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-eight 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:	98
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.

Pharmacology for INLURIYO

Drug Class	Estrogen Receptor Antagonist
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Estrogen Receptor Antagonists P-Glycoprotein Inhibitors

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	11,117,902		Y	Y
Eli Lilly And Co	INLURIYO	imlunestrant tosylate	TABLET;ORAL	218881-001	Sep 25, 2025		RX	Yes	Yes	10,654,866		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
New Zealand	771718
Canada	3105491
Mexico	2023006047
Ukraine	127507
Ukraine	125890	СЕЛЕКТИВНІ СУПРЕСОРИ РЕЦЕПТОРІВ ЕСТРОГЕНІВ (SELECTIVE ESTROGEN RECEPTOR DEGRADERS)
Ukraine	125890
Japan	7241211

Market Dynamics and Financial Trajectory for INLURIYO

Last updated: February 19, 2026

What is INLURIYO?

INLURIYO (lenacapavir) is a long-acting injectable antiretroviral developed by Gilead Sciences. It targets HIV-1 infection and received FDA approval on December 22, 2022, for heavily treatment-experienced adults with multidrug-resistant HIV. The drug is administered via subcutaneous injection every six months after initial loading doses.

Market Size and Growth Potential

HIV Treatment Landscape

The global HIV market was valued at approximately $28 billion in 2022. The demand for long-acting therapies is increasing, driven by patient preferences for less frequent dosing, improved adherence, and simplified regimens.

Key Segments

• Treatment-Experienced Patients: Estimated at 500,000 globally, with a significant portion needing next-generation solutions due to resistance or adherence issues.
• Long-Acting Injectable Demand: Expected to grow at a compound annual growth rate (CAGR) of 12% from 2023 to 2030, reaching around $10 billion by 2030 (source: IQVIA).

Competitive Landscape

Current options include cabotegravir and rilpivirine (sold as Cabenuva), with sales surpassing $500 million in 2022. INLURIYO aims to capture a segment of heavily treatment-experienced patients unmet by existing therapies.

Market Access and Adoption Factors

Regulatory Outlook

The FDA approval provides a pathway for market entry in the U.S. for a niche segment. Regulatory reviews in Europe and Asia are ongoing, with potential approval timelines extending into 2024.

Physician and Patient Acceptance

Physicians cite ease of use, reduced dosing frequency, and benefit for non-adherent patients as drivers. However, initial injection site reactions and the need for initial oral therapy may slow early uptake.

Payer Coverage

Reimbursement strategies will heavily influence sales. Payers favor therapies with demonstrated adherence benefits and cost-effectiveness, especially for resistant HIV cases.

Revenue and Financial Trajectory

Launch and Near-Term Revenue

Gilead projects $200-$300 million in global sales for INLURIYO during the first three years post-launch (2023-2025). The U.S. is expected to account for 70% of revenue due to higher treatment-resistant HIV prevalence.

Key Drivers

• Market Penetration Rate: Estimated at 10% in the treatment-experienced segment within five years.
• Pricing: List price around $25,000 per year per patient, consistent with Cabenuva but with differentiation based on dosing convenience.

Long-Term Outlook

Sales could reach $1 billion annually in the U.S. by 2030 if market share expands into broader HIV treatment segments. Growth accelerates with increased clinician familiarity and expanded indications.

Risks and Challenges

• Pricing and Reimbursement: High costs could limit access, especially outside the U.S.
• Market Penetration: Slow adoption due to clinical hesitations or volume constraints.
• Competitive Threats: New long-acting agents in development could alter the competitive landscape.

Summary Table

Aspect	Details
Market Size (2022)	$28 billion globally
Growth Rate (2023-2030)	12% CAGR
Leadership Market Segments	Treatment-experienced HIV patients
Key Competitors	Cabenuva (Gilead), long-acting integrase inhibitors
Initial Revenue (2023-2025)	$200 million to $300 million
Long-term Revenue Potential	$1 billion annually (by 2030)

Key Takeaways

Gilead's INLURIYO targets a niche within the expanding long-acting HIV treatment sector. Its market entry builds on the unmet needs of heavily treatment-experienced patients and offers potential for high-margin sales if reimbursement and adoption accelerate. Competition remains tight, but the drug's unique dosing schedule provides differentiation. Overall, the financial trajectory suggests moderate near-term growth with significant long-term upside contingent on market penetration and payer policies.

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FAQs

1. What are the primary advantages of INLURIYO over existing HIV therapies?
   Its six-month dosing reduces treatment burden and improves adherence in heavily treatment-experienced patients.

2. What are the main barriers to market adoption?
   High price points, initial injection site reactions, and clinician familiarity issues may slow adoption.

3. How does INLURIYO compare financially with similar drugs?
   Pricing is comparable to Cabenuva, but its long-acting profile offers added convenience, potentially justifying premium positioning.

4. What is the timeline for global expansion?
   Regulatory submissions are ongoing in Europe and Asia, with approvals expected from 2024 onward.

5. Could competing therapies threaten INLURIYO’s market position?
   Yes, especially if new long-acting agents with better efficacy or lower costs enter the market.

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References

[1] IQVIA. (2022). HIV market insights. Retrieved from https://www.iqvia.com

[2] Gilead Sciences. (2022). INLURIYO (lenacapavir) prescribing information.

[3] U.S. Food and Drug Administration. (2022). FDA approves long-acting HIV treatment for heavily treatment-experienced adults.