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 thirty-six 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.

Indicators of Generic Entry

Summary for ORSERDU

International Patents:	136
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	1
Patent Applications:	118
Drug Prices:	Drug price information 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	217639-001	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 ORSERDU

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	737825
Poland	3565542
Russian Federation	2017140674
Russian Federation	2745678
Russian Federation	2017140675
Serbia	64115	LEČENJE KANCERA DOJKE UPOTREBOM SELEKTIVNIH MODULATORA RECEPTORA ESTROGENA (TREATING BREAST CANCER USING SELECTIVE ESTROGEN RECEPTOR MODULATORS)
South Korea	102676629

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	3/2024	Austria		PRODUCT NAME: ELACESTRANT ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1757 (MITTEILUNG) 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	LUC00331	Luxembourg		PRODUCT NAME: ELACESTRANT OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1757 20230918
3122426	PA2024504	Lithuania		PRODUCT NAME: ELACESTRANTAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1757 20230915

Market Dynamics and Financial Trajectory for ORSERDU

Introduction to ORSERDU

ORSERDU, also known as elacestrant, is a groundbreaking oral Selective Estrogen Receptor Degrader (SERD) approved by the U.S. Food and Drug Administration (FDA) in January 2023. It is specifically designed to target ESR1-mutated tumors, which occur in up to 50% of ER+, HER2- advanced or metastatic breast cancer (mBC) patients, particularly those who have experienced disease progression following at least one line of endocrine therapy[4].

Market Growth Drivers

The market for ORSERDU is expected to exhibit significant growth driven by several key factors:

Increasing Cancer Diagnosis and Unmet Need

The rising incidence of breast cancer, particularly the ER+/HER2- subtype, and the high unmet need in the ESR1 mutation space are major drivers. ORSERDU's approval addresses a critical gap in the treatment landscape for these patients[1].

Strong Clinical Performance

ORSERDU has demonstrated statistically significant benefits in terms of median progression-free survival (mPFS) compared to standard-of-care treatments. For patients who have been treated with CDK4/6 inhibitors for at least 12 months, ORSERDU showed a mPFS of 8.6 months, significantly outperforming standard therapies[3].

Convenience and Patient Compliance

Unlike traditional intramuscularly administered SERDs, ORSERDU is administered orally once daily, offering a more convenient and less painful treatment option. This convenience is expected to enhance patient compliance and overall treatment outcomes[3].

Financial Performance and Projections

The financial trajectory of ORSERDU is promising and is supported by several key indicators:

Revenue Projections

DRI Healthcare Trust expects ORSERDU sales to reach at least $175 million in 2023, reflecting strong physician feedback and better-than-expected performance since its launch. By 2034, ORSERDU, along with other oral SERDs like camizestrant, giredestrant, and imlunestrant, is projected to generate an estimated revenue of $3 billion in the U.S. alone for metastatic settings[1][3].

Royalty Agreements and Investments

DRI Healthcare Trust has acquired a second royalty interest in the worldwide net sales of ORSERDU for an upfront purchase price of $130 million, with potential milestone payments of up to $69 million. This investment underscores the confidence in ORSERDU's market potential and clinical benefits[3].

List Price and Cost of Therapy

ORSERDU was launched at a list price of approximately $21,000 per month. Based on its median PFS of 8.6 months in ESR1 patients, the annual cost of therapy is estimated to be around $180,000. Despite the high cost, the drug's efficacy and convenience are expected to drive adoption[1].

Market Dynamics and Competitive Landscape

The market for SERDs, including ORSERDU, is characterized by several dynamic factors:

Competitive Environment

The SERD market is becoming increasingly competitive with multiple players, including AstraZeneca, Eli Lilly, and Roche, developing and launching new oral SERDs. This competition accelerates innovation but also leads to market fragmentation as various players vie for market share[1].

Regulatory and Reimbursement Factors

Regulatory approvals and reimbursement policies significantly impact the market dynamics. The speed at which new SERDs are approved and the willingness of insurance and healthcare systems to cover these therapies can influence adoption rates and market growth[1].

Patent Expirations and Generic Competitors

The patent expirations of existing SERD products can open opportunities for generic competitors, influencing pricing and market share. This could potentially affect the revenue trajectory of branded SERDs like ORSERDU[1].

Real-World Efficacy and Patient Outcomes

Recent data presented at the 2024 San Antonio Breast Cancer Symposium (SABCS) highlighted the real-world efficacy of ORSERDU. The overall population analysis demonstrated a median real-world progression-free survival (rwPFS) of 6.8 months, with consistent results across various patient subgroups. This real-world data reinforces the clinical benefits observed in trials[4].

Investor and Stakeholder Confidence

The acquisition of royalty interests by DRI Healthcare Trust and the positive feedback from physicians indicate strong confidence in ORSERDU's market potential. The trust's financial results, including milestone royalty income upon EMA approval of ORSERDU, further underscore this confidence[3][5].

Key Takeaways

• ORSERDU is poised for significant market growth due to its strong clinical performance, convenience, and addressing a high unmet need in the ESR1 mutation space.
• Revenue projections are robust, with expected sales reaching $175 million in 2023 and potentially $3 billion by 2034 in the U.S. for metastatic settings.
• The competitive landscape is dynamic, with regulatory and reimbursement factors playing crucial roles.
• Real-world efficacy data supports the drug's clinical benefits, enhancing its market position.

FAQs

What is ORSERDU, and how does it differ from other SERDs?

ORSERDU is an oral Selective Estrogen Receptor Degrader (SERD) specifically designed to target ESR1-mutated tumors in ER+, HER2- advanced or metastatic breast cancer patients. Unlike traditional SERDs, ORSERDU is administered orally once daily, offering a more convenient and less painful treatment option[3].

What are the key drivers of ORSERDU's market growth?

The key drivers include increasing cancer diagnosis, high unmet need in the ESR1 mutation space, strong clinical performance, and the convenience of oral administration[1].

How much is ORSERDU expected to generate in revenue by 2034?

By 2034, ORSERDU, along with other oral SERDs, is projected to generate an estimated revenue of $3 billion in the U.S. alone for metastatic settings[1].

What is the current list price of ORSERDU, and what is the estimated annual cost of therapy?

ORSERDU was launched at a list price of approximately $21,000 per month, with an estimated annual cost of therapy around $180,000 based on its median PFS of 8.6 months in ESR1 patients[1].

How does the competitive landscape affect ORSERDU's market position?

The competitive landscape is dynamic, with multiple players developing new oral SERDs. This competition accelerates innovation but can also lead to market fragmentation. Regulatory approvals and reimbursement policies further impact market dynamics[1].

Cited Sources:

1. GlobeNewswire: "SERD Market is Predicted to Exhibit Remarkable Growth Owing to the Usage of Faslodex in Combination, Strong Performance of ORSERDU, and Speedy Progress of Other Oral SERDs, During the Study Period (2020–2034)".
2. Guardant Health: "Guardant Health Reports Fourth Quarter and Full Year 2022 Financial Results and Provides 2023 Outlook".
3. Newswire.ca: "DRI Healthcare Trust Announces Acquisition of a Second Royalty Interest in the Worldwide Sales of ORSERDU®".
4. Stemline: "Menarini Group Presents New and Expanded Data at the 2024 San Antonio Breast Cancer Symposium".
5. DRI Healthcare: "DRI Healthcare Trust Reports Fourth Quarter and Fiscal 2023 Results".