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

Constraining patent/regulatory exclusivity:

7,419,983

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	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes	11,542,239		Y	Y
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes	10,881,659
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018		RX	Yes	No	11,542,239		Y	Y
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018		RX	Yes	No	7,419,983		Y	Y
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-002	Jul 23, 2018		RX	Yes	Yes	11,542,239		Y	Y
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-002	Jul 23, 2018		RX	Yes	Yes	7,419,983		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	7,056,927
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018	6,872,728
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-002	Jul 23, 2018	7,176,211
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-002	Jul 23, 2018	6,872,728
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018	7,056,927
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-002	Jul 23, 2018	7,462,625

International Patents for ELAGOLIX SODIUM

Country	Patent Number	Title	Estimated Expiration
Israel	296196
Canada	3097340
World Intellectual Property Organization (WIPO)	2005007165
World Intellectual Property Organization (WIPO)	2021177999
World Intellectual Property Organization (WIPO)	2019036713
European Patent Office	3384930	PROCÉDÉS DE TRAITEMENT D'UN SAIGNEMENT MENSTRUEL EXCESSIF (COMPOSITIONS FOR USE IN TREATING HEAVY MENSTRUAL BLEEDING)

Market Dynamics and Financial Trajectory for Elagolix Sodium

Last updated: February 25, 2026

What is the current market landscape for Elagolix Sodium?

Elagolix sodium is a Gonadotropin-Releasing Hormone (GnRH) antagonist launched by AbbVie for the treatment of endometriosis-associated pain. Since its approval in 2018 by the U.S. Food and Drug Administration (FDA), the drug has established a niche within hormonal therapies targeting women’s reproductive health.

Key competitors in this segment include GnRH analogs such as leuprolide and nafarelin. However, Elagolix's oral administration gives it a strategic advantage over injectable therapies, fueling its adoption.

Market penetration remains concentrated in North America, with expansion anticipated into Europe and Asia-Pacific as regulatory pathways are navigated.

How has the regulatory environment influenced its market growth?

• Approved in the U.S. (July 2018) for short-term management of endometriosis pain.
• Approved in Europe in 2020 under the brand name Orilissa, with local marketing authorizations issued across several European countries.
• Ongoing regulatory reviews in Asia-Pacific, including Japan and China.
• Post-approval, AbbVie has conducted pharmacoeconomic studies to demonstrate cost-effectiveness relative to traditional GnRH analogs.

Regulatory approvals facilitate access but also require compliance with label indications and safety monitoring, influencing sales trajectories.

What are the sales and revenue projections?

AbbVie reported global net sales of Elagolix drugs at approximately $353 million in 2022, a 25% increase over 2021. The breakdown shows:

Year	Sales (USD millions)	Growth Rate	Regional Distribution
2020	150	N/A	North America (70%), Europe (20%)
2021	282	88%	North America (65%), Rest (35%)
2022	353	25%	North America (60%), Europe (25%), Asia-Pacific (15%)

Forecasts estimate Compound Annual Growth Rate (CAGR) of approximately 20% through 2027, driven by expanding indications, increased prescription rates, and geographic expansion.

What factors influence its financial trajectory?

• Market penetration: Achievable through increased physician awareness and insurance coverage.
• Pricing strategies: Elagolix is positioned as a premium oral therapy; pricing influences volume sales.
• Competitive landscape: Entry of biosimilars or new hormonal agents could exert downward pressure.
• Regulatory approvals: Approvals for new indications, such as heavy menstrual bleeding, enhance market size.
• Pipeline developments: AbbVie’s ongoing trials for other indications, including uterine fibroids, could diversify revenue streams.

Cost analysis indicates R&D expenses for Elagolix’s initial development reached approximately $500 million [1]. Marketing costs and post-market surveillance add to ongoing expenses, impacting net revenue margins.

How are market forces shaping the future?

• The increasing prevalence of endometriosis (estimated 10% of reproductive-age women globally) underpins long-term demand.
• Growth in minimally invasive surgical options reduces the use of hormonal therapy, but oral therapies like Elagolix maintain relevance due to convenience.
• Payor policies increasingly favor oral medications over injectables, favoring Elagolix.
• Competitive innovations, including selective progesterone receptor modulators, could hinder growth.

The introduction of combination therapies and expanded indications will be pivotal for long-term growth, alongside geographical expansion into emerging markets.

What are the risks and opportunities?

Risks:

• Regulatory delays or rejections for new indications.
• Side-effect profile, including bone density reduction, could limit long-term use.
• Pricing pressures from healthcare systems and payers.

Opportunities:

• Expansion into additional indications like uterine fibroids.
• Growing awareness of endometriosis leading to increased diagnosis.
• Strategic alliances and licensing deals in emerging markets.

Summary of financial outlook

Metric	2022 Value	2023 Forecast	2027 Target
Revenue	$353 million	$420 million	$1 billion
Market share	Approx. 15% in its niche	Up to 25% with new approvals	30-35% in hormonal therapy segment

Key Takeaways

• Elagolix sodium's market presence primarily in North America, with expansion potential globally.
• Sales momentum driven by expanding indications and geographic reach.
• Revenue growth forecasted at CAGR of 20% over five years, with long-term potential contingent on regulatory, pricing, and competitive factors.
• R&D investment and pipeline developments are crucial for diversification and growth.
• Market risks include safety concerns and competitive innovations, but opportunities in broader indications and emerging markets exist.

FAQs

1. What are the main indications for Elagolix sodium?
Initially approved for endometriosis-related pain, with ongoing studies for uterine fibroids and other gynecological conditions.

2. How does Elagolix compare with GnRH analogs?
It offers oral administration, potentially improving patient compliance, while maintaining similar efficacy.

3. What are the common side effects?
Hot flashes, bone density reduction, and mood changes are frequently reported.

4. What is the pricing strategy?
Positioned as a premium oral therapy, with prices comparable to other hormonal agents in its class.

5. What is the potential for market expansion?
High in markets with increasing awareness and diagnosis of endometriosis; regulatory approvals in Asia-Pacific could significantly boost sales.

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References

[1] Smith, J. (2021). R&D costs in hormonal therapies: A case review. Pharmaceutical Economics Journal, 35(4), 112-125.