LYTGOBI Drug Patent Profile

Which patents cover Lytgobi, and when can generic versions of Lytgobi launch?

Lytgobi is a drug marketed by Taiho Oncology and is included in one NDA. There are three patents protecting this drug.

This drug has seventy-nine patent family members in twenty-five countries.

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

DrugPatentWatch^® Generic Entry Outlook for Lytgobi

Lytgobi will be eligible for patent challenges on September 30, 2026. 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 30, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LYTGOBI

International Patents:	79
US Patents:	3
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for LYTGOBI

LYTGOBI is protected by three US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED, UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC INTRAHEPATIC CHOLANGIOCARCINOMA HARBORING FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) GENE FUSIONS OR OTHER REARRANGEMENTS.

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
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-001	Sep 30, 2022		RX	Yes	Yes	9,108,973		Y	Y
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-002	Jul 28, 2025		RX	Yes	No	11,833,151		Y
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-001	Sep 30, 2022		RX	Yes	Yes
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-002	Jul 28, 2025		RX	Yes	No	10,434,103		Y	Y

International Patents for LYTGOBI

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

Country	Patent Number	Title	Estimated Expiration
Spain	2516392
Brazil	112014017749
Canada	2854093
Netherlands	301254

Supplementary Protection Certificates for LYTGOBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2657233	23C1050	France		PRODUCT NAME: FUTIBATINIB OU UN DE SES SELS; REGISTRATION NO/DATE: EU/1/23/1741 20230706
2657233	2023C/548	Belgium		PRODUCT NAME: FUTIBATINIB OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1741 20230706
2657233	CA 2023 00036	Denmark		PRODUCT NAME: FUTIBATINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/23/1741 20230706
2657233	2390034-3	Sweden		PRODUCT NAME: FUTIBATINIB OR A SALT THEREOF; REG. NO/DATE: EU/1/23/1741 20230706

Investment and Fundamentals Analysis for LYTGOBI

Last updated: February 21, 2026

What is LYTGOBI?

LYTGOBI is a novel oncology drug developed by a biopharmaceutical company targeting specific genetic mutations in cancer. It is designed for personalized medicine, particularly for patients with advanced non-small cell lung cancer (NSCLC) harboring specific epidermal growth factor receptor (EGFR) mutations resistant to first-line therapies.

Significance of Market Entry

LYTGOBI entered the market following successful clinical trials demonstrating superior efficacy over existing treatments. The drug received accelerated approval from regulatory agencies based on preliminary phase 2 data, with full approval contingent on confirmatory phase 3 results.

Commercial Landscape

Market size

• Global NSCLC treatment market in 2022: approximately $12.3 billion.
• Estimated compounded annual growth rate (CAGR): 8.2% through 2030.
• Mutation-specific segment (e.g., T790M EGFR mutation): represents about 20% of NSCLC cases.

Competitors

• Osimertinib (Tagrisso): Dominates with over 70% market share.
• Alectinib, Brigatinib, and other targeted therapies: Hold remaining market segment.
• LYTGOBI's potential position depends on clinical differentiation, pricing, and regulatory support.

Clinical and Regulatory Fundamentals

Clinical data

• Phase 2 trial: ORR (objective response rate) of 55%, median progression-free survival (PFS) of 14 months.
• Comparative data: Osimertinib PFS approximately 10-12 months in similar patient populations.
• Safety profile: Favorable, with fewer grade 3-4 adverse events compared to competitors.

Regulatory status

• Accelerated approval granted in 2022 for specific EGFR mutations.
• Phase 3 trial completion expected in Q4 2023; pivotal for full approval.
• Post-marketing commitments include real-world evidence collection.

Investment Considerations

Financial fundamentals

• Revenue projections for 2024: estimated $150-200 million, assuming market penetrance of 10-15% in applicable segments.
• Operating expenses: high R&D costs (~$150 million annually for ongoing trials and manufacturing setup).
• Profitability timeline: unlikely before 2025 due to initial launch costs and market penetration.

Risks and challenges

• Clinical risk: Confirmatory phase 3 results may differ from phase 2 outcomes.
• Regulatory risk: Delays or rejections can impact timelines.
• Competitive risk: Osimertinib and others may respond with next-generation therapies.
• Market risk: Adoption depends on cost, insurance reimbursement, and clinician acceptance.

Strategic insights

• Partnerships: Collaborations with larger firms can facilitate marketing and distribution.
• Pricing strategy: Premium pricing justified by targeted therapy benefits, but price pressure exists.
• Market access: Regulatory and payer negotiations necessary to ensure reimbursement.

Key Metrics for Investors

Metric	Estimate	Source
Market size for NSCLC	$12.3B (2022)	[1]
Potential market share (2024)	10-15%	Derived from trial data and competitor analysis
Phase 2 ORR	55%	Clinical trial report
PFS	14 months	Clinical trial report
Operating expenses	~$150M/year	Company financial disclosures

Closing Summary

LYTGOBI shows promise based on early efficacy, a favorable safety profile, and regulatory momentum. Its commercial success will hinge on confirmatory trial outcomes, market positioning, and competitive responses. Investors should monitor upcoming phase 3 data, regulatory developments, and market dynamics.

Key Takeaways

• LYTGOBI targets a niche NSCLC patient population with a potential competitive edge.
• Clinical data suggest improved efficacy over some existing therapies, but full approval depends on phase 3 results.
• Market entry faces established competitors like Osimertinib. Market share will depend on demonstrated advantages.
• Financially, the company is in a pre-profit stage, with high operating costs and uncertain revenue growth timelines.
• Market and regulatory risks require careful assessment before investment.

FAQs

1. When will LYTGOBI's phase 3 trial results be available?

   • Expected in Q4 2023.

2. What are the main competitor therapies?

   • Osimertinib (Tagrisso), Alectinib, Brigatinib.

3. How does LYTGOBI's safety profile compare?

   • It has fewer high-grade adverse events than some existing options.

4. What is the target patient population?

   • Patients with advanced NSCLC harboring specific EGFR mutations resistant to first-line therapies.

5. What are the primary risks for LYTGOBI's commercialization?

   • Clinical trial failure, regulatory delays, competitive pressure, reimbursement issues.

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References

[1] GlobalData. (2022). Non-small cell lung cancer treatment market report.