ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM - Generic Drug Details

What are the generic sources for elagolix sodium,estradiol,norethindrone acetate; elagolix sodium and what is the scope of patent protection?

Elagolix sodium,estradiol,norethindrone acetate; elagolix sodium is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Elagolix sodium,estradiol,norethindrone acetate; elagolix sodium has ninety-nine patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM

International Patents:	99
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
DailyMed Link:	ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM

Dosage:

CAPSULE;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.

Anatomical Therapeutic Chemical (ATC) Classes for ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ORIAHNN (COPACKAGED)	Capsules	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	300 mg/1 mg/ 0.5 mg; 300 mg	213388	1	2022-11-03

US Patents and Regulatory Information for ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; 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			Y	Y
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes			Y
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes

Expired US Patents for ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020

International Patents for ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM

Country	Patent Number	Title	Estimated Expiration
Brazil	112020003388
Brazil	PI0412314	derivados de pirimidina-2,4-diona como antagonistas de receptor de hormÈnio liberador de gonadotropina
Israel	241595

Market Dynamics and Financial Trajectory for Elagolix Sodium, Estradiol, Norethindrone Acetate

Last updated: July 27, 2025

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Introduction

The pharmaceutical landscape surrounding elagolix sodium, estradiol, and norethindrone acetate presents a compelling case for investors and industry stakeholders. These compounds, integral to hormonal therapies, embody both therapeutic promise and commercial potential amidst evolving regulatory, clinical, and competitive environments. This report delineates the market dynamics and financial trajectory of these drugs, with a primary focus on elagolix sodium phases, applications, and future prospects.

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Pharmacological Profile and Therapeutic Applications

Elagolix sodium—a gonadotropin-releasing hormone (GnRH) antagonist—targets conditions driven by hormonal dysregulation such as endometriosis and uterine fibroids. Its mechanism allows for reversible suppression of ovarian hormone production, offering advantages over traditional therapies.

Estradiol—a vital estrogen hormone—is employed in hormone replacement therapy (HRT), oral contraceptives, and transgender medicine. Its role in modulating estrogenic activity makes it a cornerstone in female reproductive health.

Norethindrone acetate—a progestin used in contraceptive formulations and HRT—works synergistically or independently with estrogens to prevent pregnancy and treat menopausal symptoms.

Market Drivers

Growing Prevalence of Hormonal Disorders

An increasing incidence of endometriosis, uterine fibroids, and menopausal symptoms fuels demand for effective hormonal therapies. The endometriosis market alone is projected to reach USD 13 billion globally by 2027, with elagolix contributing significantly following its FDA approval in 2018 (as Narcanex®) for this indication [1].

Regulatory Approvals and Expanding Indications

Elagolix's favorable clinical profile yielded expanded indications, including management of uterine fibroids and off-label opportunities. The FDA approval of elagolix for endometriosis dented new market segments, reinforcing its commercial trajectory.

Patient Preference for Reversible, Oral Therapies

The shift towards oral, reversible hormonal treatments enhances elagolix’s attractiveness over injectable GnRH analogs, pushing market adoption.

Pipeline and R&D Trends

Ongoing clinical trials exploring elagolix combination therapies, dose optimization, and new indications are likely to extend its market lifespan and revenue streams.

Competitive Landscape

Key Players

AbbVie, the original manufacturer of elagolix (brand name: Orilissa®), remains the leader post-launch. Other competitors include neurocrine biosciences and generics manufacturers, aiming to introduce biosimilars or alternative therapies.

Market Penetration

Elagolix’s market penetration is influenced by clinician adoption rates, insurance coverage, and promotional strategies. The drug’s patent expiry is imminent, raising prospects for biosimilar entries that could disrupt pricing and market share.

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Market Challenges

Regulatory Hurdles and Off-Label Use Risks

Regulatory approvals for broader indications are essential for market growth but are subject to clinical trial outcomes and safety data. Off-label use poses both opportunity and risk, including regulatory scrutiny.

Pricing and Reimbursement Pressures

Cost containment efforts and insurance reconsiderations threaten optimal reimbursement. With the impending patent expiration, generic competition could lead to significant price erosion.

Safety and Side Effect Profile

Potential adverse effects—such as bone mineral density reduction associated with GnRH antagonists—necessitate careful risk management, impacting prescribing patterns and clinical adoption.

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Financial Trajectory and Revenue Forecasts

Historical Performance

Following its 2018 market debut, elagolix generated approximately USD 250 million in global sales in 2020, with expectations of growth driven by expanding indications and increasing patient access [2].

Projection Models

Many analysts project compounded annual growth rates (CAGR) of 10-15% for elagolix from 2023 to 2030, fueled by:

• Market expansion: Moving beyond endometriosis into fibroids and possibly postpartum hyperprolactinemia.
• Market penetration: Increasing awareness and physician adoption.
• Pricing strategies: Adoption of value-based pricing, especially in developed markets.

Impact of Patent Expiry and Biosimilar Entry

Patent expiration, anticipated around 2026, could lead to a revenue decline of up to 40-50%, contingent on biosimilar competition and regulatory pathways.

Potential for Combination Products and New Formulations

R&D efforts exploring fixed-dose combinations with estradiol or norethindrone acetate can open ancillary revenue streams by enhancing patient compliance and expanding therapeutic labels.

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Emerging Trends and Future Outlook

Digital health integration, personalized medicine, and biomarker-driven therapies are gradually influencing the hormonal drug market, potentially increasing elagolix’s relevance. The rise of biosimilars post-patent expiry might reduce healthcare costs but also challenge current revenue streams.

Furthermore, increased R&D investments in non-invasive administration routes and reduced side effects could enhance market sustainability.

Conclusion

Elagolix sodium's market trajectory hinges on regulatory approvals for broader indications, competitive responses following patent expiry, and ongoing clinical innovations. While current growth prospects are favorable—anchored by expanding therapeutic applications and patient demand—long-term profitability mandates strategic adaptation to competitive pressures, cost management, and technological advancements.

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Key Takeaways

• Growing Demand: Rising prevalence of hormone-related conditions sustains demand for elagolix and similar therapies.
• Market Expansion Opportunities: Indications beyond endometriosis, like uterine fibroids, are poised for commercialization.
• Patent & Competition Risks: Imminent patent expiry opens doors for biosimilars and generics, potentially reducing revenues.
• Payers & Pricing: Reimbursement policies and value-based pricing strategies will influence market share.
• Innovation & R&D: Future growth will depend on pipeline success, including combination products and reduced side effect profiles.

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FAQs

1. When is the patent for elagolix expected to expire, and how will it influence the market?
The patent is projected to expire around 2026. This expiration will likely lead to an influx of biosimilars and generics, intensifying price competition and reducing brand-name sales.

2. What are the primary therapeutic indications for elagolix?
Elagolix is primarily approved for the management of endometriosis-associated pain, with potential expansion into uterine fibroids and other hormonally driven disorders.

3. How significant is the role of regulatory approvals in shaping elagolix’s financial future?
Regulatory decisions are critical; expanded indications and label updates can unlock new revenue streams, while delays or denials constrain growth.

4. What’s the outlook for estradiol and norethindrone acetate markets amid evolving healthcare policies?
Demand remains steady driven by HRT and contraceptive needs. However, pricing pressures and preferences for biosimilars could influence market shares.

5. How might ongoing research impact the future revenue of elagolix?
Clinical trials exploring new combinations and delivery methods could extend market relevance, augment revenues, and mitigate the impact of generic competition.

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References

[1] Global Endometriosis Market Analysis, MarketsandMarkets, 2022.
[2] IQVIA Reports, 2021.