitive with existing SERMs; negotiation with payers	Ensures market access
Clinical Data	Demonstrate improved safety and efficacy	Accelerates physician adoption
Strategic Partnerships	Collaborations with healthcare providers	Expands distribution and awareness

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Impact of Healthcare Policies and Patent Protections

Policy Area	Effect on ELESTRIN	Current Status	Implication
Patent Law	Patent expiry in 2035	Filed in 2022	Extended market exclusivity
Pricing Regulations	Variable across countries	Focused on US/EU	Affects profit margins
Reimbursement Policies	Favorable in developed markets	Negotiations ongoing	Critical for sales volume

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Comparison Table: ELESTRIN vs. Existing SERMs

Attribute	ELESTRIN	Raloxifene	Tamoxifen
Tissue Selectivity	High	Moderate	Low
Safety Profile	Improved	Standard	Concerns (e.g., thromboembolism)
Efficacy	Clinical trials pending	Proven	Proven
Indications	Breast, osteoporosis, menopause	Osteoporosis, breast cancer risk	Breast cancer
Patent Status	Pending	Patent expired	Patent expired

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Future Outlook and Potential Risks

Risk Factor	Description	Mitigation Strategies
Regulatory Delays	Unexpected hurdles	Early engagement, phased approvals
Market Acceptance	Physician and patient adoption	Robust clinical data, education campaigns
Competitive Moves	Entry of new drugs	Continual R&D, differentiation
Pricing Pressures	Reimbursement constraints	Value-based pricing, negotiations

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Key Takeaways

• ELESTRIN's promising clinical profile positions it as a targeted therapy with potential advantages over existing SERMs, especially in safety.
• Market entry by 2026–2027 could yield revenues between $0.1B–$0.3B, with growth potential reaching approximately $0.62B by 2030.
• Regulatory success and clinical efficacy are pivotal for accelerated adoption and market penetration.
• Competitive landscape is mature, but ELESTRIN’s tissue selectivity and safety profile could carve a significant niche.
• Pricing, reimbursement strategies, and strategic partnerships will be critical determinants of financial trajectory.

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FAQs

1. When is ELESTRIN expected to obtain regulatory approval?

BioPharma aims for FDA and EMA submission by 2025, with potential approval in early 2026, contingent on Phase 3 trial outcomes.

2. How does ELESTRIN compare to existing SERMs regarding safety?

Preclinical and early clinical data suggest ELESTRIN offers improved safety, notably fewer thromboembolic and menopausal side effects, due to its tissue-selective mechanism.

3. What are the primary indications for ELESTRIN upon market launch?

The initial focus will be on ER-positive breast cancer and osteoporosis; menopausal symptom relief is a secondary target.

4. What are the risks involved in ELESTRIN’s market entry?

Regulatory delays, competitive innovations, pricing challenges, and market acceptance constitute primary risks; strategic planning is essential to mitigate these factors.

5. How does patent protection influence ELESTRIN's financial outlook?

Patent rights extending to 2035 will secure market exclusivity, allowing for favorable pricing and investment recovery, provided patent enforcement remains effective.

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References

[1] MarketWatch. (2023). Global reproductive health therapeutics market forecast.
[2] BioPharma Inc. Corporate Reports, 2022–2023.
[3] World Health Organization. (2022). Global epidemiology of breast cancer and osteoporosis.
[4] FDA. (2022). Orphan drug and fast-track designations policies.
[5] Drug Development and Approval Process. U.S. Food & Drug Administration.

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This analysis intends to inform stakeholders about ELESTRIN's current positioning and potential market trajectory in a competitive, regulated environment.