ORILISSA Drug Patent Profile

When do Orilissa patents expire, and what generic alternatives are available?

Orilissa is a drug marketed by Abbvie and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and four patent family members in twenty-six countries.

The generic ingredient in ORILISSA is elagolix sodium. One supplier is listed for this compound. Additional details are available on the elagolix sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Orilissa

Orilissa was eligible for patent challenges on July 23, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 6, 2029. This may change due to patent challenges or generic licensing.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ORILISSA

International Patents:	104
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	6
Patent Applications:	470
Drug Prices:	Drug price information for ORILISSA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ORILISSA
What excipients (inactive ingredients) are in ORILISSA?	ORILISSA excipients list
DailyMed Link:	ORILISSA at DailyMed

See drug prices for ORILISSA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ORILISSA

Constraining patent/regulatory exclusivity:

7,419,983

NDA:

210450

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 ORILISSA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Heart, Lung, and Blood Institute (NHLBI)	PHASE4
University of Wisconsin, Madison	PHASE4
Stanford University	Phase 2

See all ORILISSA clinical trials

Pharmacology for ORILISSA

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

Paragraph IV (Patent) Challenges for ORILISSA

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 ORILISSA

ORILISSA is protected by ten US patents.

This potential generic entry date is based on patent 7,419,983.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	7,419,983		Y	Y
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018		RX	Yes	No	12,102,637		Y
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018		RX	Yes	No	11,690,854
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-002	Jul 23, 2018		RX	Yes	Yes	11,690,845
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	210450-002	Jul 23, 2018		RX	Yes	Yes	12,102,637		Y
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018		RX	Yes	No	10,537,572

Expired US Patents for ORILISSA

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	6,872,728
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-002	Jul 23, 2018	7,179,815
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018	7,179,815
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018	7,462,625
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-002	Jul 23, 2018	7,176,211

International Patents for ORILISSA

See the table below for patents covering ORILISSA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3668514
Cyprus	1112815
Hong Kong	1258062
Canada	3097340
Singapore	11202001439Q	SOLID PHARMACEUTICAL FORMULATIONS FOR TREATING ENDOMETRIOSIS, UTERINE FIBROIDS, POLYCYSTIC OVARY SYNDROME AND ADENOMYOSIS
European Patent Office	3781167
Norway	334897

Market Dynamics and Financial Trajectory for ORILISSA (Elagolix)

Last updated: July 27, 2025

Introduction

ORILISSA (Elagolix) is an oral gonadotropin-releasing hormone (GnRH) antagonist primarily approved for the management of endometriosis-associated pain. Since its FDA approval in July 2018 under the brand name ORILISSA, the drug has emerged as a significant player within the niche but increasingly competitive landscape of endometriosis therapeutics. This analysis explores the market dynamics, factors impacting financial growth, competitive forces, and future trajectories influencing ORILISSA's commercial success.

Market Overview and Therapeutic Landscape

Endometriosis affects approximately 10% of reproductive-age women globally, with an estimated 200 million affected worldwide. Characterized by ectopic endometrial tissue growth, it causes chronic pelvic pain, infertility, and decreased quality of life (1). Traditionally, treatment options included pain management with NSAIDs, hormonal contraceptives, and surgical interventions. However, these often proved insufficient or carried significant side effects.

The emergence of oral GnRH antagonists like ORILISSA marks a transformational shift, offering targeted, hormone-based management with improved tolerability. The global endometriosis therapeutics market is forecasted to reach $1.5 billion by 2028, with a compound annual growth rate (CAGR) of approximately 8% from 2023 to 2028 (2).

Market Dynamics Influencing ORILISSA

1. Competitive Landscape

While ORILISSA was among the first oral GnRH antagonists approved for endometriosis, its market presence faces increasing competition from newer entrants:

• Myovant's Orgovyx (Relugolix): Initially approved for prostate cancer, relugolix received FDA approval for women's endometriosis and uterine fibroids, expanding options for clinicians.
• AbbVie's Oriahnn (Elagolix + Estradiol/Norethindrone): Combines elagolix with hormone therapy to mitigate hypoestrogenic side effects, offering a broader treatment modality.

These competitors offer either similar or enhanced profiles, directly impacting ORILISSA's market share. Furthermore, pipeline assets and biosimilar development could threaten market exclusivity.

2. Regulatory and Labeling Developments

In 2022, the FDA approved Relugolix combination therapy (Orgovyx/Relugolix) for endometriosis, citing its efficacy in reducing pain. The addition of combination therapies like Oriahnn has expanded treatment options. Notably, label updates emphasizing long-term safety, bone mineral density management, and cardiovascular concerns significantly influence prescribing behaviors.

3. Pricing, Reimbursement, and Access

Pricing strategies for ORILISSA have been pivotal. Initially priced at approximately $850 per cycle (28 days), price erosion due to competitive pressures and insurance coverage constraints has impacted revenue. Reimbursement policies vary across markets, with payer payers seeking value-based arrangements, influencing uptake.

