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 23, 2039. This may change due to patent challenges or generic licensing.

There have been seventeen 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:	401
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

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.

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			Y	Y
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018		RX	Yes	No			Y
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018		RX	Yes	No
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-002	Jul 23, 2018		RX	Yes	Yes
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018		RX	Yes	No			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
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	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

International Patents for ORILISSA

When does loss-of-exclusivity occur for ORILISSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

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

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

Country	Patent Number	Title	Estimated Expiration
Australia	2016317955
Australia	2021204104
Canada	3002791
European Patent Office	3344245
Hong Kong	1258062

ORILISSA market dynamics and financial trajectory: US sales, pricing pressure, payer trends, and exclusivity-driven generic/biosimilar risks

Last updated: June 12, 2026

Executive summary: ORILISSA (elagolix; oral GnRH receptor antagonist) has shifted from launch-driven growth to a late-cycle volume and price mix story marked by payer steering and competitive brand substitution within endometriosis treatment. Financial trajectory is now dominated by (1) oral GnRH antagonists and GnRH/LH-axis competitors expanding formulary presence, (2) contracting commercial headroom as class exposure normalizes, and (3) exclusivity and generic entry timing that determines near-term forecast risk.

What is ORILISSA (elagolix) and how is it positioned commercially?

ORILISSA is an oral GnRH receptor antagonist indicated for endometriosis. The core commercial positioning is convenience versus injectable GnRH analogs and reduced hypoestrogenic side effects compared with some earlier hormonal strategies, with dosing and duration constraints that create real-world prescriber workflow and payer utilization management.

What dosing regimens shape market access and persistence?

• ORILISSA is marketed in dosing regimens tied to treatment duration limits and symptom control needs.
• Real-world adherence is influenced by gastrointestinal tolerability and fatigue/hot-flash type adverse events typical of GnRH-axis suppression.
• Formulary committees often use prior authorization (PA) and step edits tied to documented endometriosis diagnosis and prior therapy history.

How do payers evaluate ORILISSA versus other endometriosis drugs?

Payers generally compare:

• Oral vs injectable administration convenience
• Total annual cost across therapy duration caps
• Safety profile considerations that affect utilization management
• Evidence depth in subpopulations (e.g., moderate-to-severe pain, adherence signals)

Because ORILISSA is not a biologic, it competes in a formulary band where generics and therapeutic switches within the class can materially compress net pricing.

How have ORILISSA sales trended financially in the US and what drives the direction?

Direct driver: ORILISSA revenue performance is a function of net price (after rebates) and volume penetration, both of which are constrained by endometriosis market dynamics and class competition.

What market dynamics explain late-cycle revenue compression?

1. Formulary normalization of GnRH-axis oral therapies

   • Endometriosis treatment formularies have broadened beyond older analogs.
   • As more options establish coverage, payer leverage increases and ORILISSA faces higher rebate pressure.

2. Payer utilization management reduces unrestricted prescribing

   • PA and step therapy reduce new prescriber starts and can slow conversion from alternative hormonal regimens.
   • Dose-and-duration limits translate into finite annual treatment periods, capping addressable patient-time.

3. Competitive substitution within the therapeutic class

   • Competitors that show comparable symptom control with differentiated safety or dosing schedules can win line-of-therapy decisions.

What KPIs typically indicate ORILISSA financial trajectory?

• Script starts and TRx growth rate (early cycle indicator)
• Persistence at 3, 6, and 12 months (late-cycle indicator)
• Net revenue per script (rebate pressure indicator)
• Share of paid claims in commercial plans (competitive access indicator)

Why does ORILISSA face pricing pressure and what are the payer levers that matter?

Answer: Net pricing pressure is driven by rebate intensity, PA/step edits that shift mix, and plan-level preference for competing endometriosis therapies.

Which payer levers most affect ORILISSA net revenue?

• Preferred tier placement versus non-preferred tier status
• Contracting with higher rebate demands during mid-to-late lifecycle
• Narrow criteria in PA forms that reduce eligible populations
• Specialty pharmacy routing and claims processing constraints

How does channel mix affect ORILISSA financial outcomes?

Endometriosis treatments often rely on specialty and pharmacy benefit management (PBM) workflows. Shifts in:

• Specialty pharmacy coverage
• Dispensing fees and reimbursement rules
• Patient assistance utilization
  can change net revenue even if gross demand remains stable.

What exclusivity timeline governs ORILISSA risk and when does it lose protection?

Answer: ORILISSA’s commercial forecast risk is tied to US patent and regulatory exclusivity (and the timing of any FDA-approved generic/authorized entry). Market dynamics are heavily sensitive to whether patent estates block an abbreviated pathway and whether exclusivity gaps exist by indication and formulation.

What to track for exclusivity-driven entry risk?

