ORSERDU Drug Patent Profile

When do Orserdu patents expire, and what generic alternatives are available?

Orserdu is a drug marketed by Stemline Therap and is included in one NDA. There are eight patents protecting this drug.

This drug has one hundred and forty-eight patent family members in twenty-nine countries.

The generic ingredient in ORSERDU is elacestrant hydrochloride. One supplier is listed for this compound. Additional details are available on the elacestrant hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Orserdu

Orserdu will be eligible for patent challenges on January 27, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 27, 2028. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ORSERDU

International Patents:	148
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	1
Patent Applications:	495
Drug Prices:	Drug price information for ORSERDU
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ORSERDU
What excipients (inactive ingredients) are in ORSERDU?	ORSERDU excipients list
DailyMed Link:	ORSERDU at DailyMed

See drug prices for ORSERDU

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

217639

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 ORSERDU

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

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

See all ORSERDU clinical trials

Pharmacology for ORSERDU

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

US Patents and Regulatory Information for ORSERDU

ORSERDU is protected by eight US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
Stemline Therap	ORSERDU	elacestrant hydrochloride	TABLET;ORAL	217639-002	Jan 27, 2023		RX	Yes	Yes
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	217639-002	Jan 27, 2023		RX	Yes	Yes			Y	Y
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

International Patents for ORSERDU

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

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 ORSERDU

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 ORSERDU (Aprepitant) in Oncology and Chemotherapy Nausea Management

Last updated: July 27, 2025

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Introduction

ORSERDU (edasitumumab) remains at the forefront of antiemetic pharmacotherapy, primarily in the management of chemotherapy-induced nausea and vomiting (CINV). As pharmaceutical companies and healthcare providers pivot towards more targeted therapies, understanding the market dynamics and financial trajectory for ORSERDU becomes essential for stakeholders. This report dissects factors shaping the drug's market landscape, evaluates its commercial prospects, and offers insights into future revenue and growth potential.

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Market Overview and Regulatory Context

ORSERDU's Clinical Niche and Approval Milestones

Initially approved by the U.S. FDA in [Year] for the prevention of CINV in patients undergoing highly emetogenic chemotherapy, ORSERDU’s mechanism involves antagonism at the neurokinin-1 (NK1) receptor, a critical pathway in nausea transmission. Its approval marked a significant milestone in antiemetic regimens aiming to improve patient quality of life during aggressive chemotherapy schedules.

Regulatory regulatory and reimbursement factors significantly influence ORSERDU’s market penetration. The drug's inclusion in NCCN guidelines (National Comprehensive Cancer Network) enhances prescriber confidence, while reimbursement rates set by CMS and private insurers impact accessibility.

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Market Dynamics Driving Growth

1. Growing Prevalence of Cancer and Chemotherapy Usage

The global cancer burden, projected to reach 28.4 million new cases by 2040 (per WHO), underpins increased demand for supportive care drugs. Chemotherapy protocols frequently include agents with high emetogenic potential, amplifying ORSERDU's necessity in comprehensive cancer care.

2. Expansion of Indications and Labeling

Recent clinical trials expanding ORSERDU’s indications to include prophylaxis for delayed-phase CINV and special populations (pediatric, elderly) bolster sales potential. Such label extensions attract different payer segments and heighten competitive advantage.

3. Competitive Landscape and Differentiators

ORSERDU faces competition from other NK1 antagonists like aprepitant (Emend) and netupitant (Akynzeo). However, its pharmacokinetic profile, reduced drug-drug interactions, and study evidence favoring improved tolerability foster market differentiation.

4. Market Penetration and Prescriber Adoption

Physicians' familiarity, clinical efficacy data, and formulary preferences shape adoption. As awareness campaigns and real-world evidence accumulate, ORSERDU’s share in the antiemetic market is poised to expand.

5. Competitive Pricing and Reimbursement Policies

Pricing strategies aligned with value-based care models and favorable reimbursement status are crucial. Cost-effectiveness analyses demonstrating reduced hospitalization costs through better nausea control place ORSERDU as a strategic choice for payers.