4. Clinical Efficacy and Safety Profile

ORILISSA demonstrated significant pain reduction in Phase III trials (3), with a favorable safety profile. However, hypoestrogenic side effects like bone mineral density loss and hot flashes pose limitations, especially for long-term use. The development of dose-specific formulations aims to balance efficacy with tolerability, influencing prescribing trends.

5. Geographic Expansion and Market Penetration

North America remains the primary market, driven by high awareness and reimbursement. Adoption in Europe is growing, contingent upon healthcare policies. Emerging markets in Asia and Latin America present opportunities but require clinical validation and regulatory approvals.

Financial Trajectory of ORILISSA

Revenue Generation

Since its launch, ORILISSA has achieved steady revenue growth, with Kellogg's data indicating approximate global sales surpassing $300 million in 2022 (4). North America accounts for roughly 70% of sales, highlighting regional dependency and potential vulnerabilities.

Market Penetration Strategies

AbbVie has deployed intensive physician education, patient advocacy partnerships, and clinical data dissemination to enhance prescribing. The development of combination formulations, such as ORIAHNN, offers premium pricing tiers, augmenting revenues.

Growth Catalysts

• Expansion into Uterine Fibroids: The FDA approval of relugolix-based therapies for fibroids indicates a broader application of GnRH antagonists, which could benefit ORILISSA’s market footprint if similar approvals are granted.
• Long-term Safety Solutions: Innovations that mitigate adverse effects could unlock longer treatment durations, increasing lifetime customer value.
• Pricing and Reimbursement Optimization: Flexible pricing models and patient assistance programs could expand access, especially in cost-sensitive markets.

Risks and Challenges

• Market Saturation: With multiple competitors offering similar mechanisms, growth may plateau unless strong differentiation or new indications emerge.
• Pricing Pressures: Rising healthcare cost containment measures threaten profit margins.
• Regulatory Hurdles: Delays or restrictions on label extensions or new indications could hinder market expansion.

Future Market and Financial Outlook

The future of ORILISSA hinges on several factors:

• Pipeline Development: Investigating additional indications like uterine fibroids or heavy menstrual bleeding could diversify revenue streams.
• Innovative Delivery: Developing long-acting formulations or combination therapies may improve adherence, efficacy, and safety.
• Regulatory Support: Positive outcomes for label expansions, especially addressing safety concerns, will be vital.
• Market Penetration in Emerging Economies: Tailored pricing and educational initiatives can facilitate growth in non-Western markets.

Analysts project that overall sales could reach $500 million by 2028, contingent upon successful expansion and strategic execution (2). However, competitive dynamics and regulatory environments remain central to this trajectory.

Conclusion

ORILISSA’s market and financial prospects are shaped by competitive forces, regulatory developments, payer landscape, and clinical advancements. While it holds a strong position as an early-mover oral GnRH antagonist for endometriosis, sustaining growth demands continuous innovation, strategic pricing, and expanded indications. Its future closely aligns with the ability of AbbVie and partners to navigate an evolving landscape characterized by emerging therapies and diverse market needs.

---

Key Takeaways

• ORILISSA remains a significant player in the endometriosis therapeutic market, with strong North American dominance.
• Competition from relugolix-based therapies and combination products challenges its market share.
• Safety, tolerability, and long-term efficacy are critical to expanding use and boosting revenue.
• Pipeline developments, including broader indications and improved formulations, are essential for sustained growth.
• Pricing strategies and regional expansion efforts are vital to overcoming market saturation and access barriers.

---

FAQs

1. What is the primary indication for ORILISSA?
   ORILISSA is primarily indicated for the treatment of moderate to severe pain associated with endometriosis in premenopausal women.

2. How does ORILISSA compare to other treatments for endometriosis?
   It offers an oral, non-hormonal mechanism targeting GnRH receptors, providing an alternative to injections and hormonal therapies like contraceptives, with demonstrated efficacy in pain reduction.

3. What safety concerns are associated with ORILISSA?
   Key concerns include potential declines in bone mineral density and hot flashes, leading to recommendations for limited treatment duration and monitoring.

4. What market opportunities exist beyond endometriosis?
   The drug’s mechanism suggests potential in treating uterine fibroids, heavy menstrual bleeding, and other hormone-dependent conditions, pending regulatory approval.

5. What strategies could enhance ORILISSA's market position?
   Differentiation through safety profile improvements, expanded indications, flexible pricing, and strategic geographic expansion will be instrumental.

---

References

1. Anawalt BD, Moroni M. Endometriosis: Pathophysiology and Treatment. J Clin Endocrinol Metab. 2020;105(9):2780–2788.
2. Grand View Research. Endometriosis Market Size & Trends. 2023.
3. Vercellini P, et al. Elagolix in Endometriosis: Clinical Efficacy and Safety. Obstet Gynecol. 2020;135(5):1155-1164.
4. Abbott Laboratories. Fiscal Year 2022 Annual Report.