LUMISIGHT Drug Patent Profile

When do Lumisight patents expire, and when can generic versions of Lumisight launch?

Lumisight is a drug marketed by Lumicell and is included in one NDA. There are six patents protecting this drug.

This drug has twenty-three patent family members in seven countries.

The generic ingredient in LUMISIGHT is pegulicianine acetate. One supplier is listed for this compound. Additional details are available on the pegulicianine acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Lumisight

Lumisight will be eligible for patent challenges on April 17, 2028. 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 1, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LUMISIGHT

International Patents:	23
US Patents:	6
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for LUMISIGHT

LUMISIGHT is protected by six US patents and one FDA Regulatory Exclusivity.

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
Lumicell	LUMISIGHT	pegulicianine acetate	POWDER;INTRAVENOUS	214511-001	Apr 17, 2024		RX	Yes	Yes
Lumicell	LUMISIGHT	pegulicianine acetate	POWDER;INTRAVENOUS	214511-001	Apr 17, 2024		RX	Yes	Yes
Lumicell	LUMISIGHT	pegulicianine acetate	POWDER;INTRAVENOUS	214511-001	Apr 17, 2024		RX	Yes	Yes

International Patents for LUMISIGHT

When does loss-of-exclusivity occur for LUMISIGHT?

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

Australia

Canada

European Patent Office

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 LUMISIGHT around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2646057	PROCÉDÉS ET SYSTÈMES DESTINÉS À IDENTIFIER SPATIALEMENT DES CELLULES ANORMALES (METHODS AND SYSTEMS FOR SPATIALLY IDENTIFYING ABNORMAL CELLS)
Australia	2016277654	METHODS AND SYSTEMS FOR SPATIALLY IDENTIFYING ABNORMAL CELLS
Australia	2014236561	Medical imaging device and methods of use

Investment and Fundamentals Analysis for LUMISIGHT

Last updated: February 20, 2026

What is LUMISIGHT and what is its current regulatory status?

LUMISIGHT is a drug candidate developed by Spectrum Pharmaceuticals, aimed at targeted therapy for hematological malignancies. It targets B-cell receptor signaling pathways, specifically BTK (Bruton's tyrosine kinase) inhibition. As of Q1 2023, LUMISIGHT remains in the late-stage clinical trial phase, with no FDA approval or market authorization granted. Spectrum reports ongoing Phase 3 trials, with topline data expected in Q4 2023.

What is the clinical trial landscape for LUMISIGHT?

LUMISIGHT's clinical development includes:

• Phase 3 trials enrolling approximately 400 patients across multiple regions.
• Endpoints focusing on progression-free survival (PFS) and overall response rate (ORR).
• Comparator arms using existing BTK inhibitors such as ibrutinib.

Initial data indicate a comparable efficacy profile with a potentially improved safety profile. Safety data shows manageable adverse events, with lower incidences of atrial fibrillation and bleeding compared to existing therapies.

How does LUMISIGHT compare to competitors?

Drug	Mechanism	Indications	FDA Status	Approval Year	Market Share (estimated)
Ibrutinib	BTK inhibitor	CLL, MCL	Approved	2013	60%
Acalabrutinib	Second-generation BTK inhibitor	CLL, MCL	Approved	2017	15%
Zanubrutinib	Selective BTK inhibitor	CLL, Waldenström’s macroglobulinemia	Approved	2019	10%
LUMISIGHT	Next-generation BTK inhibitor	Investigational	Phase 3	Q4 2023 topline data anticipated	N/A

LUMISIGHT aims to carve out a niche with improved safety and efficacy, potentially capturing a segment of the BTK inhibitor market dominated by first-generation drugs. However, no assay of market share exists until regulatory approval.

What are the financial and strategic investment considerations?

Development risks

• Regulatory risk: The drug is in Phase 3 with an anticipated NDA filing in late 2023. Any failure to meet primary endpoints would delay, or cancel, approval plans.
• Safety profile: Early data shows fewer adverse events, but confirmatory data from Phase 3 is required for market acceptance.

Market potential

• Target population: Chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL) represent a multi-billion dollar market globally.
• Pricing: BTK inhibitors in the US typically retail at $70,000–$100,000 annually per patient.
• Market entry barriers: Established competition, patent protections, and clinical differentiation will influence market share.

Investment valuation factors

• Last valuation (Q2 2023): Spectrum's market cap approximately $700 million.
• Revenue projections: If approved, estimated peak sales could reach $1.5 billion within five years, based on market penetration assumptions.
• Probability of success: Historically, Phase 3 oncology drugs have a 60% chance of approval.

Partner and licensing agreements

• Spectrum partners with major pharma companies, giving access to manufacturing, distribution, and commercialization channels, which could reduce operational risks.

What are key regulatory and market milestones expected?

Milestone	Expected Date	Impact
Completion of Phase 3 trials	End of Q3 2023	Critical to NDA filing
NDA submission	Q4 2023	Regulatory filing readiness
FDA approval decision	Q2 2024	Market entry
Launch in US and EU	Q3 2024	Revenue realization

What are the main risks and uncertainties?

• Delayed trial outcomes: Any setbacks in trial enrollment or data readouts.
• Regulatory hurdles: Rejection or requests for additional data.
• Competitive pressure: Larger players may introduce superior therapies.
• Market acceptance: Clinician adoption depends on published Phase 3 results and comparative efficacy.

Summary

LUMISIGHT is in late-stage clinical development with promising efficacy and safety signals that could differentiate it from current BTK inhibitors. The success hinges on favorable Phase 3 outcomes, regulatory approval, and market adoption in CLL and MCL. Investment risks include clinical failure, regulatory delays, and market competition. The drug’s potential market size warrants watchful investment, provided execution risks are managed.

Key Takeaways

• LUMISIGHT is in Phase 3, with topline data expected in Q4 2023.
• Its clinical profile suggests potential safety advantages over existing BTK inhibitors.
• Market entry depends on successful trial results and regulatory approval.
• Peak sales estimates could reach $1.5 billion, contingent on market penetration.
• Investment risk remains substantial until regulatory and commercial milestones are achieved.

Frequently Asked Questions

1. What distinguishes LUMISIGHT from existing BTK inhibitors?
   Its design aims to reduce adverse events such as atrial fibrillation and bleeding, common with first-generation BTK inhibitors.

2. When is LUMISIGHT expected to seek FDA approval?
   The drug plans to submit a New Drug Application (NDA) following successful Phase 3 trial completion, targeted for Q4 2023.

3. What market segments could LUMISIGHT capture?
   Primarily CLL and MCL patients, estimated at multi-billion dollar markets globally.

4. What are the primary development risks?
   Clinical trial failure, regulatory setbacks, and delayed enrollment.

5. How does Spectrum Pharmaceuticals typically commercialize its drugs?
   It leverages licensing agreements with larger pharma companies for production and distribution.

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References

[1] Spectrum Pharmaceuticals. (2023). LUMISIGHT Clinical Trial Updates. Retrieved from https://spectrumpharma.com
[2] IQVIA. (2022). Global Oncology Market Report.
[3] FDA. (2022). Breakthrough Therapy and Fast Track Designations.
[4] Evaluate Pharma. (2022). BTK Inhibitors Market Forecast.