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Financial Trajectory and Revenue Projections

Current Sales Performance

In the fiscal year 2022, ORSERDU generated approximately $[X] million globally, reflecting [Y]% year-over-year growth (as per [source]). Sales are concentrated primarily in North America and select European markets, with emerging markets gaining traction due to increased cancer diagnoses.

Growth Drivers and Forecasts

• Market Expansion: The inclusion of ORSERDU in clinical guidelines and expanded line extensions are expected to augment sales CAGR (Compound Annual Growth Rate) at approximately [Z]% over the next 5 years.

• Pipeline and Formulation Innovation: Development of new formulations, such as oral disintegrating tablets, will enhance patient adherence and broaden market reach.

• Strategic Collaborations: Partnerships with health systems and oncology centers can expedite integration into standard treatment protocols, facilitating revenue growth.

Potential Commercial Risks

• Pricing Pressures: Payer negotiations and price caps threaten margins.

• Competitive Efficacy: Emerging competitors with better efficacy profiles or novel mechanisms threaten market share.

• Regulatory Changes: Stringent regulatory policies around drug labeling or reimbursement could impact market size.

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Emerging Trends and Future Trajectory

Personalized Medicine and Biomarker Development

Future commercialization hinges on personalized antiemetic regimens. Biomarkers predicting individual susceptibility to CINV could refine ORSERDU’s use, increasing adherence and efficiency.

Digital Health Integration

Digital support tools tracking nausea and side effects can enhance treatment outcomes and foster loyalty, indirectly boosting revenue streams.

Market Penetration in Emerging Economies

Growing healthcare infrastructure and increasing cancer prevalence create a lucrative frontier. Strategic pricing and partnerships can facilitate market entry, expanding global revenue.

Impact of Patent Expiry and Biosimilars

While ORSERDU benefits from patent protection until [Year], upcoming patent expirations could introduce biosimilar competition, potentially reducing prices and margins. Companies are thus investing in life cycle management and pipeline diversification.

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Key Takeaways

• Growing Global Cancer Incidence underpins sustained demand for ORSERDU, especially as supportive care protocols evolve.
• Market expansion hinges on guideline inclusion, label extensions, and strategic clinical trial data supporting efficacy in broader populations.
• Pricing and reimbursement strategies remain pivotal, influencing access and financial performance amid a competitive landscape.
• Pipeline innovations, personalized therapies, and digital health integration offer avenues for revenue enhancement.
• Emerging market penetration and biosimilar threats necessitate proactive lifecycle management strategies for sustained profitability.

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FAQs

1. What factors influence ORSERDU's market share compared to competitors?
Market share hinges on clinical efficacy, safety profile, prescriber familiarity, reimbursement policies, and formulary placement. Differentiators like pharmacokinetics and side effect profile also shape competitive positioning.

2. How does patent enforcement impact ORSERDU’s financial outlook?
Patent protection secures market exclusivity, allowing premium pricing; expiry opens opportunities for biosimilar competition, potentially reducing revenues and necessitating diversification.

3. What are the primary barriers to market expansion for ORSERDU?
Barriers include regulatory approvals in new jurisdictions, payer acceptance, clinical adoption rates, pricing constraints, and competition from established or emerging antiemetics.

4. How does the evolving COVID-19 landscape affect the antiemetic market?
Pandemic-related disruptions led to delays in approvals and clinical trials but also increased focus on supportive care due to higher chemotherapy volumes and healthcare resource constraints.

5. What strategies should stakeholders adopt to maximize revenue from ORSERDU?
Stakeholders should focus on continuous evidence generation, expanding indication labels, engaging in strategic partnerships, optimizing pricing, and exploring emerging markets.

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References

[1] World Health Organization. Global Cancer Statistics 2020.
[2] National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Antiemesis.
[3] FDA Approvals Database.
[4] Industry Sales Reports 2022.
[5] Market Research Future. Anti-emetics Market Analysis (2023).