ELAGOLIX SODIUM - Generic Drug Details

What are the generic drug sources for elagolix sodium and what is the scope of freedom to operate?

Elagolix sodium is the generic ingredient in two branded drugs marketed by Abbvie and is included in two NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Elagolix sodium has one hundred and four patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for ELAGOLIX SODIUM

International Patents:	104
US Patents:	13
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	8
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ELAGOLIX SODIUM
DailyMed Link:	ELAGOLIX SODIUM at DailyMed

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

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 ELAGOLIX SODIUM

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

Sponsor	Phase
AbbVie	Phase 3
AbbVie (prior sponsor, Abbott)	Phase 2
AbbVie	Phase 2

See all ELAGOLIX SODIUM clinical trials

Pharmacology for ELAGOLIX SODIUM

Drug Class	Gonadotropin Releasing Hormone Receptor Antagonist
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A Inducers Gonadotropin Releasing Hormone Receptor Antagonists P-Glycoprotein Inhibitors
Physiological Effect	Decreased GnRH Secretion

Anatomical Therapeutic Chemical (ATC) Classes for ELAGOLIX SODIUM

H01CC	Anti-gonadotropin-releasing hormones
H01C	HYPOTHALAMIC HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

Paragraph IV (Patent) Challenges for ELAGOLIX SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ORILISSA	Tablets	elagolix sodium	150 mg and 200 mg	210450	9	2022-07-25

US Patents and Regulatory Information for ELAGOLIX SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018		RX	Yes	No
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018		RX	Yes	No
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-002	Jul 23, 2018		RX	Yes	Yes			Y	Y

Expired US Patents for ELAGOLIX SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-002	Jul 23, 2018
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-002	Jul 23, 2018

International Patents for ELAGOLIX SODIUM

Country	Patent Number	Title	Estimated Expiration
Brazil	112020003380
Hong Kong	1258062
Japan	6159870

Market Dynamics and Financial Trajectory for Elagolix Sodium

Last updated: July 27, 2025

Introduction
Elagolix sodium stands as a noteworthy pharmaceutical agent within the realm of hormone regulation therapies, primarily marketed for conditions such as endometriosis and uterine fibroids. As a selective GnRH (gonadotropin-releasing hormone) antagonist, it disrupts estrogen production, providing targeted symptom management with a potentially improved safety profile over traditional therapies. Its market trajectory hinges on evolving clinical applications, regulatory landscape, competitive positioning, and the broader healthcare environment.

Market Landscape and Therapeutic Demand

Elagolix sodium’s initial approval by the U.S. Food and Drug Administration (FDA) in 2018 for the management of moderate to severe pain associated with endometriosis marked its entry into a competitive arena. Endometriosis affects approximately 10% of women of reproductive age worldwide, representing a substantial unmet medical need with an estimated global market exceeding $3 billion by 2025 [1]. As a non-hormonal alternative with a shorter treatment duration and fewer systemic side effects, elagolix fulfills a significant niche.

In addition to endometriosis, ongoing clinical trials explore elagolix’s efficacy for uterine fibroids, hypothalamic amenorrhea, and other estrogen-dependent conditions. Successful expansion into these indications could enhance its market potential, aligning with the growing demand for targeted, non-surgical treatment options for women’s health.

Regulatory and Reimbursement Factors

Regulatory decisions significantly influence elagolix's market trajectory. The FDA's approval relied on demonstrating efficacy in pain reduction with an acceptable safety profile, though precursor concerns about bone mineral density (BMD) loss required post-marketing risk mitigation strategies, including BMD monitoring and limited treatment duration [2].

Reimbursement policies further shape commercial viability. Gaining favorable insurance coverage and inclusion in formularies has facilitated broader access. The alignment of pricing strategies with healthcare payers influences adoption rates across different regions.

Competitive Landscape and Market Positioning

Elagolix's primary competitors include Leuprolide and GnRH analogs, historically used for endometriosis treatment. These agents, however, often present drawbacks such as injection-related discomfort and hypoestrogenic side effects. Elagolix, being an oral agent, offers improved patient adherence and convenience.

Emerging competitors include other oral GnRH antagonists such as relugolix, which are under development or nearing approval. The competitive advantage of elagolix hinges on clinical differentiation, efficacy, safety profiles, and patient-centric features. Strategic partnerships, such as collaborations with pharmaceutical giants, bolster its market penetration.

