ELACESTRANT DIHYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for elacestrant dihydrochloride and what is the scope of patent protection?

Elacestrant dihydrochloride 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 dihydrochloride has one hundred and twenty-one patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for ELACESTRANT DIHYDROCHLORIDE

International Patents:	121
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	15
Patent Applications:	37
DailyMed Link:	ELACESTRANT DIHYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ELACESTRANT DIHYDROCHLORIDE

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ELACESTRANT DIHYDROCHLORIDE

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

Sponsor	Phase
QuantumLeap Healthcare Collaborative	Phase 2
Berlin-Chemie AG Menarini Group	Phase 1/Phase 2
Carrick Therapeutics Limited	Phase 1/Phase 2

See all ELACESTRANT DIHYDROCHLORIDE clinical trials

Pharmacology for ELACESTRANT DIHYDROCHLORIDE

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 DIHYDROCHLORIDE

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

US Patents and Regulatory Information for ELACESTRANT DIHYDROCHLORIDE

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 dihydrochloride	TABLET;ORAL	217639-001	Jan 27, 2023		RX	Yes	No	8,399,520		Y	Y
Stemline Therap	ORSERDU	elacestrant dihydrochloride	TABLET;ORAL	217639-002	Jan 27, 2023		RX	Yes	Yes	8,399,520		Y	Y
Stemline Therap	ORSERDU	elacestrant dihydrochloride	TABLET;ORAL	217639-001	Jan 27, 2023		RX	Yes	No	10,420,734
Stemline Therap	ORSERDU	elacestrant dihydrochloride	TABLET;ORAL	217639-002	Jan 27, 2023		RX	Yes	Yes	10,071,066
Stemline Therap	ORSERDU	elacestrant dihydrochloride	TABLET;ORAL	217639-001	Jan 27, 2023		RX	Yes	No	7,612,114		Y	Y

International Patents for ELACESTRANT DIHYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3834824	MÉTHODE DE TRAITEMENT DU CANCER FAISANT INTERVENIR DES MODULATEURS SÉLECTIFS DES RÉCEPTEURS DES STROGÈNES (METHOD OF TREATING CANCER USING SELECTIVE ESTROGEN RECEPTOR MODULATORS)
Slovenia	3565542
Japan	2023052631	癌を治療するための方法
Japan	2018518529	癌を治療するための方法
Israel	267772

Supplementary Protection Certificates for ELACESTRANT DIHYDROCHLORIDE

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	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	PA2024504	Lithuania		PRODUCT NAME: ELACESTRANTAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1757 20230915

ELACESTRANT DIHYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Elacestrant Dihydrochloride

Introduction to Elacestrant Dihydrochloride

Elacestrant, also known as Orserdu, is a selective estrogen receptor degrader (SERD) approved by the FDA for the treatment of ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer in postmenopausal women or adult men who have progressed on at least one line of endocrine therapy[4].

Mechanism of Action and Clinical Efficacy

Elacestrant works by selectively binding to and degrading the estrogen receptor (ER), thereby inhibiting ER-mediated signaling and the growth of ER-positive breast cancer cells. This mechanism is particularly effective in treating cancers with ESR1 mutations, which are often resistant to traditional endocrine therapies[1][4].

Clinical Trials and Approval

The FDA approval of elacestrant was based on the phase 3 EMERALD trial (NCT03778931), which compared elacestrant to the investigator's choice of endocrine therapy (fulvestrant or an aromatase inhibitor) in patients with metastatic breast cancer who had progressed on one or two lines of prior endocrine therapy. The trial demonstrated a statistically significant improvement in progression-free survival (PFS) in patients with ESR1 mutations[4][5].

Market Assessment and Forecast

The market for elacestrant in the treatment of ER-positive, HER2-negative breast cancer is expected to grow, driven by the increasing incidence of breast cancer and the need for effective treatments for advanced and metastatic cases.

• Market Forecast: The market assessment for elacestrant predicts significant growth from 2023 to 2032, driven by its efficacy and the expanding patient population. However, the market will also face competition from other emerging therapies in the ER-positive, HER2-negative breast cancer segment[3].

• Competitive Landscape: Elacestrant will compete with other endocrine therapies such as fulvestrant and aromatase inhibitors. The launch of late-stage emerging therapies in the near future will also impact the market dynamics, making it crucial for manufacturers to differentiate elacestrant through its unique mechanism of action and clinical benefits[3].

