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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 eleven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and three 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 three 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:	103
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	5
Patent Applications:	151
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
Stanford University	Phase 2
Wake Forest University Health Sciences	Phase 2
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 twelve 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	210450-002	Jul 23, 2018		RX	Yes	Yes	12,102,637		Y
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018		RX	Yes	No	11,707,464
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018		RX	Yes	No	10,682,351
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-002	Jul 23, 2018		RX	Yes	Yes	7,419,983		Y	Y

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	7,462,625
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	7,056,927
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018	7,462,625

International Patents for ORILISSA

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

Country	Patent Number	Title	Estimated Expiration
Japan	2016513708	月経出血過多および子宮類線維腫の処置に使用するための組成物
South Korea	20030012846
Australia	2021204104
European Patent Office	3668514	FORMULATIONS PHARMACEUTIQUES SOLIDES POUR LE TRAITEMENT DE L'ENDOMÉTRIOSE, DE FIBROMES UTÉRINS, DU SYNDROME DES OVAIRES POLYKYSTIQUES ET DE L'ADÉNOMYOSE (SOLID PHARMACEUTICAL FORMULATIONS FOR TREATING ENDOMETRIOSIS, UTERINE FIBROIDS, POLYCYSTIC OVARY SYNDROME AND ADENOMYOSIS)
Canada	2906894	COMPOSITIONS COMPRENANT DE L'ELAGOLIX A UTILISER DANS LE TRAITEMENT DE LA DOULEUR ASSOCIEE A L'ENDOMETRIOSE (COMPOSITIONS COMPRISING ELAGOLIX FOR USE IN TREATING PAIN ASSOCIATED WITH ENDOMETRIOSIS)

ORILISSA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Orilissa (Elagolix)

Introduction to Orilissa

Orilissa, also known as elagolix, is a groundbreaking medication developed by AbbVie for the management of endometriosis-associated pain. It is the first orally administered Gonadotropin-Releasing Hormone (GnRH) antagonist approved by the FDA, marking a significant advancement in the treatment of endometriosis.

Market Size and Growth

The endometriosis treatment market, within which Orilissa operates, is experiencing robust growth. As of 2022, the global endometriosis treatment market was valued at USD 1,222.2 million and is projected to expand at a compound annual growth rate (CAGR) of 13.5% from 2023 to 2030, reaching USD 3.2 billion by 2030[1].

Segment Performance

Hormone Therapy Segment

The hormone therapy segment, which includes Orilissa, is anticipated to witness a CAGR of 13.99% during the forecast period. This growth is driven by innovative therapeutic products such as AbbVie’s Orilissa and ObsEva’s Yselty (linzagolix)[1].

Route of Administration

Orilissa, being an oral medication, benefits from the dominance of the oral segment in the market. The oral route of administration accounted for a revenue share of 19.7% in 2022 and is expected to maintain its share due to its convenience and effectiveness[1].

Regional Growth

Asia Pacific

The Asia Pacific region is expected to witness a significant growth rate of 14.83% over the forecast period. This growth is attributed to the increasing number of disease cases and strategic initiatives by market players for regional expansion[1].

United States

The U.S. market will continue to be a major contributor, accounting for around 68% of all drug sales by 2030. However, the U.S. sales of Orilissa will be slightly tempered by generic erosion after its patent expires in 2024, with a patent term extension (PTE) filed for 2029[4].

Financial Performance of AbbVie

AbbVie, the manufacturer of Orilissa, has reported strong financial results. For the full year 2021, AbbVie delivered net revenues of $56.197 billion on a GAAP basis, an increase of 22.7% from the previous year. The adjusted diluted EPS increased by 20.3% to $12.70[2].

Competitive Landscape

The endometriosis treatment market is highly competitive, with several key players undertaking strategic initiatives such as new launches, collaborations, mergers, and acquisitions. AbbVie’s Orilissa competes with other notable treatments like ObsEva’s Yselty (linzagolix) and Myovant/Pfizer’s Relugolix combination tablet[1].

Clinical and Regulatory Aspects

Orilissa was approved by the FDA in 2018 and has since become a significant player in the endometriosis treatment market. The medication has undergone thorough clinical reviews, highlighting its efficacy and safety profile. For instance, the FDA's multi-disciplinary review noted the absence of clinically relevant food-drug or drug-drug interactions, ensuring appropriate management strategies[3].

Pipeline and Future Outlook

The approval of several pipeline agents during the 2020–2030 forecast period is expected to drive strong growth in the endometriosis market. While Orilissa’s patent expiration in 2024 may lead to generic competition, its current market position and the ongoing development of new treatments will continue to shape the market dynamics[4].

Strategic Collaborations

Strategic collaborations are crucial for market expansion. For example, ObsEva SA and Theramex entered into a strategic licensing agreement in February 2022 to expand linzagolix outside of the U.S., Canada, and Asia, which could influence the competitive landscape and growth opportunities for Orilissa[1].

Key Takeaways

• Market Growth: The endometriosis treatment market is expected to grow at a CAGR of 13.5% from 2023 to 2030.
• Segment Performance: The hormone therapy segment, including Orilissa, is expected to grow significantly.
• Regional Growth: Asia Pacific and the U.S. are key regions driving market growth.
• Financial Performance: AbbVie’s strong financial results indicate a robust foundation for Orilissa’s market presence.
• Competitive Landscape: The market is competitive, with several key players and new treatments emerging.

FAQs

Q: What is Orilissa, and how is it used in treating endometriosis? A: Orilissa, or elagolix, is an orally administered GnRH antagonist used to manage endometriosis-associated pain. It is the first FDA-approved oral GnRH antagonist for this condition.

Q: What is the projected market size for the endometriosis treatment market by 2030? A: The global endometriosis treatment market is expected to reach USD 3.2 billion by 2030, growing at a CAGR of 13.5% from 2023 to 2030[1].

Q: How does the oral route of administration impact Orilissa’s market share? A: The oral route of administration, which includes Orilissa, dominated the market in 2022 with a revenue share of 19.7% and is expected to maintain its share due to its convenience and effectiveness[1].

Q: What are the key regions driving the growth of the endometriosis treatment market? A: The Asia Pacific region and the U.S. are key drivers of market growth, with the Asia Pacific region expected to witness a growth rate of 14.83% over the forecast period[1].

Q: How will the patent expiration of Orilissa impact its market presence? A: The patent expiration of Orilissa in 2024 may lead to generic competition, which could slightly temper its U.S. sales. However, the medication’s current market position and ongoing developments in the field will continue to influence its market dynamics[4].

Sources

1. Grand View Research: Endometriosis Treatment Market Size & Trends Report, 2030.
2. AbbVie Investors: AbbVie Reports Full-Year and Fourth-Quarter 2021 Financial Results.
3. FDA: NDA Multi-Disciplinary Review and Evaluation for Orilissa (elagolix sodium).
4. Pharmaceutical Technology: Endometriosis market projected to grow at a CAGR of 10.6% from 2020 to 2030.