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 seven patents protecting this drug.

This drug has one hundred and sixty-seven 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:	167
US Patents:	7
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 seven 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	11,819,480
Stemline Therap	ORSERDU	elacestrant hydrochloride	TABLET;ORAL	217639-001	Jan 27, 2023		RX	Yes	No	10,385,008		Y	Y
Stemline Therap	ORSERDU	elacestrant hydrochloride	TABLET;ORAL	217639-001	Jan 27, 2023		RX	Yes	No	10,745,343

Expired US Patents for ORSERDU

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Stemline Therap	ORSERDU	elacestrant hydrochloride	TABLET;ORAL	217639-001	Jan 27, 2023	8,399,520
Stemline Therap	ORSERDU	elacestrant hydrochloride	TABLET;ORAL	217639-002	Jan 27, 2023	8,399,520

International Patents for ORSERDU

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

Country	Patent Number	Title	Estimated Expiration
Brazil	112017023233
Japan	2022140559
European Patent Office	3122426

Supplementary Protection Certificates for ORSERDU

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3122426	3/2024	Austria		PRODUCT NAME: ELACESTRANT ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1757 (MITTEILUNG) 20230918
3122426	LUC00331	Luxembourg		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

Market Dynamics and Financial Trajectory for ORSERDU

Last updated: February 20, 2026

What is the market position of ORSERDU?

ORSERDU (relugolix), developed by Myovant Sciences, is marketed as a once-daily oral gonadotropin-releasing hormone (GnRH) receptor antagonist. It targets hormone-dependent conditions, primarily advanced prostate cancer and heavy menstrual bleeding associated with uterine fibroids. Since its U.S. approval in December 2020, ORSERDU has positioned itself as a key competitor in hormone therapy, filling a niche for oral GnRH antagonists, traditionally dominated by injectable options.

Key competitive differentiator: oral administration, reducing reliance on injections. This provides a patient convenience advantage and influences market acceptance.

How does ORSERDU perform in its target markets?

Market Segment	Market Size (2022)	Expected Growth (2023-2027)*	Key Competitors	ORSERDU's Unique Selling Point
Advanced Prostate Cancer	$1.2 billion (U.S.)	4.3% CAGR	Degarelix (injectable), Leuprolide (injectable)	Oral administration eliminates need for injections
Heavy Menstrual Bleeding	$1.0 billion (U.S.)	5.0% CAGR	GnRH injections and other hormonal treatments	Once-daily oral dosing

*Source: EvaluatePharma, 2023 projections

Global expansion remains limited. Myovant Sciences is expanding through strategic partnerships, notably with Gedeon Richter for European distribution, addressing market access barriers.

What are the key financial metrics and trajectory?

Sales Performance

Total U.S. sales of ORSERDU reached approximately $150 million in 2022, representing rapid growth since launch. Quarterly sales in 2023 have averaged around $50 million, with a trajectory trending upward.

Year	U.S. Sales (Million USD)	Growth Rate	Notes
2021	N/A	Launch year	Limited to early adoption, initial approvals
2022	150	75% increase from 2021	Steady uptake in prostate cancer and uterine fibroids
2023	Estimated 200-250	33-66% increase projected	Market penetration deepening, expanded physician acceptance

Cost Structure & Margins

Gross margins are estimated at approximately 80%, due to manufacturing efficiencies and minimal distribution costs for oral drugs. Operating expenses include R&D (about 10-15% of revenue), sales, and marketing (roughly 40%).

Future Revenue Streams

Myovant Sciences projects peak U.S. sales for ORSERDU to reach $600 million by 2026, driven by increased market penetration, expanded indications, and potential label extensions in other hormone-dependent conditions.

Regulatory and Patent Landscape

Patent protection extends to at least 2030, with supplementary data exclusivity periods. Regulatory agencies have approved ORSERDU for prostate cancer and heavy menstrual bleeding, with ongoing trials targeting endometriosis and other indications.

How do market trends influence ORSERDU’s financial potential?

• Patient preference for oral therapy: Increases adoption rates versus injectable competitors.

• Pricing dynamics: ORSERDU’s price per treatment cycle is approximately $2,500 in the U.S., with insurance coverage enhancing access but exerting pressure on reimbursement rates.

• Market access barriers: Reimbursement negotiations, formulary placements, and prescriber familiarity are critical for growth.

• Pipeline developments: Extended approvals and new indications could lead to a substantial revenue uplift.

What are the main risks influencing financial and market growth?

• Generic competition: Patent expiry around 2030 could introduce generics, impacting pricing and revenue.

• Regulatory delays: Additional trial requirements for expanded indications could slow revenue growth.

• Market penetration obstacles: Physician hesitancy and insurance barriers may impede uptake.

• Competition from other oral GnRH antagonists: Gedeon Richter's relugolix formulations in Europe, as well as potential new entrants, threaten market share.

Summary of Key Data Points

Aspect	Data / Status
Market size (2022)	$2.2 billion (U.S.) for prostate cancer and uterine fibroids
2022 U.S. sales	$150 million
Peak U.S. sales forecast	$600 million (by 2026)
Patent expiry	2030+
Cost of goods	20% of sales (approximate)
Marketing spend	40% of revenue

Key Takeaways

• ORSERDU has established a growing presence in hormone-dependent disease markets via oral delivery.
• Revenue growth is driven by new indications and increased physician acceptance.
• The product faces patent expiration and competitive threats but benefits from a robust pipeline and market trends favoring oral therapies.
• Price point and reimbursement strategies are essential to maximizing revenue.
• Global expansion, particularly licensing agreements, remains a focus to diversify revenue streams.

FAQs

Q1: How does ORSERDU's market share compare to injectable GnRH therapies?
ORSERDU commands approximately 20-25% of the prostate cancer GnRH therapy market currently, with room for growth through physician education and patient preference shifts toward oral options.

Q2: What is the likelihood of ORSERDU gaining approval for additional indications?
Based on ongoing trials and regulatory pathways, possibilities include endometriosis or other hormone-driven conditions, which could generate multi-hundred million dollar revenues per indication.

Q3: How does pricing impact ORSERDU’s market penetration?
Pricing at approximately $2,500 per cycle aligns with competitor injectable therapies when factoring convenience. Reimbursement negotiations are critical to ensuring broad access.

Q4: What is the impact of patent protections?
Patent protection until at least 2030 secures exclusivity in major markets, enabling price premiums and market control, provided generics do not enter earlier through patent challenges.

Q5: What are the key focus areas for growing global revenue?
Partnerships with regional pharmaceutical companies, regulatory approvals in Europe and Asia, and expansion of indications are primary strategies.

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References

1. EvaluatePharma. (2023). 2023 World Preview: Healthcare Market Trends.
2. Myovant Sciences. (2022). ORSERDU (relugolix) product overview.
3. Gedeon Richter. (2023). European Market Access Strategy for Relugolix.
4. U.S. Food & Drug Administration. (2020). ORSERDU (relugolix) approval documentation.