Elagolix sodium - Generic Drug Details

What are the generic 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 fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for elagolix sodium

International Patents:	103
US Patents:	15
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	8
Patent Applications:	106
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			Y	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
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-002	Jul 23, 2018		RX	Yes	Yes			Y
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			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
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
Taiwan	201919632	Pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis
Australia	2021204104
Brazil	112020021276	métodos de tratamento de sangramento menstrual intenso
Mexico	2023002449	FORMULACIONES FARMACEUTICAS SOLIDAS PARA TRATAR LA ENDOMETRIOSIS, LOS FIBROMAS UTERINOS, EL SINDROME DE OVARIO POLIQUISTICO Y LA ADENOMIOSIS. (SOLID PHARMACEUTICAL FORMULATIONS FOR TREATING ENDOMETRIOSIS, UTERINE FIBROIDS, POLYCYSTIC OVARY SYNDROME AND ADENOMYOSIS.)
China	111246850
Norway	20056251

Elagolix sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Elagolix Sodium

Introduction

Elagolix sodium, a gonadotropin-releasing hormone (GnRH) receptor antagonist, has been making significant waves in the pharmaceutical industry, particularly in the treatment of endometriosis and heavy menstrual bleeding associated with uterine fibroids. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Growth and Projections

The global market for pharmaceutical-grade elagolix sodium has experienced a substantial surge in recent years and is projected to continue this upward trend. From 2023 to 2031, the market is expected to see robust growth, driven by increasing demand for effective treatments for endometriosis and uterine fibroids[1][4].

Market Segmentation

The market is segmented based on type (purity ≥99% and purity <99%) and application (tablets and others), as well as geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. This segmentation helps in understanding the diverse market dynamics and identifying key growth areas[1].

Key Drivers and Restraints

• Drivers: The market is driven by the increasing prevalence of endometriosis and uterine fibroids, the efficacy of elagolix sodium in reducing menstrual bleeding, and its unique mechanism of action. Additionally, the drug's ability to offer a non-surgical treatment option enhances its appeal[2][3].
• Restraints: Despite its benefits, the market faces challenges such as potential side effects (e.g., alopecia, changes in lipid parameters), regulatory requirements for post-marketing surveillance, and patent litigation that could impact generic launches[2][5].

Competitive Landscape

Elagolix sodium, particularly in its copackaged form as ORIAHNN (combining elagolix, estradiol, and norethindrone acetate), enters a competitive market where existing treatments may have limitations. ORIAHNN's unique formulation and strong clinical outcomes position it as a preferred choice, likely to capture a significant market share and displace some existing treatments[3].

Pricing and Cost Considerations

The pricing of elagolix sodium and ORIAHNN is competitive with other treatments for uterine fibroids. The cost-benefit analysis favors these drugs due to their high efficacy and potential to reduce long-term healthcare costs associated with managing heavy menstrual bleeding[3].

Financial Trajectory

• Revenue Projections: Given its efficacy and significant market need, elagolix sodium and ORIAHNN are expected to generate substantial revenue. The global Elagolix Sodium API market is projected to grow from approximately $1.4 billion in 2023 to $2.9 billion by 2032[4].
• 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 solidify its market position[3].

Regulatory and Post-Marketing Surveillance

The FDA has mandated post-marketing surveillance studies to further assess the safety profile of ORIAHNN, particularly regarding potential side effects like alopecia. These studies will provide valuable data that can influence the drug's market dynamics and financial trajectory[3][5].

Patient and Provider Adoption

Patient and provider adoption are crucial for the financial success of elagolix sodium and ORIAHNN. Positive word-of-mouth, favorable clinical outcomes, and educational campaigns by the manufacturer can drive adoption rates. Reimbursement policies and insurance coverage will also play a significant role in making the drug accessible to a broader patient population[3].

Industry Players and Market Entry

Key companies such as AbbVie Inc., Sun Pharmaceutical Industries Ltd, Hetero Labs Ltd, and others are profiled in market reports, highlighting their market entry, product offerings, and various market-related factors. These companies are instrumental in driving the market forward through their research, development, and marketing efforts[1].

Clinical Outcomes and Efficacy

Elagolix sodium has demonstrated significant efficacy in clinical trials, particularly in reducing menstrual bleeding and managing symptoms associated with endometriosis and uterine fibroids. The drug's ability to reduce menstrual bleeding significantly, and in some cases eliminate periods altogether, makes it an attractive option for both patients and healthcare providers[2][5].

Challenges and Opportunities

• Challenges: The market faces challenges such as patent litigation, potential side effects, and regulatory requirements. However, these challenges also present opportunities for innovation and differentiation.
• Opportunities: The growing demand for non-surgical treatments and the drug's unique mechanism of action present significant opportunities for market expansion and financial growth[1][3].

Global Market Outlook

The global market for elagolix sodium is expected to expand significantly, driven by increasing demand in various geographical regions. The market outlook is positive, with robust growth rates anticipated over the forecast period[1][4].

Key Takeaways

• The market for pharmaceutical-grade elagolix sodium is experiencing robust growth driven by its efficacy in treating endometriosis and uterine fibroids.
• ORIAHNN, the copackaged form of elagolix sodium, is poised to capture a significant market share due to its unique formulation and strong clinical outcomes.
• Regulatory and post-marketing surveillance studies are crucial for the long-term success of the drug.
• Patient and provider adoption, driven by positive clinical outcomes and educational campaigns, will be key to the drug's financial success.
• The global market is expected to grow substantially, reaching $2.9 billion by 2032.

Frequently Asked Questions

1. What is elagolix sodium used for?

Elagolix sodium is used for the treatment of endometriosis and heavy menstrual bleeding associated with uterine fibroids. It works as a gonadotropin-releasing hormone (GnRH) receptor antagonist.

2. What is ORIAHNN, and how does it differ from elagolix sodium?

ORIAHNN is a copackaged form of elagolix sodium that combines elagolix with estradiol and norethindrone acetate. This formulation is specifically designed to manage heavy menstrual bleeding associated with uterine fibroids and offers a comprehensive approach to treatment.

3. What are the key drivers of the elagolix sodium market?

The key drivers include the increasing prevalence of endometriosis and uterine fibroids, the drug's efficacy in reducing menstrual bleeding, and its unique mechanism of action.

4. What are the potential side effects of elagolix sodium?

Potential side effects include alopecia, changes in lipid parameters, and other adverse reactions such as shifts in LDL-C and triglycerides.

5. What is the projected market size for elagolix sodium by 2032?

The global Elagolix Sodium API market is projected to grow to approximately $2.9 billion by 2032[4].

Cited Sources:

1. Market Research Intellect: Global Pharmaceutical Grade Elagolix Sodium Market Size, Trends ...
2. FDA: NDA Multi‐Disciplinary Review and Evaluation {NDA 210450} {Orilissa and elagolix sodium}
3. Drug Patent Watch: When will the ORIAHNN (COPACKAGED) patents expire, and when ...
4. DataIntelo: Elagolix Sodium API Market Research Report 2032
5. FDA: NDA Multi‐Disciplinary Review and Evaluation {NDA 213388}