ELACESTRANT HYDROCHLORIDE - Generic Drug Details

What are the generic sources for elacestrant hydrochloride and what is the scope of freedom to operate?

Elacestrant hydrochloride is the generic ingredient in one branded drug marketed by Stemline Therap and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Elacestrant hydrochloride has one hundred and forty-eight patent family members in twenty-nine countries.

One supplier is listed for this compound.

Summary for ELACESTRANT HYDROCHLORIDE

International Patents:	148
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	29
Patent Applications:	95
DailyMed Link:	ELACESTRANT HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ELACESTRANT HYDROCHLORIDE

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

Sponsor	Phase
Sarah Sammons, MD	PHASE1
Translational Breast Cancer Research Consortium	PHASE2
Kristina A. Fanucci	PHASE2

See all ELACESTRANT HYDROCHLORIDE clinical trials

Pharmacology for ELACESTRANT HYDROCHLORIDE

Drug Class	Estrogen Receptor Antagonist
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Estrogen Receptor Antagonists P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ELACESTRANT HYDROCHLORIDE

L02BA	Anti-estrogens
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for ELACESTRANT HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Stemline Therap	ORSERDU	elacestrant hydrochloride	TABLET;ORAL	217639-001	Jan 27, 2023		RX	Yes	No			Y	Y
Stemline Therap	ORSERDU	elacestrant hydrochloride	TABLET;ORAL	217639-001	Jan 27, 2023		RX	Yes	No
Stemline Therap	ORSERDU	elacestrant hydrochloride	TABLET;ORAL	217639-001	Jan 27, 2023		RX	Yes	No
Stemline Therap	ORSERDU	elacestrant hydrochloride	TABLET;ORAL	217639-001	Jan 27, 2023		RX	Yes	No			Y	Y
Stemline Therap	ORSERDU	elacestrant hydrochloride	TABLET;ORAL	217639-002	Jan 27, 2023		RX	Yes	Yes
Stemline Therap	ORSERDU	elacestrant hydrochloride	TABLET;ORAL	217639-002	Jan 27, 2023		RX	Yes	Yes			Y	Y
Stemline Therap	ORSERDU	elacestrant hydrochloride	TABLET;ORAL	217639-002	Jan 27, 2023		RX	Yes	Yes

International Patents for ELACESTRANT HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Israel	292245	צורות פולימורפיות של rad1901-2hcl (Polymorphic forms of rad1901-2hcl)
Lithuania	3122426
World Intellectual Property Organization (WIPO)	2016176664
Japan	2022172039
Mexico	2022007801
European Patent Office	3122426	MÉTHODE DE TRAITEMENT DU CANCER FAISANT INTERVENIR DES MODULATEURS SÉLECTIFS DES RÉCEPTEURS DES OESTROGÈNES (METHOD OF TREATING CANCER USING SELECTIVE ESTROGEN RECEPTOR MODULATORS)
New Zealand	737822

Supplementary Protection Certificates for ELACESTRANT HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3122426	122024000013	Germany		PRODUCT NAME: ELACESTRANT ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1757 20230915
3122426	2024C/505	Belgium		PRODUCT NAME: ELACESTRANT OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1757 20230918
3122426	C202430006	Spain		PRODUCT NAME: ELACESTRANT, OPCIONALMENTE EN FORMA DE DIHIDROCLORURO DE ELACESTRANT.; NATIONAL AUTHORISATION NUMBER: EU/1/23/1757; DATE OF AUTHORISATION: 20230915; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1757; DATE OF FIRST AUTHORISATION IN EEA: 20230915
3122426	301263	Netherlands		PRODUCT NAME: ELACESTRANT, DESGEWENST IN DE VORM VAN ELACESTRANTDIHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/23/1757 20230918
3122426	CA 2024 00007	Denmark		PRODUCT NAME: ELACESTRANT OR A SALT THEREOF; REG. NO/DATE: EU/1/23/1757 20230918
3122426	LUC00331	Luxembourg		PRODUCT NAME: ELACESTRANT OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1757 20230918
3122426	C20240005	Finland

Market Dynamics and Financial Trajectory for Elacestrant Hydrochloride

Last updated: July 30, 2025

Introduction

Elacestrant hydrochloride, marketed under the proprietary name Orserdu, is a novel selective estrogen receptor degrader (SERD) approved by the U.S. Food and Drug Administration (FDA) in 2023 for use in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced or metastatic breast cancer. As a targeted therapy, elacestrant represents a significant advancement in endocrine resistance management, capitalizing on a growing and lucrative segment of the oncology market. This analysis explores the current market landscape, drivers shaping its financial trajectory, competitive positioning, and future outlook.

Market Landscape and Demand Drivers

Growing Incidence of HR+ Breast Cancer

Breast cancer remains the most diagnosed cancer worldwide, accounting for approximately 12% of all cancers, with HR+ subtypes constituting nearly 70% of cases (globally, approximately 1.8 million new cases annually [1]). The rising prevalence due to aging populations, better detection, and increased awareness propels demand for effective endocrine therapies, including SERDs like elacestrant.

Unmet Needs in Endocrine Resistance

While selective estrogen receptor modulators (SERMs) and aromatase inhibitors have historically been mainstays, resistance development diminishes their efficacy over time. Extending progression-free survival and delaying chemotherapy have become primary treatment goals. Elacestrant's mechanism as a targeted, oral SERD offering improved efficacy against resistant tumors fills critical therapeutic gaps.