• Orange Book listing status for elagolix (active ingredient)
• Patent expiration dates by claim scope: composition-of-matter, formulation, and method-of-use
• Any settlement agreements tied to paragraph IV (if any) or authorized product launches
• Pediatric exclusivity and other regulatory exclusivities (if applicable)

What patents protect ORILISSA and how strong is the patent estate?

A full, decision-grade patent estate assessment requires Orange Book and docket-level specificity (US patents, claim coverage, expiration dates, assignee, and litigation posture). Without enumerated, citable patent numbers and their expiration schedules, a market and financial trajectory cannot be anchored to enforceability and entry timing with the necessary precision.

What generic entry risks exist for ORILISSA under Paragraph IV?

Answer: ORILISSA’s generic risk is determined by whether ANDA filers can carve around active-ingredient, dosage form, and method-of-use protection. Generic entry threat typically rises when the remaining enforceable patent set is narrow or scheduled to expire soon relative to commercial peak/brand lifecycle.

A complete Paragraph IV risk analysis requires:

• Confirmed ANDA filings and certifications (Paragraph IV vs other)
• Court filings and stay status (30-month stay, injunctions, settlements)
• Identified “trigger” patents and their current enforceability

Without those enumerated items, the entry-risk conclusion cannot be made with the required specificity.

How does ORILISSA compare with competing endometriosis drugs on market access and financial impact?

Answer: ORILISSA competes for formulary share in endometriosis through oral convenience and symptom control. Financial impact depends on whether competitors win preferred placement and whether payer controls shift to alternative agents.

How does ORILISSA stack up versus older hormonal standards?

Compared with GnRH analogs and other hormonal approaches:

• ORILISSA’s oral administration improves convenience but does not eliminate payer scrutiny
• Net pricing and rebate terms decide whether it stays preferred
• Duration limits shape patient-time treated per year

How does ORILISSA stack up versus newer oral options?

Against newer oral GnRH pathway competitors:

• Differentiation often reduces to net price, clinical endpoints in the payer-relevant population, and tolerability
• Formulary position tends to migrate to the lowest net cost per controlled symptom

What FDA regulatory status affects ORILISSA commercial trajectory?

Answer: FDA labeling and regulatory status impact utilization management through indication scope, dosing constraints, and safety warnings that shape PA criteria and prescriber comfort.

What matters for commercial and revenue forecasts?

• Label restrictions that limit eligible patients
• Safety-related contraindications that reduce willingness to prescribe
• Whether label supports broader patient adoption over time (expansion) or constrains it

A decision-grade forecast requires exact label history, but a citable regulatory timeline is not provided here.

What litigation and settlements could change ORILISSA revenues?

Answer: Patent litigation outcome and settlement terms determine whether generic entry is delayed or accelerated and whether authorized competitors launch at shared risk.

A full litigation impact analysis requires:

• Case captions, court, docket numbers
• Settlement agreement terms (entry date, supply limits, exclusivity carve-outs, design-around)
• Current status of any stays or injunctions

No citable litigation data is included in the information provided.

How to model ORILISSA revenue under generic entry scenarios?

Answer: Scenario modeling should treat ORILISSA revenue as a function of (1) timing of enforceable barriers, (2) probability of immediate entry versus delayed entry, and (3) expected price erosion magnitude after generic launch.

Scenario structure for late-cycle oral brands

• Base case: continued branded coverage with incremental share stabilization
• Upside: delayed entry due to patent/litigation or tighter generic carve-outs; stronger net price maintenance
• Downside: earlier entry with rapid price erosion and high payer switching

What variables usually drive switching intensity?

• Number of generic competitors and speed of market penetration
• PBM formulary behavior after entry
• Patient assistance discontinuation
• Any bioequivalence or formulation differences that affect perceived tolerability

A numerically calibrated model cannot be produced without ORILISSA sales history, unit volume, net price, and any confirmed entry catalysts.

Key Takeaways

• ORILISSA’s financial trajectory is now dominated by payer steering, net pricing pressure, and substitution dynamics within endometriosis therapeutics.
• Late-cycle revenue risk rises as enforceable patent and regulatory protection approaches critical thresholds.
• Generic entry and patent litigation outcomes are the primary swing factors for forecast deviations, but they require enumerated Orange Book listings, patent expiration data, and litigation/sanction timelines to quantify.
• Without citable, claim-level patent and regulatory event data, a decision-grade exclusivity, entry-risk, and revenue-scenario forecast cannot be completed.

FAQs

1) When did ORILISSA launch and how did uptake progress in early years?

2) What is ORILISSA’s typical prior authorization criteria in major US payer plans?

3) How do net prices for ORILISSA change after formulary contract renegotiations?

4) What endometriosis competitors most often replace ORILISSA at the pharmacy counter?

5) What factors determine how fast patients switch after an ORILISSA generic launch?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (search elagolix/ORILISSA). FDA.
2. FDA Labeling for ORILISSA (elagolix). US Food and Drug Administration.

DrugChatter Q&A for ORILISSA

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