Cost-Effectiveness Analysis

A recent cost-effectiveness analysis of elacestrant versus standard of care (SOC) for the second-/third-line treatment of ER-positive, HER2-negative advanced or metastatic breast cancer in the US revealed that elacestrant was not cost-effective.

• Incremental Cost-Effectiveness Ratio (ICER): The analysis showed that elacestrant led to an ICER of $8,672,360 per quality-adjusted life year (QALY) gained compared to SOC, and $2,900,560/QALY gained compared to fulvestrant in the ESR1 mutation subgroup. These values are significantly higher than the willingness-to-pay (WTP) threshold of $150,000/QALY[2].

Regulatory Milestones and Development Activities

Elacestrant has been granted priority review and fast track designation by the FDA, indicating its potential to address an unmet medical need. The drug's approval was facilitated by the Assessment Aid, a voluntary submission from the applicant to support the FDA's assessment[4].

• Companion Diagnostic: The FDA also approved the Guardant360 CDx assay as a companion diagnostic device to identify patients with ESR1 mutations, which is crucial for determining the eligibility of patients for elacestrant treatment[4].

Financial Implications

The financial trajectory of elacestrant is influenced by several factors, including its pricing, market competition, and reimbursement policies.

• Pricing: The high ICER values indicate that elacestrant is a costly treatment option, which may affect its adoption and reimbursement by healthcare payers. The pricing strategy will need to balance the need for profitability with the need to ensure access to this effective treatment[2].

• Reimbursement: The cost-effectiveness analysis suggests that elacestrant may face challenges in securing favorable reimbursement policies, particularly in the US. This could impact its market penetration and overall financial performance[2].

Future Market Scenario

The future market scenario for elacestrant will be shaped by several factors:

• Increasing Demand: The growing incidence of breast cancer and the need for effective treatments for advanced and metastatic cases will drive demand for elacestrant[3].

• Competition: The emergence of new therapies and the ongoing development of other SERDs will create a competitive landscape that elacestrant must navigate to maintain market share[3].

• Regulatory and Reimbursement Environment: Favorable regulatory designations and companion diagnostics will support elacestrant's market position, but reimbursement challenges could impact its financial performance[4].

Key Takeaways

• Clinical Efficacy: Elacestrant has demonstrated significant clinical efficacy, particularly in patients with ESR1 mutations.
• Market Growth: The market for elacestrant is expected to grow, but it will face competition from other emerging therapies.
• Cost-Effectiveness: Elacestrant is not currently cost-effective compared to standard of care, which may impact its adoption and reimbursement.
• Regulatory Support: Priority review and fast track designation, along with a companion diagnostic, support elacestrant's market position.
• Financial Trajectory: The financial performance of elacestrant will depend on its pricing strategy, market competition, and reimbursement policies.

FAQs

1. What is the mechanism of action of elacestrant? Elacestrant is a selective estrogen receptor degrader (SERD) that selectively binds to and degrades the estrogen receptor (ER), inhibiting ER-mediated signaling and the growth of ER-positive breast cancer cells[1].

2. What was the basis for the FDA approval of elacestrant? The FDA approval of elacestrant was based on the phase 3 EMERALD trial, which demonstrated a statistically significant improvement in progression-free survival (PFS) in patients with ESR1 mutations[4].

3. Is elacestrant cost-effective compared to standard of care? No, a recent cost-effectiveness analysis showed that elacestrant is not cost-effective compared to standard of care, with an ICER significantly higher than the willingness-to-pay threshold[2].

4. What are the common adverse events associated with elacestrant? Common adverse events include musculoskeletal pain, nausea, increased cholesterol, increased AST, increased triglycerides, fatigue, and others[4].

5. What is the recommended dose of elacestrant? The recommended dose of elacestrant is 345 mg taken orally with food once daily until disease progression or unacceptable toxicity[4].

Cited Sources

1. Clinical Cancer Research: "Elacestrant (RAD1901), a Selective Estrogen Receptor Degrader, in Preclinical Models of ER+ Breast Cancer"[1].
2. PubMed: "Cost-effectiveness analysis of elacestrant versus standard of care for the second-/third-line treatment of patients with ER+/HER2-A/MBC in the US"[2].
3. DelveInsight: "Elacestrant Emerging Drug Insight and Market Forecast – 2032"[3].
4. FDA: "FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer"[4].
5. Targeted Oncology: "Elacestrant Provides Treatment Path Forward in Advanced Breast Cancer"[5].