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
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes			Y	Y

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
Japan	2023516404
China	111246850
Brazil	PI0412314	derivados de pirimidina-2,4-diona como antagonistas de receptor de hormÈnio liberador de gonadotropina

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

Last updated: February 13, 2026

Elagolix sodium combined with estradiol and norethindrone acetate is marketed primarily under the brand name Oriahnn, targeting endometriosis-associated pain. The product’s commercial performance and market prospects depend on regulatory approvals, competitive landscape, and shifting healthcare policies.

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Regulatory and Market Approval Status

• Elagolix sodium is an orally bioavailable gonadotropin-releasing hormone (GnRH) antagonist. It was approved by the FDA in 2018 for heavy menstrual bleeding associated with uterine fibroids (sold as Orilissa for endometriosis pain and Oriahnn specifically for endometriosis-related bleeding). Its combination with estradiol and norethindrone acetate received FDA approval in 2022 (publicly available filings).

• The combined formulation's approval was driven by the need for a therapeutic option with a favorable safety profile, addressing hormonal fluctuations induced by GnRH antagonists while providing concurrent estrogen and progestin support.

• Regulatory landscape remains active; approvals are primarily concentrated in the US, with ongoing evaluations in Europe and other markets.

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Market Size and Growth Drivers

• Endometriosis Treatment Market was valued at approximately $1.4 billion in 2022 (source: IQVIA), with projections to reach $2 billion by 2028, compound annual growth rate (CAGR) circa 7-8%.

• Key growth drivers: Increasing diagnosis rates, limited treatment options, patient preference for oral medications, and expanding insurance coverage.

• Oriahnn’s niche: Marketed for women with moderate to severe endometriosis-associated pain who require a non-surgical, oral hormonal therapy.

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Competitive Landscape

Key Products/Competitors	Mode of Action	Market Share (2022)	Notes
Leuprorelin (Lupron)	GnRH agonist	45%	Injectable, with higher side-effect profile
Norethindrone, Dienogest	Progestins	20%	Oral, long-standing use
Elagolix-based products	GnRH antagonist	15%	Growing due to oral administration
Others (Combipatch, Danazol)	Hormonal agents	20%	Varied indications, limited growth potential

• Elagolix’s competitive advantage lies in its oral delivery and dose flexibility. However, the cost and side-effect profile influence prescribing patterns.

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Financial Trajectory and Commercial Outlook

• Revenue performance (2022-2023): Data indicates initial sales in the low hundreds of millions USD, with steady growth expected.

• Pricing: Oriahnn typically sells for approximately $1,200-$1,500 per month depending on insurance coverage, with discounts and patient assistance programs in place.

• Sales projections: Assuming achieved sales of $120 million in 2022, with steady annual growth of 15-20%, revenues could approach $250-$300 million by 2026.

• Market expansion strategies: Focus on increasing awareness, expanding FDA-approved indications, and leveraging partnerships to penetrate broader markets.

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Key Factors Influencing Financial Performance

• Regulatory approval in key markets: Extended approvals or new indications can significantly boost revenues.

• Patent exclusivity: Elagolix’s primary patent expired or is nearing expiry, risking generic entry potentially by 2028.

• Pricing pressures: Payers seeking cost-effective alternatives could impact revenue. Premium pricing depends on differentiation from generic hormonal therapies.

• Patient adherence: Oral administration favors compliance but side effects like hot flashes and bone density loss may limit usage.

• Pipeline developments: New formulations, dose adjustments, or combination therapies can improve market share.

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Financial Risks and Opportunities

• Risks: Patent expiry, emerging competitors, reimbursement challenges, adverse event profile and safety concerns.

• Opportunities: Expanding indications, combination therapies, and potential approval for other hormonally driven conditions.

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Conclusion

The financial trajectory of elagolix sodium, especially in combination with estradiol and norethindrone acetate, is cautiously optimistic. Growth is driven by increased diagnosis rates of endometriosis, favorable administration routes, and the unmet need for oral therapies. Market share remains limited versus long-established injections but has growth potential amid expanding indications and geographic reach. Financial success hinges on regulatory milestones, patent protections, pricing, and competitive positioning.

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Key Takeaways

• Elagolix sodium combined with estradiol and norethindrone acetate is a targeted therapy for endometriosis, with scalable market potential.
• The market is competitive, dominated by injectable GnRH agonists, but orals like elagolix are gaining ground.
• Revenue projections indicate steady growth, potentially reaching $250 million by 2026, contingent on market expansion and regulatory progress.
• Patent expiration and generic competition pose risks; pipeline and indication expansion are strategic opportunities.
• Cost and safety profiles remain critical in influencing payer and patient adoption.

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FAQs

1. What conditions does elagolix sodium target?
   Primarily endometriosis-associated pain and heavy menstrual bleeding related to uterine fibroids.

2. How does elagolix compare to GnRH agonists?
   It offers an oral, reversible approach with potentially fewer side effects and improved patient adherence.

3. What is the main revenue driver for elagolix products?
   Market penetration in endometriosis treatment, payor coverage, and expanding indications.

4. When is patent expiry likely?
   Expected around 2028, opening opportunities for generics.

5. What are the primary risks to financial growth?
   Patent expiration, safety concerns, reimbursement limitations, and increased competition.

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References

[1] IQVIA. Market Analysis. 2022.
[2] FDA. Drug Approvals and Labeling. 2022.
[3] EvaluatePharma. Endometriosis Drug Market Forecast. 2022.
[4] Company filings. Annual Reports and investor presentations.