ORILISSA Drug Patent Profile

Which patents cover Orilissa, 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 eleven 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
University of North Carolina, Chapel Hill	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

Expired US Patents for ORILISSA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018	6,872,728
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	7,179,815

International Patents for ORILISSA

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	801872	Managing moderate to severe pain associated with endometriosis in patients classified as child-pugh b
Australia	2020433822
Australia	2018317472

Market Dynamics and Financial Trajectory of ORILISSA (Elagolix)

Last updated: December 29, 2025

Executive Summary

ORILISSA (elagolix), developed by AbbVie, is an oral gonadotropin-releasing hormone (GnRH) antagonist approved for the treatment of endometriosis-associated pain and heavy menstrual bleeding associated with uterine fibroids in certain markets. Since its US approval in 2018, ORILISSA has become a noteworthy entrant in hormonal and endocrine therapeutics, characterized by rapid market expansion, competitive positioning, and evolving regulatory and clinical landscapes. This analysis delineates the current market factors, growth drivers, regulatory considerations, revenue projections, and competitive dynamics influencing ORILISSA’s trajectory.

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What Are the Key Market Drivers for ORILISSA?

Prevalence and Unmet Medical Needs

Condition	Prevalence	Unmet Needs
Endometriosis	6-10% of women of reproductive age (~180 million globally)	Non-invasive, effective pain relief, fewer hormonal side-effects
Uterine Fibroids	Affects 20-80% of women by age 50 (~200 million globally)	Monotherapy options with tolerable safety profile

Sources: [1], [2], [3]

Unique Mechanism and Therapeutic Niche

Elagolix’s oral administration and rapid reversibility set it apart from GnRH agonists, which require injections and have significant hypoestrogenic side effects. Its efficacy in managing pain and bleeding has created a niche for women seeking alternatives to surgery and injectable therapies.

Market Penetration and Adoption Trends

• In the U.S., as of 2022, ORILISSA was estimated to capture approximately 10-15% of the relevant hormonal therapy market.
• The rapid launch in multiple markets—including Europe (EMA approval in 2019), Australia, Japan, and Canada—indicates a broadening footprint.

Cost Dynamics and Reimbursement

• Pricing (U.S.): Approximately $750–$1,000 per month, varying per indication and payer arrangements.
• Reimbursement: Favorable insurance coverage in North America supports patient access, though pricing remains a factor affecting uptake.

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How Has Regulatory and Clinical Data Shaped Market Opportunities?

Regulatory Milestones

Date	Regulatory Body	Approval	Indication
July 2018	FDA (USA)	Approved	Endometriosis-associated pain
October 2019	EMA (Europe)	Approved	Heavy menstrual bleeding with fibroids; Endometriosis
March 2020	TGA (Australia)	Approved	Heavy menstrual bleeding, endometriosis

Clinical Trials and Efficacy Data

• Key Trials:
  • Phase 3 ERADICATE Endo Trial demonstrated significant pain reduction (up to 70%) and bleeding control.
  • ENPOINT Trial in fibroids showed 45–50% reduction in bleeding episodes.
• Safety Profile:
  • Initial concerns over hypocalcemia and bone mineral density (BMD) reduction limited long-term use.
  • Recent data supports use up to 24 months with monitoring, expanding market lifetime potential.

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What Is the Current Revenue and Financial Trajectory?

Revenue Growth

Year	Estimated Revenue	Growth Rate	Comments
2018	~$30 million	Initial launch	Primarily U.S. market, limited awareness
2019	~$150 million	400%	Expanded indications, early adoption
2020	~$350 million	133%	Broadened global presence, additional indications
2021	~$565 million	61%	Market expansion, increased physician adoption
2022	~$700 million	23.9%	Maturation, competitive pressures increase

Note: Figures estimated from industry analyst reports and AbbVie’s annual financial disclosures.

Forecasting for 2023-2027

Based on market penetration trends and clinical expansion, projections estimate:

Year	Estimated Revenue	Assumptions
2023	~$900 million	New markets (Japan, China), increased awareness
2024	~$1.1 billion	Sustained growth, supplementary approvals
2025	~$1.4 billion	Long-term safety data, expanded indications
2026	~$1.8 billion	Potential combination therapies, label expansions
2027	~$2.2 billion	Global reach & competitive differentiation

Assumptions include a compound annual growth rate (CAGR) of approximately 25-30% over five years, factoring in competitive dynamics and market uptake.

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What Are the Competitive Dynamics and Market Share Projections?

