INLURIYO Drug Patent Profile

Which patents cover Inluriyo, and what generic alternatives are available?

Inluriyo is a drug marketed by Eli Lilly And Co and is included in one NDA. There are two patents protecting this drug.

This drug has ninety-six patent family members in thirty-seven countries.

The generic ingredient in INLURIYO is imlunestrant tosylate. One supplier is listed for this compound. Additional details are available on the imlunestrant tosylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Inluriyo

Inluriyo will be eligible for patent challenges on September 25, 2029. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 25, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for INLURIYO

International Patents:	96
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in INLURIYO?	INLURIYO excipients list
DailyMed Link:	INLURIYO at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

218881

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.

US Patents and Regulatory Information for INLURIYO

INLURIYO is protected by two US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Eli Lilly And Co	INLURIYO	imlunestrant tosylate	TABLET;ORAL	218881-001	Sep 25, 2025		RX	Yes	Yes			Y	Y
Eli Lilly And Co	INLURIYO	imlunestrant tosylate	TABLET;ORAL	218881-001	Sep 25, 2025		RX	Yes	Yes			Y	Y
Eli Lilly And Co	INLURIYO	imlunestrant tosylate	TABLET;ORAL	218881-001	Sep 25, 2025		RX	Yes	Yes

International Patents for INLURIYO

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

Country	Patent Number	Title	Estimated Expiration
Croatia	P20230009
European Patent Office	4155310
Canada	3105491
Portugal	3820873
Japan	2022037102

Market Dynamics and Financial Trajectory for INLURIYO: An In-Depth Analysis

Last updated: November 28, 2025

Executive Summary

INLURIYO (commercial name pending approval) is a novel therapeutic agent targeting [indication—e.g., autoimmune diseases, oncology, CNS disorders]. Positioned within a competitive landscape, its market viability hinges on regulatory milestones, clinical efficacy, manufacturing scalability, and market access strategies. This report comprehensively assesses the current market environment, forecasts financial trajectories, and identifies key drivers and challenges shaping INLURIYO’s commercial prospects.

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What Is INLURIYO?

INLURIYO is a [drug class, e.g., monoclonal antibody, small molecule, biologic], developed by [company name] for [specific medical condition]. It entered [clinical phase—e.g., Phase III] trials in [year], with expected regulatory submission in [year]. Its mechanism of action involves [brief description], aimed at [clinical benefit—e.g., immunomodulation, tumor suppression].

Key Attributes:

Attribute	Details
Drug class	[e.g., monoclonal antibody, small molecule]
Target indication	[e.g., rheumatoid arthritis]
Phase of development	[e.g., Phase III]
Anticipated launch date	[year]
Pricing strategy	[Premium, value-based, competitive]
Market size (global)	[e.g., $X billion] (estimated)

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What Are the Market Drivers for INLURIYO?

1. Growing Prevalence of Target Diseases

The burden of [indication] is intensifying globally. For instance, rheumatoid arthritis affects approximately e.g., 0.5-1% of the population worldwide, translating to [number] patients. This escalation propels demand for innovative therapeutics.

2. Regulatory Trends and Accelerated Approvals

Regulatory agencies such as FDA and EMA have prioritized treatments demonstrating substantial unmet needs. Fast-track designations and priority review pathways can abbreviate approval timelines by 6-12 months, expediting revenue realization.

3. Advancements in Biomarkers and Personalized Medicine

Biomarker-driven patient stratification enhances treatment efficacy, increasing market penetration and reimbursement potential.

4. Competitive Landscape Expansion

The pipeline for [indication] has expanded, with [X] pipeline drugs in phase III, underscoring the need for differentiators like superior efficacy, safety, or delivery methods.

5. Pricing and Reimbursement Policies

Countries like the US and EU are adopting value-based pricing models, emphasizing clinical benefits and cost-effectiveness, which influences market access.

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What Are the Challenges and Risks?

Challenge/ Risk	Impact	Mitigation Strategies
Regulatory Hurdles	Delays or denials, impacting revenue timeline	Early engagement with authorities
Market Competition	Price erosion and reduced market share	Unique value propositions and differentiation
Manufacturing Scale-Up	Cost overruns, supply disruptions	Robust process validation, supply chain management
Patent Lifespan	Generics/biosimilars threaten exclusivity	Patent extensions, lifecycle management strategies
Reimbursement & Pricing	Access restrictions, coverage gaps	Engagement with payers, health technology assessments

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Market Size and Revenue Projections

Global Market Size (Indicative):	Year	Estimated Market Size (USD billions)	CAGR (%)	Notes
2023	\$X.X	—	Current estimates
2025	\$X.X	X%	Post-approval market penetration forecast
2030	\$X.X	X%	Long-term growth projections

Assumptions for Financial Forecast:

• Launch Year: [Year]
• Market Penetration at Launch: [e.g., 10-15%] within [first 3 years]
• Average Selling Price (ASP): [e.g., \$XX,000 per patient annually]
• Number of Eligible Patients: [e.g., 1 million globally] by [year]
• Reimbursement Rate: [e.g., 80%]

Revenue Forecast (Simplified):

Year	Projected Patients	Market Penetration	Revenues (USD millions)	Remarks
Year 1	X,000	X%	\$XX	Limited initial penetration
Year 3	Y,000	X%	\$XXX	Post-approval growth
Year 5	Z,000	X%	\$X,XXX	Market stabilization, max potential

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Competitive Landscape Comparison

Competitor	Drug Name	Mechanism	Phase	Market Share	Price Point	Key Differentiators
[Comp 1]	[Name]	[Mechanism]	[Phase]	[X]%	[Pricing]	[Attributes—e.g., efficacy, safety]
[Comp 2]	[Name]	[Mechanism]	[Phase]	[X]%	[Pricing]	[Attributes—e.g., convenience]
INLURIYO	[Proposed Name]	[Mechanism]	[Phase]	Projected X%	Premium/competitive	Innovative delivery, patents

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Financial Trajectory: Investment and Revenue

Development Phase (Pre-Approval):

• R&D Costs: Estimated at \$X million during phase III clinical trials.
• Regulatory Submission Costs: Approx \$Y million.

Post-Approval Revenue Streams:

• Product Sales: Driven by market uptake.
• Licensing Deals: For regional or manufacturing partnerships.
• Milestone Payments: From partnering agreements.

Cost Considerations:

Cost Type	Estimate (USD millions)	Notes
Manufacturing Setup	\$X	Scale-up investment
Marketing & Sales	\$Y	Launch and promotion campaigns
Post-Market Surveillance	\$Z	Safety monitoring and reporting

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Regulatory and Policy Implications

Regulatory Aspect	Impact on Market & Financials	Policies & Timeline
Accelerated Approval Programs	Faster time-to-market, earlier revenue recognition	FDA Fast Track/Breakthrough Therapies (within 6-12 months)
Pricing & Reimbursement Policies	Affects profitability and market access	HTA assessments, payer negotiations
Patent & Data Exclusivity	Extends market protection duration	10-12 years exclusivity in key markets

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Strategic Recommendations

• Prioritize Regulatory Engagement: Maximize opportunities for expedited review processes.
• Differentiate the Product: Through clinical superiority or delivery innovation.
• Optimize Manufacturing Scalability: Reduce costs and ensure supply chain resilience.
• Engage Payers Early: Demonstrate value to facilitate reimbursement.
• Monitor Competitive Movements: Establish a strategic plan for lifecycle management.

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Key Takeaways

• Market expansion for INLURIYO hinges on successful clinical trial outcomes, regulatory approval timing, and strategic positioning against competitors.
• The global market potential exceeds \$X billion, with increasing demand driven by disease prevalence and therapeutic innovation.
• Incorporating value-based pricing strategies and early payer engagement will be critical for sustainable revenue growth.
• Market entry will face headwinds from established competitors and biosimilars, necessitating differentiation through clinical efficacy or delivery mechanisms.
• Long-term success relies on robust manufacturing, lifecycle management, and ongoing innovation.

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FAQs

1. When is INLURIYO expected to receive regulatory approval?

Based on current clinical timelines, [company] anticipates submitting the NDA in [year], with potential approval in [year + 1 or 2], subject to regulatory review outcomes.

2. What is the estimated market size for INLURIYO?

The global [indication] market is projected to reach \$X billion by [year], with INLURIYO aiming to capture [target percentage] of this market post-launch.

3. How does INLURIYO differentiate from competitors?

INLURIYO's differentiation strategy involves [e.g., improved safety profile, better efficacy, convenient delivery, oral formulation, etc.], which could support premium pricing and enhanced market share.

4. What are the main risks affecting INLURIYO's financial success?

Key risks include regulatory delays, market competition, manufacturing challenges, and reimbursement hurdles. Proactive mitigation strategies are essential.

5. What is the expected timeline for revenue realization?

Revenue should begin [e.g., 1-2 years after approval], with revenue growth scaling over [the next 3-5 years] as market penetration increases and reimbursement coverage improves.

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References

[1] GlobalData. "Market forecasts for autoimmune diseases," 2022.
[2] FDA Guidance Documents. Fast Track and Breakthrough Therapy Designations, 2021.
[3] IQVIA. "Pharmaceutical Market Outlook," 2022.
[4] Pharma Intelligence. "Competitive landscape analysis," 2022.
[5] Company filings and regulatory submissions, [year].

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The insights provided serve as a strategic foundation for stakeholders evaluating the commercial opportunity of INLURIYO. Continuous monitoring of clinical developments, regulatory changes, and competitor actions remains imperative.