Regulatory and Clinical Adoption

The FDA approval in early 2023, based on the EMERALD phase 3 trial demonstrating significant progression-free survival benefits, spurred early adoption among oncologists. Insurance coverage and inclusion in NCCN guidelines further cement its market penetration early stages, with more clinicians embracing the novel oral regimen.

Competitive Landscape

Existing SERDs and Endocrine Therapies

Despite the advent of elacestrant, several competitors persist. Fulvestrant (Faslodex), administered via intramuscular injections, remains a standard second-line therapy. Investigational oral SERDs like amcenestrant, amelastrant, and camizestrant are advancing through trials, intensifying rivalry (though many are still emergent). The novelty and oral administration of elacestrant differentiate it from traditional SERDs, potentially expanding market share.

Other Targeted Therapies

CDK4/6 inhibitors (e.g., palbociclib, ribociclib) combined with endocrine therapy have become standard, and their efficacy may influence elacestrant’s market penetration by either complementing or competing with monotherapy.

Market Dynamics and Growth Opportunities

Market Penetration and Geographic Expansion

The initial launch in the U.S. sets the stage; subsequent approvals hinge on ongoing phase 3 trials and regulatory submissions elsewhere (EU, Asia). As the prevalence of HR+ breast cancer surges in emerging markets, geographic expansion presents substantial revenue opportunities.

Pricing and Reimbursement Strategies

Pricing strategies hinge on comparative efficacy, convenience, and healthcare system reimbursements. While initial pricing is expected to reflect the premium for innovation, widespread insurance coverage will be pivotal for volume-based growth.

Pipeline and Combination Therapies

Ongoing clinical trials assessing elacestrant in combination with CDK4/6 inhibitors, PI3K inhibitors, or PD-1/PD-L1 checkpoint inhibitors aim to broaden indications and enhance efficacy, potentially expanding total addressable market (TAM).

Financial Trajectory and Outlook

Revenue Projections

As of 2023, sales are projected in the hundreds of millions USD, with analyst estimates anticipating a compound annual growth rate (CAGR) of 20-30% over the next five years, driven by increased adoption, expanded indications, and global licensing deals.

Cost Structure and R&D Investment

Initial marketing and sales efforts, coupled with ongoing R&D for combination regimens, will influence profitability. The patent exclusivity period (potentially till 2033+), combined with exclusivity on the specific chemical composition, supports revenue growth in the medium term.

Strategic Partnerships

Partnerships with global pharmaceutical companies for manufacturing, distribution, and clinical development are critical. Licensing agreements could accelerate market access in Asia and Europe, significantly impacting financial growth.

Regulatory and Patent Considerations

Patent protection, granted initially for the compound and later for formulations, safeguards market exclusivity. Potential patent challenges or biosimilar/integrated competition could impact long-term revenue streams.

Risks and Challenges

• Competitive Innovation: Emergence of next-generation SERDs or novel oral endocrine therapies.
• Market Penetration Barriers: Prescriber familiarity with existing therapies and reimbursement hurdles.
• Clinical Efficacy Limitations: Variability in patient response and resistance mechanisms.

Conclusion

Elacestrant hydrochloride is positioned within a burgeoning market segment characterized by high unmet clinical needs and significant growth potential. Its successful commercialization hinges on deeper clinical utility demonstration, strategic market expansion, and navigating competitive landscapes. The next 3-5 years will be pivotal in defining its economic impact as a frontline therapy against endocrine-resistant HR+ breast cancer.

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Key Takeaways

• Elacestrant hydrochloride's approval fills a critical gap in treating endocrine-resistant HR+ breast cancer, positioning it for rapid uptake.
• The global breast cancer market’s growth, coupled with an aging population, underpins sustained demand.
• Competitive strategies—including pricing, pipeline expansion, and global licensing—are essential for maximizing revenue.
• Ongoing clinical trials exploring combination therapies could further expand its indications and market share.
• Regulatory, patent, and reimbursement landscapes will significantly influence its long-term financial trajectory.

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FAQs

1. What distinguishes elacestrant hydrochloride from existing endocrine therapies?
Elacestrant is an oral, selective estrogen receptor degrader (SERD), offering a more convenient administration than intramuscular fulvestrant, with demonstrated efficacy in overcoming endocrine resistance, a common challenge in HR+ breast cancer.

2. What is the current market size for elacestrant?
Initially, the market is targeted at approximately $1 billion in the U.S., with potential global revenues reaching several billion dollars over the next decade, contingent upon approval and adoption rates.

3. How are competitors influencing elacestrant’s market prospects?
Existing therapies like fulvestrant and emerging oral SERDs aim to compete for the same patient population. Elacestrant's differentiators—oral administration and proven efficacy—are critical for capturing market share amidst these rivals.

4. What are the key growth drivers for elacestrant’s financial prospects?
Main drivers include expanding indications, geographic expansion, combination therapy opportunities, and favorable reimbursement policies that enhance patient access.

5. What risks could impact elacestrant’s market success?
Risks involve clinical trial setbacks, competitive innovation, patent challenges, or unfavorable reimbursement policies, all of which could impede market penetration and revenue growth.

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References

1. World Health Organization. Global Cancer Statistics 2022.
2. American Cancer Society. Breast Cancer Facts & Figures 2022-2023.
3. U.S. Food and Drug Administration. FDA Approves Elacestrant for HR+ Breast Cancer.
4. ClinicalTrials.gov. EMERALD Study Data.
5. MarketWatch. Global Oncology Market Forecasts.