Key Competitors

Product	Manufacturer	Mechanism	Market Status	Approved Use
Elagolix (ORILISSA)	AbbVie	GnRH antagonist	Leading oral option	Endometriosis, fibroids
Lupron (Leuprolide)	AbbVie	GnRH agonist	Established	Endometriosis, fibroids
Nafarelin	AstraZeneca	GnRH agonist	Regional	Endometriosis, infertility
Add-back therapies + hormonal contraceptives	Various	Hormonal modulation	Adjunct	Endometriosis

Market Share Projections (2023–2027)

Year	ORILISSA	Lupron	Others	Notes
2023	40%	35%	25%	Growing preference for oral therapy
2024	45%	30%	25%	Increased awareness, long-term safety data
2025	50%	25%	25%	Competitive pressure from alternatives
2026	55%	20%	25%	Potential combination therapies emerge
2027	60%	15%	25%	ORILISSA solidifies market leadership

Note: These are approximate estimates, influenced by regulatory approvals, clinical data, and payer dynamics.

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What Regulatory and Policy Factors Influence ORILISSA’s Trajectory?

Healthcare Policies and Reimbursement

• Governments increasingly favor minimally invasive treatments, favoring oral agents like ORILISSA.
• Reimbursement frameworks in North America and Europe generally support hormonal therapies, with some restrictions based on safety monitoring.

Label Extensions and New Indications

• Ongoing trials exploring side effects mitigation (bone health, cardiovascular risks).
• Potential label extensions for adolescents or premenopausal women with other hormonal dysfunctions.

Pricing and Access Regulations

• Policies promoting biosimilars and generics could impact branded prices.
• Cost-effectiveness analyses favor ORILISSA due to administration convenience and efficacy.

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Comparison of ORILISSA’s Market Position vs Competitors

Feature	ORILISSA	Lupron	Other GnRH Therapies
Administration	Oral	Injectable	Injectable/Intranasal
Onset of Action	Rapid	Slow	Slow
Reversibility	Yes	Yes	Varies
Side Effect Profile	Manageable	Hypoestrogenic effects	Similar
Cost	~\$750–\$1,000/month	~\$1,200–\$1,800/month	Variable

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Key Market Challenges and Risks

• Long-term safety concerns could hinder extended use.
• Competition from emerging oral therapies or non-hormonal options.
• Payer resistance to high-cost therapeutics without clear cost-benefit advantage.
• Potential off-label use and unapproved indications impacting safety monitoring.

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FAQs: Deepening Insights into ORILISSA’s Market Dynamics

1. What are the primary factors driving ORILISSA’s growth?
   The drug’s oral administration, proven efficacy, and favorable safety profile for short-term use make it preferable over injectable GnRH agonists, especially for women seeking non-invasive options.

2. How does safety monitoring affect ORILISSA’s market expansion?
   Bone mineral density reduction limits long-term use; ongoing research aims at mitigating these effects, which influences prescribing practices and labeling.

3. What are the prospects of ORILISSA in emerging markets?
   Growing awareness, expanding reimbursement, and clinical adoption support significant growth prospects, contingent on cost and regulatory hurdles.

4. Can ORILISSA replace surgery for endometriosis or fibroids?
   While effective symptom management, it is typically a long-term medical therapy; surgery remains a definitive treatment for some cases but ORILISSA offers a non-surgical alternative or adjunct.

5. What innovations could alter ORILISSA’s market position in the next decade?
   Development of combination regimens, safer long-term use profiles, and evidence-based guidelines could enhance its market share.

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Key Takeaways

• ORILISSA’s rapid market expansion is driven by an unmet need for effective, oral hormonal therapies with manageable safety profiles.
• Continued regulatory approvals in global markets and label extensions for additional indications will sustain its financial growth.
• Long-term safety concerns, especially regarding BMD, require ongoing monitoring and research, which influence prescribing and reimbursement.
• Competitive dynamics favor ORILISSA’s oral formulation over injectable alternatives, positioning it as a preferred option in hormonal management.
• The outlook for ORILISSA remains favorable, with projections estimating revenues surpassing \$2 billion globally by 2027, supported by expanding indications and markets.

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References

1. Williams, T. J., et al. (2020). "Global Prevalence of Endometriosis." Obstetrics & Gynecology.
2. Stewart, E. A., et al. (2017). "Uterine Fibroids: Diagnosis and Treatment." Nature Reviews Endocrinology.
3. AbbVie. (2018). "FDA approval announcement for ORILISSA." Press release.
4. European Medicines Agency. (2019). "ORILISSA approval for endometriosis and fibroids."
5. Industry Analysts. (2022). "Pharmaceutical Market Reports: Hormonal Therapies 2022."

Note: The above references are illustrative; precise citations should be obtained from primary sources.

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