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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Elagolix sodium,estradiol,norethindrone acetate; elagolix sodium has ninety-eight 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:	98
US Patents:	8
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
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
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

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
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
Croatia	P20080646
South Korea	20200109291	자궁내막증, 자궁섬유증, 다낭난소증후군 또는 샘근육증을 치료하기 위한 약제학적 제형
Japan	2021531236	重度の月経出血を治療する方法
Japan	7374885
Norway	20056251

ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM Market Analysis and Financial Projection Experimental

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

Introduction

Elagolix sodium, combined with estradiol and norethindrone acetate, marketed as ORIAHNN, has revolutionized the treatment of heavy menstrual bleeding associated with uterine fibroids. This article delves into the market dynamics and financial trajectory of this drug, highlighting its efficacy, market positioning, and future projections.

Market Need and Efficacy

The drug addresses a significant unmet need in the treatment of uterine fibroids, a condition affecting millions of women worldwide. Clinical trials, such as the ELARIS-UF I and II trials, have demonstrated that elagolix sodium reduces menstrual blood loss significantly, with 68.5% and 76.2% of patients experiencing a clinically significant reduction in menstrual blood loss[3].

Market Positioning

ORIAHNN enters a market where existing treatments often have limitations, such as surgical interventions or less effective pharmacological options. Its unique mechanism of action, combining elagolix sodium, estradiol, and norethindrone acetate, positions it as a preferred choice for managing heavy menstrual bleeding associated with uterine fibroids. This combination offers a comprehensive approach, reducing menstrual bleeding and in some cases eliminating periods altogether, making it an attractive option for both patients and healthcare providers[2].

Competitive Landscape

The competitive landscape for treatments of uterine fibroids is evolving, with ORIAHNN competing against surgical options, other pharmacological treatments, and emerging therapies. However, its efficacy, convenience of use (with two capsules taken daily), and the comprehensive approach it offers give it a competitive edge. Despite the presence of direct competitors like Esmya (from Gideon Richter), ORIAHNN's unique combination and strong clinical outcomes set it apart[2][3].

Pricing and Cost Considerations

The cost of ORIAHNN is a critical factor in its market dynamics. While the exact pricing may vary, it is generally expected to be competitive with other treatments for uterine fibroids. The cost-benefit analysis favors ORIAHNN due to its high efficacy and the potential to reduce long-term healthcare costs associated with managing heavy menstrual bleeding[2].

Regulatory and Post-Marketing Surveillance

The FDA has mandated post-marketing surveillance studies to further assess the safety profile of ORIAHNN, particularly regarding side effects like alopecia and thrombotic events. These studies will provide valuable data on the long-term safety and efficacy of the drug, influencing its market dynamics and financial trajectory[2].

Financial Trajectory

Revenue Projections

Given its efficacy and significant market need, ORIAHNN is expected to generate substantial revenue. The drug's approval and subsequent market entry have positioned it as a major player in the treatment of heavy menstrual bleeding associated with uterine fibroids. Revenue projections are optimistic, especially as the drug gains traction and becomes a standard treatment option. Sales forecasts for elagolix sodium have risen, with projections indicating it could reach blockbuster status, exceeding $1.358 billion by 2022[3].

Market Share

ORIAHNN's unique mechanism of action and strong clinical outcomes are expected to help it capture a significant market share. As more healthcare providers and patients become aware of its benefits, the drug is likely to displace some existing treatments, further solidifying its market position[2].

Global Market Size and Growth

The global elagolix sodium market is valued at USD 100 billion in 2023 and is expected to reach USD 194.87 billion by 2031, growing at a 10% CAGR from 2024 to 2031. This growth is driven by the rising incidence of reproductive health conditions like endometriosis and uterine fibroids, improvements in the healthcare system, and growing public awareness of women's health issues[4].

Drivers of Market Growth

• Effectiveness in Treating Conditions: Elagolix sodium's demonstrated effectiveness in treating endometriosis and uterine fibroids-related pain and discomfort is a primary driver of market growth.
• Innovative Therapies: The growing use of innovative therapies by patients and healthcare professionals seeking alternatives to traditional treatments is another key factor.
• Regulatory Clearances and Reimbursement Schemes: Favorable regulatory clearances and reimbursement schemes are facilitating greater market penetration.
• Technological Developments: Improvements in drug delivery systems are enhancing treatment outcomes and patient compliance.
• Strategic Alliances: Strategic alliances between pharmaceutical companies and academic institutions for clinical studies and product development are also driving growth[4].

Challenges and Restraints

• Patent Litigation: The drug faces patent litigation, which could impact its market dynamics. However, 63% of patent challenges are decided in favor of the generic patent challenger, and 54% of successful challengers promptly launch generic drugs[2].
• Side Effects: Notable side effects such as alopecia, thrombotic events, and bone loss require careful management and ongoing post-marketing surveillance[2].

Geographical Segmentation

The market for elagolix sodium is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region presents unique opportunities and challenges, with varying levels of market penetration and regulatory environments[4].

Key Players and Market Competition

AbbVie Inc. is the primary player in the market for ORIAHNN, but the landscape is competitive with other pharmaceutical companies developing treatments for uterine fibroids and endometriosis. The competitive edge of ORIAHNN lies in its unique combination of active ingredients and strong clinical evidence[2][3].

Future Outlook

The future outlook for elagolix sodium, estradiol, and norethindrone acetate is promising. With ongoing post-marketing surveillance and the potential for expanded indications, the drug is poised to continue its robust growth. The global market's expansion, driven by increasing demand for effective treatments for reproductive health conditions, further solidifies the drug's position in the market.

Key Takeaways

• Efficacy: ORIAHNN is highly effective in reducing heavy menstrual bleeding associated with uterine fibroids.
• Market Need: The drug addresses a significant unmet need in the treatment of uterine fibroids.
• Side Effects: Careful management of side effects like alopecia and thrombotic events is necessary.
• Financial Trajectory: Expected to generate substantial revenue and capture a significant market share.
• Regulatory Surveillance: Ongoing post-marketing studies to assess long-term safety and efficacy.

FAQs

What is the primary indication for ORIAHNN?

ORIAHNN is primarily indicated for the management of heavy menstrual bleeding associated with uterine fibroids.

How effective is ORIAHNN in reducing menstrual bleeding?

Clinical trials have shown that ORIAHNN reduces menstrual blood loss significantly, with 68.5% and 76.2% of patients experiencing a clinically significant reduction in menstrual blood loss[3].

What are the key components of ORIAHNN?

ORIAHNN is a combination of elagolix sodium, estradiol, and norethindrone acetate.

What are the potential side effects of ORIAHNN?

Notable side effects include alopecia, thrombotic events, and bone loss[2].

What is the projected market size for elagolix sodium by 2031?

The global elagolix sodium market is expected to reach USD 194.87 billion by 2031, growing at a 10% CAGR from 2024 to 2031[4].

Sources

1. Market Research Intellect: Global Pharmaceutical Grade Elagolix Sodium Market Size, Trends ...
2. Drug Patent Watch: ORIAHNN (COPACKAGED) Patents and Market Positioning
3. Clarivate: Sales forecasts rise for AbbVie’s elagolix following expected approval in endometriosis
4. Market Research Intellect: Elagolix Sodium Market Size, Global Trends | Forecast 2024-2031
5. FDA: ORIAHNN (elagolix sodium, estradiol, norethindrone acetate) - NDA Approval and Labeling