Pricing and Revenue Projections

Elagolix’s pricing is calibrated against existing therapies, balancing affordability and return on investment. Initial treatment courses typically involve a 6-month regimen, consistent with FDA labeling. Current annual treatment costs are estimated between $1,200 and $2,000, positioning it competitively within the hormonal therapy domain [3].

Financial forecasts suggest steady revenue growth driven by increased uptake, market expansion, and new indications. According to industry analysts, the global market for elagolix is projected to reach approximately $1.5–2 billion within the next five years, contingent on successful indication expansion and market acceptance [4].

Market Risks and Challenges

Notwithstanding positive prospects, elagolix faces several risks. Safety concerns, notably the potential for BMD reduction, necessitate vigilant monitoring and limit long-term use. Regulatory hurdles in different geographies may slow adoption. Additionally, price competition from biosimilars or generics of competing therapies could pressure margins.

Furthermore, patient tolerability, especially in populations requiring longer or repeated courses, may influence adherence and overall market penetration. Wide-ranging healthcare policies regarding women's health and hormonal treatments also impact commercial success.

Future Outlook and Innovation Trajectories

The future of elagolix sodium is poised on the brink of indication diversification, driven by ongoing R&D initiatives. Its mechanism of action suggests utility in other estrogen-dependent conditions, such as fibroids, with pivotal trials for uterine fibroids showing promising results [5].

Advancements in drug delivery, potentially including sustained-release formulations or combination therapies, could augment its efficacy and safety profile, further solidifying its position in personalized medicine frameworks. The competitive landscape is expected to evolve as new competitors enter or as existing players innovate, necessitating proactive strategic positioning by manufacturers.

Conclusion
Elagolix sodium's market dynamics are characterized by a growing demand for non-invasive, manageable therapies for endometriosis and beyond. Its IOT (initial organic traction) was supported by regulatory approval and significant clinical evidence, with a clear path for expansion contingent upon ongoing efficacy and safety results. While facing robust competition and market entry barriers, its patient-centric benefits and strategic positioning advocate for a favorable financial trajectory in the foreseeable future.

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Key Takeaways

• Market Potential: Elagolix is well-positioned within the women’s health therapeutics market, projected to reach $1.5–2 billion globally in the next five years, driven by expanding indications.
• Regulatory Impact: Post-marketing safety measures have shaped its usage parameters, with continued vigilance essential for maintaining market access.
• Competitive Edge: Its oral administration confers a significant advantage over injectable GnRH analogs, although emerging competitors threaten to challenge its market share.
• Pricing Strategy: Competitive pricing aligned with reimbursement policies supports broader access, aiding in revenue growth.
• Innovation and Expansion: Ongoing clinical trials for additional indications and new formulations will be crucial for sustaining long-term growth and addressing unmet needs.

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FAQs

1. What medical conditions does elagolix sodium target?
Elagolix sodium is FDA-approved for treating moderate to severe pain associated with endometriosis. Clinical trials are investigating its efficacy for uterine fibroids and other estrogen-dependent conditions.

2. What are the primary safety concerns associated with elagolix?
The main safety concern relates to bone mineral density reduction due to suppressed estrogen levels. Post-marketing risk mitigation strategies include BMD monitoring and limiting duration of use.

3. How does elagolix compare to traditional therapies for endometriosis?
Unlike injectable GnRH analogs, elagolix offers oral administration, shorter treatment courses, and potentially fewer systemic side effects, improving patient adherence.

4. What factors influence elagolix’s market success?
Regulatory approval stability, safety profile, reimbursement and insurance coverage, competitive landscape, and continued indication expansion are critical.

5. What is the outlook for elagolix in the next five years?
Its market outlook remains positive, with potential growth driven by new indications, formulation innovations, and increasing awareness of women’s hormone health management, notwithstanding competitive pressures.

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Sources
[1] Think Women’s Health Market Report 2022.
[2] FDA Label for Elagolix (Orilissa).
[3] Industry pricing analyses, PharmaMarketWatch, 2022.
[4] Global Endometriosis Treatment Market Forecast 2022–2027, MarketsandMarkets.
[5] ClinicalTrials.gov, Uterine Fibroids Elagolix Studies.